The designated Review Board Administrator sets up and manages IRB configuration lists, review board options and roles, notifications, various types of document templates and module settings under IRB Board Administration, accessed via IRB Assistant > Review Board Administration.
Navigation in iRIS™
iRIS™ includes two standard navigation tools on all pages nested one or more levels beneath the primary Workspace page of the module currently in use (e.g., Study Assistant, Conflict of Interest Assistant, Animal Resource Center, etc.): a Path directory tree, and Back buttons.
Path Directory Tree
The Path item at the upper left of iRIS™ pages provides a hyperlinked menu directory tree, allowing the user to quickly navigate back through the path they followed to get to their current location. Path appears on all pages nested at least one level beneath the main workspace
In the example shown the user is viewing the Broadcast Notice Add a new notice page in the Animal Resource Center module. This page is nested three levels beneath the main workspace page, as indicated by the three links available in the Path directory tree: Home, board admin and broadcast notice.
Click on broadcast notice in the Path to navigate up one level in the directory tree, to the main Broadcast Notice page. There are now two levels in the Path directory tree: board admin and Home.
Click on board admin in the Path to navigate up one level in the directory tree, to the Board Administration page. There is now one level in the Path: Home.
Click on Home in the Path to navigate up one level in the directory tree, to the main Workspace page. No Path item is displayed here because the user is now at the top-most level of the directory tree.
Back Button
The second navigation tool is the Back button, which appears on all pages nested at least one level beneath the main workspace. The Back button takes the user to the same location as the last link shown in the Path.
In the example shown above, both the Back button and the broadcast notice link in the Path return the user to the Broadcast Notice page:
Clicking the Back button on the Broadcast Notice page returns the user to the Board Administration page, as indicated by the last link in the Path directory tree shown in the screenshot above.
Note that where the Back button appears on a page with editable fields or document upload controls, clicking the button before saving changes returns the user to the same location as the last link shown in the Path without saving changes.
Review Board Limited Administrative Rights
Beginning with iRIS™ version 12.01, a new rb.use_limited_admin_rights property has been created under Board Configuration > Board Setup.
When this property is set to “Yes” an option for limited administrator rights is made available when giving users administrative board level access.
Users assigned Limited Administrative Rights have access to the items shown below under Review Board Administration. Board members can be assigned access to view and edit notifications and letter templates when board level role access is set.
As shown below, users granted this rights level are granted access to the Review Board Administration icon in their main workspace, as well as the corresponding menu link.
Review Board Member History
Beginning with iRIS™ version 12.01, review board role assignments and changes are now available in an audit log, regardless of where the assignment or role change was made in the system.
When a user is added to a review board the system creates an audit log entry that includes the username, the start and end dates for the role assignment, the role title, and the name of the user who made the role assignment.
When an existing board member is assigned to a different role on the same board, the system automatically enters the date of the new assignment as the end date for the user’s previous review board role and as the start date for the new review board role. These dates are then saved to the audit log, along with the name of the user being reassigned, the new role title, and the name of the user who made the change.
Review board role assignment history for users is accessible via the [Board Name] Assistant > User Management > Member History link, as shown below.
Note: availability of this feature is controlled under Review Board Administration > User Roles and Access, and the menu item shown only populates for users in roles that are granted access.
A new Member History icon/link is also available in the workspace for users with access to the Member History page.
When either link is clicked the Member History page opens to the History tab for lookup of user role assignment history. The search form on the page defaults to a range from the current date going back one year, but the dates can be changed.
Enter desired search criteria (Last Name, First Name, Username, Role, Status, date range) and click the Find button to run the search. Use the Display by Committee drop down list at the upper right of the page to filter search results further.
Notice that each user can have multiple history entries, one for each role assignment on each board. A user may also have multiple entries for a role if they held that role for two periods of time.
Click the Print button to print the results displayed on the screen. To print all of the records in the result set, change the records per page drop down to “All”. It is also possible to print to PDF using that browser function.
There are two areas in the system where board role assignments and changes can be entered. The first is the Grant User Access & Define Roles page within a review board module, as shown below.
The second is at the System Administration level, and is accessed via System Administration > System Administration Workspace > User Accounts > Assign Access link for applicable user.
Clicking that icon opens the role assignment page for the applicable user, as shown below.
Deactivating, terminating or retiring a user account also places an end date(s) for any role(s) the user holds at that time.
Common Rule Display
Beginning with iRIS™ version 12.01, a new property is available to display Common Rule applicability. This feature allows review board members and reviewers to easily identify whether a study is subject to the new 2019 Common Rule or is under the 1991 Common Rule, based on the option chosen in the Select Categories for Study drop down select field on the Outcome tab.
A new property, rb.use_common_rule_display, has been added under IRB > Review Board Admin > Board configuration > Study board properties. The property defaults to “No”, and must be changed to “Yes” in order to enable the changes described in this section.
As shown in the screenshot above, a column indicating whether the study is under the 2019 Common Rule (Yes/No displayed depending on the drop down from the Outcome tab, shown below) has been added to the Find a Protocol page.
New studies being submitted should display “Yes” for the 2019 Common Rule column.
A new Common Rule filter has been added to the search box at the top of the Find a Study page. The drop down list includes options to display only “2019 Common Rule Studies”, only “1991 Common Rule Studies”, or “All”. The default setting for this field is “All”.
As shown in the screenshot below, the same changes have been applied to the Board Submissions page.
As shown in the screenshot below, the applicable rule now displays in the Study / Submission header.
An associated Merge Code (“Common Rule”) has also been added to the system for use in Meeting Minutes, Meeting Agendas and Outcome Letters. The Merge Code field populates with the applicable rule.
Sync Documents with Other Boards When Doing Parallel Submissions
Beginning with iRIS™ version 12.01, a new property has been added for IRB, IACUC, IBC, SRB, and Gate keeper boards (rb.use_latest_component_parallel_submission). The default value of this new property is “Yes”.
When the property is set to “Yes” and the submission goes to multiple boards, any new components attached to the submission by Board A will automatically appear under submission components for Board B as well. This ensures all applicable boards always have the latest components in the submission. Setting this value to “No” maintains the previous functionality, where Board B keeps the original components received in the submission.
Note: When this property is set to “Yes” and Board A returns the submission for corrections at the same time as Board B, study members will always see the latest components in the submission and stipulations, no matter what was returned for corrections.
System Setup Tab
System Setup is the first tab on the IRB Board Administration page. This section allows review board administrators to manage general IRB Assistant module setup, define review board details, set up review board roles and access, create document templates and notifications, change labels for data fields within the IRB module, and perform similar module configuration and data management tasks.
This manual provides information about system configuration items under Review Board System Setup (left column in screenshot above).
See the Notifications manual for more information about Review Board Notification Setup items (right column in screenshot above).
Copy Configurations
Copy Configurations is a tool that can be made available to full System Administrators (as opposed to those assigned to an Administrator role within a specific iRIS™ module) to help with initial setup of iRIS™ when two or more similar review boards are needed. The copy tool allows an iRIS™ system administrator to copy pre-existing, fully configured review board elements into a different, newly created review board.
CAUTION: Copy Configurations should not be used after setup of review boards is complete, nor in a live iRIS™ system. iMedRIS recommends performing a board configuration copy to a destination review board only once.
Note that configurations cannot be copied across review boards of different types (IRB to IBC, IRB to ARC, etc.). Within IRB it is only possible to copy configurations across IRB review boards.
Click the Copy Configurations button to copy a pre-existing review board configuration to another review board.
The Copy Review Board Configuration page displays. The page contains links to configurations that can be copied to another review board.
Note the Destination dropdown list at the top center of the page, and the Helpful Information button at right. The Copy Configurations button is non-functional until the Destination and at least one configuration item are selected (details follow below).
Click the Helpful Information button to view a popup containing important information and warnings about copying review board configurations.
Click the close window button in the upper right corner (marked with a red asterisk) to close the popup.
Back on the Copy Review Board Configuration page, select the target review board from the Destination dropdown list at the top of the page. The configuration Source is shown at the upper left, indicating the review board that is currently active. Only review boards of the same type will populate in the Destination dropdown list.
Select boxes for applicable configuration items in the setup lists are now available.
Select the configuration item(s) to be copied to the selected destination by clicking the respective checkbox(es).
Note that the following configuration items of the Source board cannot be copied:
— Board Definition
— Setup Review Board Roles
— Role Access
— Setup Correspondence Template
— Review Cycle
— Study Status Configuration List
Click the Copy Configurations button to complete the copy process. Click the Cancel Copy button to cancel the process without saving changes.
When the Copy Configurations button is clicked the copy process completes, and the Copy Review Board Configuration page refreshes.
Items where there is no data to copy, or where the corresponding field is not turned on in the destination review board, are not copied to the Destination review board.
Any items successfully copied are color coded with green text. Items that did not copy successfully are color coded with red text.
Note: When performing a review board configuration copy from one board to another, fields that were originally pre-populated in the destination board will be overwritten with data copied from the source board.
Export/Import Board Configuration and Letter / Notification Templates to Other iRIS™ Environments
The Download Properties Script button on the Setup System Properties page (shown below, accessed via Home > System Administration > System Configuration) allows the System Administrator to copy system properties from an existing iRIS™ environment into a new, separate iRIS™ environment during initial setup of the separate environment.
The Copy Configurations button on the Copy Review Board Configuration page (shown below, accessed via [board name] > Review Board Administration) is used to copy board-specific configuration details from one board to another of the same type (e.g., IACUC to IACUC, IRB to IRB, etc.) within the same iRIS™ environment. See the System Setup Tab > Copy Configurations section of this manual for details of that process.
The Import/Export Configurations button on the Board Administration page (shown below, accessed via [board name] > Review Board Administration) is used to copy board-specific configuration details from one board to another of the same type (e.g., IACUC to IACUC, IRB to IRB, etc.) in a new, separate iRIS™ environment.
IMPORTANT NOTE: use of this function may replace existing letter templates or notifications. Please consult with iMedRIS technical support team before using this feature.
Board Definition
Review boards are defined, edited and deleted in the Review Board Administration area of IRB Assistant. To define a board, navigate to IRB Assistant > Review Board Administration > [System Setup tab] > Board Definition link.
The Setup Board page is opened.
There are two required fields: Review Board Name and Review Board Type. The Review Board Type dropdown list contains predefined board types as specified in the institution’s contract with iMedRIS Data Corporation. The dropdown is disabled on this page, as the review board type has already been pre-defined in System Administration.
An Institutional Review Board (IRB) must have any required Assurance registered in order to receive research support from various funding and resource institutions. For example, an institution must have a Federalwide Assurance (FWA) registered in order to receive Health and Human Services (HHS) support for research involving human subjects.
Where applicable, enter the registered Assurance Number and Assurance Expiration date. If no Assurance is applicable to the board, skip these fields.
Use the Comments field to enter additional notes or comments about the board.
In the Primary Address section, enter Street, City, State, Zip/Postal Code and Country. This is the address that will appear on board documents and correspondences that include a board address.
In the Primary Phone section, enter the Phone Number designated for contacting the board.
In the Primary E-Mail section, enter the E-mail address designated for contacting the board.
Click the Save Definition button at the upper right to save the record.
Board Configuration Options
To set or revise board configuration options, navigate to IRB Assistant > Review Board Administration > [System Setup tab] > Board Configuration Options link.
The Setup Board Properties page is opened. This page lists properties the administrator can set within the review board module.
It is the System Administrator’s responsibility to determine the property settings that best align with the organization’s preferences before making changes.
If assistance is needed to ensure optimal settings, discuss intended changes with iMedRIS personnel before making the changes.
Click the Download Properties Script button to download a SQL script containing configurations for the review board properties, which can be used to import the configurations into another iRIS™ system.
Click an item in the RB Properties List to load an editable panel containing all properties related to that category.
Where available, Yes/No radio buttons turn the property “on” or “off”. A property with any Property Value other than Yes/No radio buttons is a variable.
See the IRB Assistant — Properties manual for more information on each individual property.
Broadcast Notice
Broadcast Notice allows the system administrator to send an email to review board members and to users on studies associated with the review board. This is a useful tool for sending group alerts and messages.
Note that the Broadcast Notice tool under iRIS™ System Administration—as opposed to System Administration within a module like IRB—can send a message to all users in the iRIS™ system. The System Administrator must be cautious to use the correct Broadcast Notice tool for their purposes.
To access Broadcast Notice options, navigate to IRB Assistant > Review Board Administration > [System Setup tab] > Broadcast Notice link.
The Broadcast Notice page displays any broadcasts previously set up/sent out. The list is empty the first time the page is opened.
Add a New Notice
Navigate to IRB Assistant > Review Board Administration > [System Setup tab] > Broadcast Notice link.
The Broadcast Notice page displays any broadcasts previously set up/sent out. The list is empty the first time the page is opened.
Click the Add a New Notice button to create and send a message. The Add a new notice panel opens.
Click the Return to List button to cancel and return to the list of broadcast notices.
The Temp Save Notice button is used to save a notice draft, explained in greater detail in the Draft Notice subsection of this manual, immediately following the current subsection.
Enter a Subject and type, or copy and paste, desired text in the Content area. Use the toolbar to format text as desired. Notice that tools for insertion of hyperlinks and images are included.
Click the Add a new Attachment button to attach a document file to the notice.
An upload panel opens. Enter the Title of the document and click the Upload button.
An upload dialog popup window displays.
Click the Cancel button to close the popup without uploading a document.
Click the Browse button to navigate to the document to be uploaded. When the file path is displayed in the Document Location field, click the Save selected file button to attach it to the notice record.
The Add Attachment panel refreshes, displaying an icon for the attachment to the left of the Title. Click the Save and Return button save the notice and attachment.
The attached document icon displays in a table in the Attachments area of the Edit/View a notice panel.
To view an attachment, click its icon.
To remove an attachment, click the select checkbox to the left of the document icon and click the Delete Selected Attachment(s) button.
Note that multiple attachments can be added, but users are still subject to institution or email server restrictions on file size for email attachments.
Click the Send button at the upper right corner of the Edit/View a notice panel to send the notice. A popup email distribution window opens for selection of notice recipients.
Click the Cancel button to exit without sending.
Note that Send to KSPs and review board members is selected by default when the popup opens. Click the checkbox to deselect that option and unlock the other two options: Send to all KSPs and Send to review board members.
Select the applicable checkbox, then click the popup window Send button.
After the notice is sent the Broadcast Notice page displays, with the sent broadcast notice added to the list and its Date Sent field populated.
Note that the Edit/View icon is still present but the select box at the far left, for notice deletion, is gone. Sent notices can be viewed but cannot be edited or deleted.
Draft Notice
When creating a new notice in the Add a new notice panel, it is possible to save the notice as a draft.
Enter a Subject line and desired content, then click the Temp Save Notice button to save a draft of the notice and return to the Broadcast Notice page. Note that draft notices do not have a Date Sent value in the list on the Broadcast Notice page.
Edit a Broadcast Notice
Draft broadcast notices can be edited (and sent) or deleted. Notices that have been sent cannot be deleted or edited, but they can be viewed.
Navigate to IRB Assistant > Review Board Administration > [System Setup tab] > Broadcast Notice link.
The Broadcast Notice page displays any broadcasts previously set up/sent out.
Draft notices do not have a value in the Date Sent column (see screenshot above), which is how they can be easily identified in the Broadcast Notice list.
Click the icon in Edit/View column to the left of a draft title to open the draft and resume work on it.
The title of the Add a new notice panel changes to Edit/View a notice when a draft is opened.
Click the Return to List button to return to the Broadcast Notice list page without saving changes.
Click the Temp Save Notice button to save changes and keep the notice as a draft.
Click the Send button to save changes and send the notice.
A popup email distribution window opens for selection of notice recipients. Click Cancel to exit without sending.
Note that Send to KSPs and review board members is selected by default when the popup opens. Click the checkbox to deselect that option and unlock the other two options: Send to all KSPs and Send to review board members.
Select the applicable checkbox, then click the popup window Send button.
After the notice is sent the Broadcast Notice page displays, with the Date Sent field populated for the sent notice. Recall that sent notices cannot be edited or deleted.
Delete a Broadcast Notice
Draft broadcast notices can be edited (and sent) or deleted. Notices that have been sent cannot be deleted.
Navigate to IRB Assistant > Review Board Administration > [System Setup tab] > Broadcast Notice link.
The Broadcast Notice page displays any broadcasts previously set up/sent out. Note that the Date Sent column is blank for draft notices listed here.
Select the checkbox at far left for the applicable notice and click the Delete Selected Notice button.
A confirmation popup window displays.
Click CONFIRM to delete the notice and return to the Broadcast Notice page.
Click CANCEL to return to the Broadcast Notice page without deleting the notice.
Setup Committee List
The Setup Committee List page is where current review board committees can be viewed, edited or deleted, and new committees added.
Where the property rb.use_submission_by_committee is set to “Yes” the review board is set up for Committee Submissions. In this configuration submissions are routed to individual committees instead of the review board. In addition, members of one committee are unable to access submissions sent to other committees.
Where the property rb.use_submission_by_committee is set to “No” all submissions are routed to the review board submission queue, where they are processed and added to the appropriate committee meeting date. Note that each committee has its own set of meeting dates.
Edit Committee
Navigate to IRB Assistant > Review Board Administration > [System Setup tab] > Setup Committee List link.
The Setup Committee List page is opened. Committees currently assigned to the review board are listed here. Click the icon in the Edit column for the applicable committee.
An edit panel opens.
The Order Number defines routing priority order for the committee. Routing priority goes in ascending order, beginning with zero. If there is only one committee defined its Order Number will always be zero.
The Description is the committee name.
When changes are complete click the Save Committee button to save changes and close the edit panel.
Add Committee
Navigate to IRB Assistant > Review Board Administration > [System Setup tab] > Setup Committee List link.
The Setup Committee List page is opened. Click the Add a Committee button.
A System Authentication popup displays, warning that only iMedRIS Project Managers and Customer Support personnel have the necessary rights to add new review board committees.
This area is locked because there are costs to the institution for each review board and committee defined in their iRIS™ system.
When an iMedRIS Project Manager or Customer Support representative adds a new committee, it is added to the Setup Committee List page.
User accounts assigned to more than one review board committee will have a slightly modified main menu, enabling them to select the applicable committee for various tasks.
Delete Committee
Navigate to IRB Assistant > Review Board Administration > [System Setup tab] > Setup Committee List link.
The Setup Committee List page is opened. Select the checkbox for the applicable committee(s) and click the Delete Selected Committee(s) button.
A confirmation popup displays.
Click the CANCEL button to return to the Setup Committee List page without deleting the selected committee(s).
Click the CONFIRM button to confirm the deletion and return to the Setup Committee List page.
Note: caution must be exercised when deleting committees, as deleting a committee with review tasks assigned to it will disrupt and potentially orphan those tasks.
Also recall that review board committees can only be added by designated iMedRIS personnel, so if a needed committee is deleted in error there may be some delay in recreating it.
Setup Review Board Roles
The Setup Roles List page is where review board member roles can be viewed, edited or deleted, and new roles added. Each member role can be customized to allow for inclusion or exclusion on agenda and correspondence routing, as well as to allow for or prohibit designation of an alternate iRIS™ user to fulfill the duties of the role when the assigned user is unavailable.
Filter By In Use is set to “Yes” by default. Select “No” here to display roles that are not currently in use. Note that this is a toggled setting, it is not possible to view both in use and not in use roles in a single list.
Columns in the Setup Roles List table are:
— Delete: where it is possible to delete a role, click the icon in this column to delete a role record; note that the icon does not appear for roles that cannot be deleted
— Edit: click the icon in this column to open a role record for editing
— Order: priority number of the role for review, signoff and correspondence routing; note that priority numbers are ranked in ascending order from highest to lowest, beginning with one (1) as the highest priority number
— Role Name: name assigned to the role; note that role names can be modified by the institution
— Reserved: a “Yes” in this column indicates the role is Reserved and cannot be deleted; a “No” here indicates the role is not Reserved and can be deleted, provided it is not currently in use (see next item, below)
— In-Use: a “Yes” in this column indicates the role is currently in use on one or more studies / protocols and cannot be deleted; a “No” here indicates the role is not currently in use and can be deleted
— Allow Alternate: a “Yes” in this column indicates an alternate person who is included in the Alternate For list under IRB Assistant > User Management > Grant User Access & Define Roles can be selected to fulfill the meeting duties of this role when the primary assignee is unavailable; a “No” here indicates no alternate can be specified for the role
— Include on Agenda: a “Yes” in this column indicates users assigned to the role are selectable in the list of Attendees for a meeting date; where the flag is set to “No” users assigned to the role do not display in the meeting Attendees list for a meeting date and are not included in notifications related to the meeting
— Include in Correspondence: a “Yes” in this column indicates persons assigned to this role is/are to be included on the correspondence routing list; a “No” here indicates persons assigned to this role is/are not included on the correspondence routing list
As shown below, ten Reserved review board roles are predefined by default.
Reserved roles are always designated as In-Use regardless of whether the applicable role is currently assigned to any studies/protocols.
In the example below, Filter By In Use is toggled to “No” to limit the list to Roles not currently in use. Notice that the role is not Reserved, as indicated by a “No” in that column, and a Delete icon is provided for the role.
Edit Board Role
Navigate to IRB Assistant > Review Board Administration > [System Setup tab] > Setup Review Board Roles link.
The Setup Roles List page is opened.
Filter By In Use is set to “Yes” by default. Select “No” here to display roles that are designated as not in use. Note that this is a toggled setting, it is not possible to view both in use and not in use roles in a single list.
Click the icon in the Edit column for the role.
The role is opened for editing in the Edit a Board Role panel. Edit each item in the panel as desired.
— Order Number: priority number of the role for review, signoff and correspondence routing; note that priority numbers are ranked in ascending order from highest to lowest, beginning with one (1) as the highest priority number
— In-Use: a selection of “Yes” indicates the role is currently in use on one or more studies / protocols and cannot be deleted; a selection of “No” here indicates the role is not currently in use and can be deleted
— Role Name: name assigned to the role; note that role names can be modified by the institution
— Allow Alternate for Meetings: a selection of “Yes” indicates an alternate person who is included in the Alternate Member For list under IRB Assistant > User Management > Grant User Access & Define Roles can be selected to fulfill the meeting duties of this role when the primary assignee is unavailable, as shown below; a “No” here indicates no alternate can be specified for the role
— Include in Minutes and Agenda?: a selection of “Yes” indicates users assigned to the role are selectable in the list of Attendees for a meeting date; where the flag is set to “No” users assigned to the role do not display in the meeting Attendees list for a meeting date and are not included in notifications related to the meeting
— Include in Correspondence: a selection of “Yes” indicates persons assigned to this role is/are to be included on the correspondence routing list; a “No” here indicates persons assigned to this role is/are not included on the correspondence routing list
Make desired edits and click the Save button to save changes, close the edit panel and return to the Setup Roles List page. Click the Back To List button to return to the Setup Roles List page without saving changes.
Add Board Role
Navigate to IRB Assistant > Review Board Administration > [System Setup tab] > Setup Review Board Roles link.
The Setup Roles List page is opened. Click the Add a New Board Role button.
The Add a Board Role panel opens for the role, with the same fields and buttons as the edit panel.
Default selections for the Add a Board Role panel are shown above. Note that the Order Number field defaults to the next available Order Number, based on the existing list of roles.
Enter the desired Role Name and edit other items as desired.
— Order Number: priority number of the role for review, signoff and correspondence routing; note that priority numbers are ranked in ascending order from highest to lowest, beginning with one (1) as the highest priority number
— In-Use: a selection of “Yes” indicates the role is currently in use on one or more studies / protocols and cannot be deleted; a selection of “No” here indicates the role is not currently in use and can be deleted
— Allow Alternate for Meetings: a selection of “Yes” indicates an alternate person who is included in the Alternate For list under IRB Assistant > User Management > Grant User Access & Define Roles can be selected to fulfill the meeting duties of this role when the primary assignee is unavailable; a “No” here indicates no alternate can be specified for the role
— Include in Minutes and Agenda?: a selection of “Yes” indicates users assigned to the role are selectable in the list of Attendees for a meeting date; where the flag is set to “No” users assigned to the role do not display in the meeting Attendees list for a meeting date and are not included in notifications related to the meeting
— Include in Correspondence: a selection of “Yes” indicates persons assigned to this role is/are to be included on the correspondence routing list; a “No” here indicates persons assigned to this role is/are not included on the correspondence routing list
Click the Save button to save changes and return to the Setup Roles List page. Click the Back To List button to return to the Setup Roles List page without saving changes.
Delete Board Role
Navigate to IRB Assistant > Review Board Administration > [System Setup tab] > Setup Review Board Roles link.
The Setup Roles List page is opened.
Because Reserved roles and in-use roles cannot be deleted, there are no icons in the Delete column for those roles on the Setup Roles List page.
Change the Filter By In Use option to “No” and click the Find button to view a list of roles that can be deleted. Click the icon in the Delete column to delete a role.
A confirmation popup window appears. Click CANCEL to return to the Setup Roles List page without saving changes. Click CONFIRM to delete the role and return to the Setup Roles List page.
Setup Role Access
The Setup Role Access page is where the System Administrator assigns read and write access privileges to review board roles for applicable iRIS™ pages.
Navigate to IRB Assistant > Review Board Administration > [System Setup tab] > Setup Role Access link.
The Setup Role Access page is opened.
All applicable iRIS™ pages for the module are listed in a column at the left side of the matrix. Column headers display all applicable review board roles.
The System Administrator assigns Read and Write privileges for each page by role. The applicable system page is shown in the column at left, and the System Administrator clicks the Read and/or Write select checkboxes in the role columns at right to assign the applicable rights.
If both are selected, users assigned to the role can view and update records on the applicable page. If the page allows for record deletion, users assigned to a role with both Read and Write access for the page can delete records on the page as well.
If Read is selected but Write is not, users assigned to the role can view the applicable page but cannot modify or delete records on the page.
Note that any role with Write access must also have Read access assigned.
The first two Read and Write columns do not have an associated role. These columns are used to turn access on or off for the applicable page, regardless of user role. Settings in these columns override settings in the role-specific columns to the right.
To make a given page read-only for all iRIS™ users, the system administrator selects the Read checkbox and de-selects the Write checkbox for the page.
To hide a page entirely the System Administrator de-selects both checkboxes for the page.
Where both checkboxes are selected for a given page, the system administrator can assign Read and Write access per role using the checkboxes in the columns at the right.
Click the Save Changes button to save changes.
Note: The page may take a few moments to save; wait for the page to finish loading before navigating away.
Setup Consent Checklist
The Setup Consent Checklist page allows for creation of a consent checklist for the review board to use when evaluating consent forms. Users can also order, edit, and delete existing checklist items.
To access the page, navigate to IRB Assistant > Review Board Administration > [System Setup tab] > Setup Consent Checklist link.
The Setup Consent Checklist page opens, as shown below.
Change Consent Checklist Item Order
The Checklist Item column contains the priority order number for items in the list. When the checklist is viewed items appear in ascending order by Checklist Item, beginning with “0” (zero).
In the example below, both items have a Checklist Item order number of “1” (one), meaning neither is higher priority than the other. These items appear in the checklist in the same order they are shown on this page.
To change the priority order, enter the desired order number in the Checklist Item column and click the Save Checklist button. For example, to make “Use a study design to describe all procedures” the first item in the checklist:
— change the Checklist Item number for “Consent 1” from “1” (one) to “2” (two) — OR —
— change the Checklist Item number for “Use a study design to describe all procedures” to “0” (zero)
Add Consent Checklist Item
Navigate to IRB Assistant > Review Board Administration > [System Setup tab] > Setup Consent Checklist link.
The Setup Consent Checklist page opens, as shown below.
Click the Add a New Item button.
The Consent Checklist Item Editor opens, as shown below. Enter consent item text and format it as desired, then click the Save button (upper right corner) to save changes and close the text editor.
The new item is added to the list of checklist items, as shown below. Notice that it is automatically assigned a Checklist Item number of “1” (one), so it is added to the bottom of the list. See the Change Consent Checklist Item Order section of this manual for details of how to change checklist item order.
Edit Consent Checklist Item
Navigate to IRB Assistant > Review Board Administration > [System Setup tab] > Setup Consent Checklist link.
The Setup Consent Checklist page opens, as shown below.
Click the applicable icon in the Edit column (see screenshot above).
The Consent Checklist Item Editor opens, as shown below. Revise consent item text and format it as desired, then click the Save button (upper right corner) to save changes and close the text editor.
The item is revised in the list of checklist items, as shown below.
Notice that the revised item retains its Checklist Item number of “1” (one), so it remains in the same position in the list. See the Change Consent Checklist Item Order section of this manual for details of how to change checklist item order.
Delete Consent Checklist Item
Navigate to IRB Assistant > Review Board Administration > [System Setup tab] > Setup Consent Checklist link.
The Setup Consent Checklist page opens, as shown below.
Select the checkbox(es) in the far left column for the item(s) to be deleted. To select or deselect ALL items, click the select icon in the far left column header ( ). Click the Delete Selected Item(s) button.
A confirmation popup window appears. Click CANCEL to close the popup without saving changes. Click CONFIRM to delete the checklist item and close the popup.
As shown below, the item is deleted from the list.
Setup Electronic Document Stamp
The electronic document stamp applies pre-configured review board outcome details to documents in a pre-designated location, as shown in the example below.
Electronic document stamps are configured on the Setup Document Stamp page, shown below.
Add Electronic Document Stamp
Navigate to IRB Assistant > Review Board Administration > [System Setup tab] > Setup Electronic Document Stamp link.
The Setup Document Stamp page opens.
Click the Add a New Stamp button. An add panel opens for creation of the new stamp, as shown below.
Notice that some of the fields in the add panel contain default values. Complete the add panel fields as follows.
Title — enter the desired title of the stamp as it will appear in the list on the main Setup Document Stamp page list
Type — click in the field to open a dropdown picklist of options, then click on the desired option to select it: General Purpose (used for all documents, including consent and other study documents), Informed Consent (used only on consent forms), and Study Document (used only for other study documents); when Study Document is selected a Category dropdown list field appears for selection of the specific document type, as shown below
Note that the study document Category list is configured under My Workspaces > System Administration > List Configuration and Maintenance > Site List Setup tab > Study Document Category.
Also note that while it is not visible in the screenshot above, “Consent form” can be included in the configuration list at institutions performing research with human study subjects, or where animal owners are required to provide consent for the use of their animals in research.
Comments — add any desired comments, such as a description of the stamp type
Show Stamp On —select “Last Page Only” to display the stamp only on the last page, or leave the default value of “All Pages” selected to display the stamp on all pages
Use placeable stamp — select this box to unlock the Coordinate (from bottom left) fields, shown below, which allow for exact placement on the document page; entire the desired X/Y coordinates to specify where the stamp should appear relative to the bottom left corner of the document page
Stamp Position On Page — use this field as an alternative to the Use placeable stamp option for stamp placement on the page; click to select “Top Left”, “Top Center”, “Top Right”, “Bottom Left”, “Bottom Center” or “Bottom Right”
Font Type — click in the field to open a dropdown list of available font options, then click the desired list item to select it
Font Size — click in the field to open a dropdown list of available font size options, then click the desired list item to select it
Font Color — click in the field to open a dropdown list of available font colors, then click the desired list item to select it
Opacity — enter an opacity value between .01 and 1.0, where 1.0 indicates 100% opaque, to set the relative transparency of the stamp
Scale Image to Fit — select this checkbox to automatically scale any uploaded images to fit within the stamp
Click the Upload button. An upload dialog box opens, as shown below.
Browse to the desired image file and select it, then click the Save selected file button to complete the upload. Note that the image file must be in JPEG (.jpg, .jpeg) format.
An example of the completed add panel is shown below.
Click the Preview Stamp Layout button to preview the stamp in a popup window.
Click the Save Stamp Details button to save the stamp after previewing it. As shown below, the stamp is added to the list on the Setup Document Stamp page.
Edit Electronic Document Stamp
Navigate to IRB Assistant > Review Board Administration > [System Setup tab] > Setup Electronic Document Stamp link.
The Setup Document Stamp page opens.
Click the icon in the Edit column for the applicable stamp. The stamp is opened in an edit panel, as shown below.
Make desired changes to the stamp fields, described below.
Title — enter the desired title of the stamp as it will appear in the list on the main Setup Document Stamp page list
Type — click in the field to open a dropdown picklist of options, then click on the desired option to select it: General Purpose (used for all documents, including consent and other study documents), Informed Consent (used only on consent forms), and Study Document (used only for other study documents); when Study Document is selected a Category dropdown list field appears for selection of the specific document type, as shown below
Note that the study document Category list is configured under My Workspaces > System Administration > List Configuration and Maintenance > Site List Setup tab > Study Document Category.
Also note that while it is not visible in the screenshot above, “Consent form” can be included in the configuration list at institutions performing research with human study subjects, or where animal owners are required to provide consent for the use of their animals in research.
Comments — add any desired comments, such as a description of the stamp type
Show Stamp On —select “Last Page Only” to display the stamp only on the last page, or leave the default value of “All Pages” selected to display the stamp on all pages
Use placeable stamp — select this box to unlock the Coordinate (from bottom left) fields, shown below, which allow for exact placement on the document page; entire the desired X/Y coordinates to specify where the stamp should appear relative to the bottom left corner of the document page
Stamp Position On Page — use this field as an alternative to the Use placeable stamp option for stamp placement on the page; click to select “Top Left”, “Top Center”, “Top Right”, “Bottom Left”, “Bottom Center” or “Bottom Right”
Font Type — click in the field to open a dropdown list of available font options, then click the desired list item to select it
Font Size — click in the field to open a dropdown list of available font size options, then click the desired list item to select it
Font Color — click in the field to open a dropdown list of available font colors, then click the desired list item to select it
Opacity — enter an opacity value between .01 and 1.0, where 1.0 indicates 100% opaque, to set the relative transparency of the stamp
Scale Image to Fit — select this checkbox to automatically scale any uploaded images to fit within the stamp
Click the Upload button. An upload dialog box opens, as shown below.
Browse to the desired image file and select it, then click the Save selected file button to complete the upload. Note that the image file must be in JPEG (.jpg, .jpeg) format.
Click the Preview Stamp Layout button to preview the stamp in a popup window.
Click the Save Stamp Details button to save the stamp after previewing it.
Delete Electronic Document Stamp
Navigate to IRB Assistant > Review Board Administration > [System Setup tab] > Setup Electronic Document Stamp link.
The Setup Document Stamp page opens.
Select the checkbox(es) in the far-left column for the stamp(s) to be deleted and click the Delete Stamp(s) button.
A confirmation popup displays.
Click the CANCEL button to return to the Setup Document Stamp page without deleting the selected committee(s).
Click the CONFIRM button to confirm the deletion and return to the Setup Document Stamp page. The stamp is deleted.
Setup Study Numbering
The iRIS™ system includes the option to generate and automatically assign pre-configured IRB study numbers.
Navigate to IRB Assistant > Review Board Administration > [System Setup tab] > Setup Study Numbering link.
The Setup Board Auto Generated Numbering page opens.
Select “Yes” for Use Sequence for IRB Number to enable auto generated IRB study numbering.
As demonstrated in the Description of Number Part column, the number can be configured to include a Constant Prefix, School Code, Calendar Year and System Generated Number. Selecting the checkbox in the Use in Number column includes all items in that row in the numbering scheme.
Options to pad the System Generated Number with leading zeroes, set a fixed digit count for numbers to be generated, and insert an optional Separator character are also available.
In the screenshot shown above a numbering scheme that employs all options except School Code is configured.
The Constant Prefix is “IRB”.
The first Separator character is “ – “.
The School Code option is not selected, indicating that no School Code is included in the number.
The All 4 digits of the current Calendar Year are “20”.
The second Separator character is “ – “.
The first sequence number to be used is “89”, the checkbox for Zero Pad the Sequence Number is selected and Number of Digits is set to “3”.
The first wean number generated by this scheme would be:
IRB-2020-089
Click the Save Numbering button to save the numbering scheme.
Setup Outcome Letter Groups
The Setup Board Letter Templates page is accessed via IRB Assistant > Review Board Administration > [System Setup tab] > Setup Outcome Letter Groups link. As shown below, the Letter Types dropdown picklist on the add/edit panel of the page includes two default letter group entries:
— Outcome - General: letter templates of this type appear as options available for selection on the Outcome Letter tab of submission processing screens
— Submission: letter templates of this type appear as options available for selection on the Submission Received Notification Letter tab of submission processing screens
The iRIS™ system allows for collecting sets of review board forms into additional, custom configured Letter Type groups for assignment to different board review types.
Custom configured Letter Type groups are added to the Letter Type dropdown list on the Setup Board Letter Templates page shown in the screenshot above, and are optionally made available on the Outcome Letter tab of submission processing screens according to rules established at the time a Letter Type group is created or revised (see Add Outcome Letter Group and Edit Outcome Letter Group subsections of this manual, below).
Letter Type groups are configured on the Setup Board Letter Group List page, shown below.
Add Outcome Letter Group
Navigate to IRB Assistant > Review Board Administration > [System Setup tab] > Setup Outcome Letter Groups link.
The Setup Board Letter Group List page opens. Click the Add Group button.
An add panel is opened for creation of the group. Enter the desired Group Name, as shown below, then click the Add button at right.
A popup opens for selection of review board forms to be included in the group. Note that because forms are custom configured for each institution, the list of forms shown here will vary.
Click the Cancel button to close the popup without adding any forms to the group.
Select the checkbox(es) in the far-left column for all forms to be included in the group, then click the Select button to add them to the group and close the popup. As shown below, the selected forms are added to the list of forms on the add panel.
If any forms were selected from the popup list in error, select the checkbox(es) for any forms to be removed from the group and click the Remove button.
Select or de-select the applicable checkboxes to make each form listed available/unavailable as part of the group according to board review type when the group is selected in the Notification Letter dropdown list in the Outcome Letter section of submission processing screens (shown below).
Note that all forms in the group are made available to the Full Board Review type by default.
An example of the fully configured group is shown in the screenshot below.
Click the Save All Changes button to save the new group. As shown below, the group is added on the Setup Board Letter Group List page.
The new Letter Type group is also added to the Letter Type dropdown list on the Setup Board Letter Templates page and is made available on the Outcome Letter tab of submission processing screens for the specified board review types.
Edit Outcome Letter Group
Navigate to IRB Assistant > Review Board Administration > [System Setup tab] > Setup Outcome Letter Groups link.
The Setup Board Letter Group List page opens. Click icon in the Edit column for the applicable group.
The group is opened for editing. Make any desired changes to the Group Name.
To remove forms from the group, select the applicable checkbox(es) in the far-left column and click the Remove button.
To add forms to the group, click the Add button.
A popup opens for selection of review board forms to be included in the group. Note that because forms are custom configured for each institution, the list of forms shown here will vary.
Click the Cancel button to close the popup without adding any forms to the group.
Select the checkbox(es) in the far-left column for all forms to be added the group, then click the Select button to add them to the group and close the popup.
Select or de-select the applicable checkboxes to make each form listed available/unavailable as part of the group according to board review type when the group is selected in the Notification Letter dropdown list in the Outcome Letter section of submission processing screens (shown below).
Note that all forms in the group are made available to the Full Board Review type by default.
In the example screenshot below, checkboxes for the Expedite board review type are de-selected. Applying this change means that the forms shown will not be included in the IRB Correction Forms group when it is selected from the Notification Letter dropdown list (see screenshot above) for submissions assigned to the Expedite board review type.
Click the Save All Changes button to save changes and close the edit panel.
Delete Outcome Letter Group
Navigate to IRB Assistant > Review Board Administration > [System Setup tab] > Setup Outcome Letter Groups link.
The Setup Board Letter Group List page opens. Select the checkbox(es) for the group(s) to be deleted and click the Delete Group(s) button.
A confirmation popup displays.
Click the CANCEL button to return to the Setup Board Letter Group List page without deleting the selected template(s).
Click the CONFIRM button to confirm the deletion and return to the Setup Board Letter Group List page.
Setup Agenda Categories
Where the property rb.use_meeting is set to “Yes” (accessed via IRB Assistant > Review Board Administration > [System Setup tab] > Board Configuration Options > Submission Review Properties link), the iRIS™ system provides the ability to configure a list of agenda topic categories that are frequently addressed in review meetings, including the ability to attach relevant forms or documents where applicable.
The configured list appears on the Meeting Agenda page, as shown below.
Once configured, the categories can be added to a finalized agenda template with just a few clicks rather than repetitive keystrokes (see the Setup Finalized Agenda Document Template section of this manual for more information).
This functionality is provided on the Set-up Agenda Categories page. To access the page, click the Setup Agenda Categories link under IRB Assistant > Review Board Administration > System Setup tab.
The Set-up Agenda Categories page opens, as shown below.
Columns and controls on this page are:
— select: far-left column, no header label; select the desired checkbox(es) here to select the corresponding record(s)
— Edit: click the icon in this column to open the corresponding category for editing
— Group Name: designated category name
— Merge Code: designated short text to be used in document templates, such as the Finalized Agenda Document Template, to pull the corresponding category name and any associated form or document requirements into the template
— Group Display Order: the order in which the applicable category is to be shown on the meeting agenda
— Add Agenda Filter button: click this button to open the Set-up Agenda Filter page, where rules can be configured to exclude study or review item documents from the meeting agenda that would otherwise be captured by an agenda category (see next subsection of this manual, Agenda Filter)
— Add Group button: click this button to open an add panel for creation of a new agenda category
— Delete Group(s) button: click this button to delete any agenda category selected in the far-left column
Agenda Filter
On the Set-up Agenda Filter page (shown below, accessed via the Add Agenda Filter button on the Set-up Agenda Categories page, see previous section of this manual), agenda filters are configured to group review document items. Once configured, agenda filters can be applied to include or exclude certain document types when assigning documents to agenda categories.
Columns and controls on this page are:
— select: far-left column, no header label; select the desired checkbox(es) here to select the corresponding record(s)
— Edit: click the icon in this column to open the corresponding filter for editing
— Filter Type: name of category / type of exclusion
— Filter Name: defaults to same value as Filter Type
— Add Filter button: click this button to open an add panel for creation of a new filter
— Delete Filter(s) button: click this button to delete any filter selected in the far-left column
Add Agenda Filter
Click the Add Agenda Filter button on the Set-up Agenda Categories page.
As shown below, the Set-up Agenda Filter page opens.
Click the Add Filter button. As shown below, an add panel is opened for creation of the new filter.
Click in the Filter Type field to open a dropdown picklist. Click the desired list item to select it.
As shown below, in the case of any Filter Type selection other than “Filter User Defined” the Filter Name field automatically populates with text corresponding to the selected Filter Type and is set to read only.
See the Filter User Defined subsection of this manual for more information about configuring user defined filters.
Click the Save All Changes button to save the filter and close the add panel. As shown below, the filter is added to the list on the Set-up Agenda Filter page.
Edit Agenda Filter
Click the Add Agenda Filter button on the Set-up Agenda Categories page.
As shown below, the Set-up Agenda Filter page opens. Click the icon in the Edit column for the applicable filter.
As shown below, the record is opened in an edit panel. Click in the Filter Type field to expand the dropdown picklist and select the desired item.
As shown below, in the case of any Filter Type selection other than “Filter User Defined” the Filter Name field automatically populates with text corresponding to the selected Filter Type and is set to read only.
See the Filter User Defined subsection of this manual for more information about configuring user defined filters.
Click the Save All Changes button to save changes and close the edit panel. As shown below, the filter is revised in the list on the Set-up Agenda Filter page.
Delete Agenda Filter
Click the Add Agenda Filter button on the Set-up Agenda Categories page.
As shown below, the Set-up Agenda Filter page opens. Select the checkbox(es) in the far-left column for the filter(s) to be deleted, then click the Delete Filter(s) button.
A confirmation popup window displays.
Click CANCEL to return to the Set-up Agenda Filter page without deleting the filter(s).
Click CONFIRM to delete the filter(s) and return to the Set-up Agenda Filter page. As shown below, the selected filter is removed.
Filter User Defined
Note that familiarity with Structured Query Language (SQL), as well as a thorough knowledge of iRIS™ application modules, associated tables, custom forms and fields are required to create user defined filters using this feature. The example used in this section sets a filter for inclusion of transgenic animals, but the process described is the same regardless of specific filter selections.
Click the Add Agenda Filter button on the Set-up Agenda Categories page.
As shown below, the Set-up Agenda Filter page opens.
Click the Add Filter button. As shown below, an add panel is opened for creation of the new filter.
Click in the Filter Type field to open a dropdown picklist. Click “Filter User Defined” to select it.
An add panel is opened for configuration of a custom filter query.
As shown in the screenshot above, the What to Filter field in the query builder form defaults to “Applic. Form all columns”, and the corresponding Data Value fields default to What Application? and What Application Column?
In the screenshot below the What to Filter dropdown is expanded, showing that a second selection of “Submission Form all columns” is available.
When “Submission Form all columns” is selected the Data Value fields update to reflect options applicable to the Submission Form.
The What Form? dropdown list is populated with the names of forms configured for the specific institution, and the What Form Column? dropdown list is populated with items specific to the selected form.
Note that the overall process of creating a user defined filter is the same regardless of whether “Submission Form all columns” or “Applic. Form all columns” is selected under What to Filter. The user selects the desired submission / application form, then selects a specific field from that form to compare against in the query.
With the default selection of “Applic. Form all columns” in place, the What Application? dropdown list populates with application types. Click an application type in the list to select it.
As shown below, the What Application Column? dropdown list automatically populates with sections and questions applicable to the selected application.
Click the desired item in the What Application Column? dropdown list to select it. As shown below, the area beneath the What Application Column? field populates with options applicable to the selected column item.
A thorough knowledge of iRIS™ data tables is required to understand the auto-populated options provided.
Make desired selections in the area beneath the What Application Column? field, then select the desired comparator and data type from the dropdown lists at the lower left of the panel.
As shown below, the comparator dropdown contains all standard SQL query comparators. It is up to the user constructing the query to select a comparator type that is applicable to the selected Application Column value to the right of the comparator field.
Comparators of “NOT EQUAL” or “EQUAL” can be used for comparisons against Yes/No and text fields. The remaining comparators are used for comparisons against numeric values.
In this example a comparator of “EQUAL” is selected because the Application Column value can only be “Yes” or “No”.
Note that the second comparator field defaults to “Value” but will dynamically update with other options where such options are applicable to Application Column and comparator selections.
In the screenshot above the first clause of the user defined filter query is complete. This query returns applications where “No” is selected for option 1 of the question about whether transgenic animals are to be used in the study.
Note that when a configured filter is applied during creation of an Agenda Category, the user is prompted to choose whether to include or exclude records matching the filter’s criteria.
Click the Add a new Clause button to add another filter configuration panel to the page, adding another clause to the filter query.
When the query includes two or more clauses the Join by, if any field is used to specify the join type and the Order field is used to specify the order in which each clause is to be evaluated when the query runs.
SQL familiarity is required to correctly configure the Order and Join by, if any fields.
After all desired clauses have been configured for the query, enter a Filter Name and click the Save All Changes button to save the filter.
The filter is added on the Set-up Agenda Filter page.
Add Agenda Category
Where the property rb.use_meeting is set to “Yes” (accessed via IRB Assistant > Review Board Administration > [System Setup tab] > Board Configuration Options > Submission Review Properties link), the iRIS™ system provides the ability to configure a list of agenda topic categories. The configured list appears on the Meeting Agenda page, as shown below.
Navigate to IRB Assistant > Review Board Administration > [System Setup tab] > Setup Agenda Categories link.
The Set-up Agenda Categories page opens, as shown below.
Click the Add Group button. An add panel is opened for creation of the new category.
Complete the top of the add panel as follows:
— Group Name: enter a descriptive name for the category; recall that categories are used when creating a finalized agenda document template, so the name entered here should indicate the contents of the category
— Group Order: the entry in this field is shown in the Group Display Order column of the Set-up Agenda Categories page, and dictates the order in which this category appears in the finalized agenda document template
— Group Merge Code: enter the desired merge code to be used for inclusion of this category on forms and in document templates; note that the code must include underscores where spaces occur between words, and cannot include any special characters (e.g., &, #, etc.)
See the Using Merge Codes in Document Templates section of this manual for more information about working with merge codes.
An example of the filled fields is shown below. Click the Add button to attach forms to this category, if applicable.
The Select Review Board Forms popup appears, populated with all available forms for selection. Note that because forms are custom configured for each institution, the list of forms shown here will vary.
Click the Cancel button to close the popup without adding any forms to the category.
Select the checkbox(es) in the far-left column for forms to be attached to the category, then click the Select button.
The selected form(s) is(are) added to the category add panel, with options to apply previously configured filters for each form if desired. All previously configured filters are shown here.
See the Agenda Filter section of this manual for more information about filter configuration.
To remove any forms added to the category in error, select the checkbox(es) in the far-left column (shown in screenshot above) for forms to be deleted, then click the Remove button to remove the selected form(s).
In the screenshot below, the dropdown list containing options for application of the “Expedited Filter” on the “Arc Order Form” item is expanded. This dropdown list is the same for all filters.
Make all desired selections in the filter option dropdown lists, then click the Save All Changes button. Note that a selection is required in every dropdown list in order to save the category.
The category is added on the Set-up Agenda Categories page.
Edit Agenda Category
Navigate to IRB Assistant > Review Board Administration > [System Setup tab] > Setup Agenda Categories link.
The Set-up Agenda Categories page opens, as shown below.
Click the icon in the Edit column for the applicable category. The category is opened for editing.
Make any desired changes to fields at the top of the edit panel as follows:
— Group Name: descriptive name for the category; recall that categories are used when creating a finalized agenda document template, so the name entered here should indicate the contents of the category
— Group Order: the entry in this field is shown in the Group Display Order column of the Set-up Agenda Categories page, and dictates the order in which this category appears in the finalized agenda document template
— Group Merge Code: enter the desired merge code to be used for inclusion of this category on forms and in document templates; note that the code must include underscores where spaces occur between words, and special characters (e.g., &, #, etc.) are not allowed
See the Using Merge Codes in Document Templates section of this manual for more information about working with merge codes.
As shown in the screenshot below, select the checkbox(es) in the far-left column for any forms to be removed from the category, then click the Remove button to remove the selected form(s).
Click the Add button to attach forms to this category, if applicable. The Select Review Board Forms popup appears, populated with all available forms for selection. Note that because forms are custom configured for each institution, the list of forms shown here will vary.
Click the Cancel button to close the popup without adding any forms to the category.
Select the checkbox(es) in the far-left column for forms to be attached to the category, then click the Select button.
Any selected form(s) is(are) added to the category add panel, with options to apply previously configured filters for each form if desired. All previously configured filters are shown here.
See the Agenda Filter section of this manual for more information about filter configuration.
When all desired changes to the category are complete, click the Save All Changes button to save changes and close the edit panel.
Delete Agenda Category
Navigate to IRB Assistant > Review Board Administration > [System Setup tab] > Setup Agenda Categories link.
The Set-up Agenda Categories page opens, as shown below.
Select the checkbox in the far-left column for the applicable category(ies), then click the Delete Group(s) button. A confirmation popup window displays.
Click CANCEL to return to the Set-up Agenda Categories page without deleting the category(ies).
Click CONFIRM to delete the category(ies) and return to the Set-up Agenda Categories page. The category is deleted.
Setup Invoice Type
Invoice Types are configured on the Setup Invoice Type page. To access the page, navigate to IRB Assistant > Review Board Administration > [System Setup tab] > Setup Invoice Type link.
The Setup Invoice Type page opens.
Add Invoice Type
Navigate to IRB Assistant > Review Board Administration > [System Setup tab] > Setup Invoice Type link.
The Setup Invoice Type page opens. Click the Add a New Invoice Type button.
An add panel is opened for creation of the new record.
Enter an Invoice Type and click the Save Invoice Type button to save the record. The record is added on the Setup Invoice Type page.
Edit Invoice Type
Navigate to IRB Assistant > Review Board Administration > [System Setup tab] > Setup Invoice Type link.
The Setup Invoice Type page opens. Click the icon in the Edit column for the applicable record.
The record is opened in an edit panel.
Make desired changes to the Invoice Type and click the Save Invoice Type button to save the record. The record is revised on the Setup Invoice Type page.
Delete Invoice Type
Navigate to IRB Assistant > Review Board Administration > [System Setup tab] > Setup Invoice Type link.
The Setup Invoice Type page opens. Select the checkbox(es) in the far-left column for the record(s) to be deleted, then click the Delete Invoice Type(s) button.
A confirmation popup window displays.
Click CANCEL to close the popup without deleting the record.
Click CONFIRM to delete the record and close the popup. The Invoice Type is deleted on the Setup Invoice Type page.
Document Templates
The iRIS™ system provides tools for creation of pre-formatted document templates that include commonly used boilerplate text and can pull a variety of system data into a document on the fly, when a document is generated.
The general process for template setup and use is the same, regardless of the document or correspondence type.
— Template Definition: a template containing standardized boilerplate text for the desired document or correspondence type (e.g., meeting agenda, meeting minutes, vendor email, outcome letter, etc.) is created and formatted in a rich text editor
— Merge Code Addition: where the document or correspondence type needs to include specific data pulled from the iRIS™ system (e.g., order number, review board name, vendor email address, quantity of animals ordered, etc.), the applicable Merge Code for each needed data item is added to the template
— Document / Correspondence Generation: when a template-based document / correspondence is generated by an iRIS™ user, the pre-formatted template serves as the default starting point for the document / correspondence; the user edits the document / correspondence as desired before printing or sending it
The use of templates reduces time and effort demands on the user, reduces user error, and streamlines enforcement of institutional communication standards and policies.
Using Merge Codes in Document Templates
To insert a Merge Code in a document template, place the cursor in the text editor where the corresponding data value is to appear, then click the Insert Merge Code button to open the Merge Codes picklist.
Note that the example shown is taken from the Vivarium/ARC module, but the general process described is the same regardless of the module in use.
The Insert Data Merge Code popup window displays. Scroll down to the sections of the list labeled for ARC and select the desired Merge Code. In this example, the Merge Code for “Order Number” is selected.
Note that the list also includes sections for other modules, such as IACUC, to use in templates for documents applicable to those modules. See the Merge Code List subsection of this manual for more information.
Click the Cancel button to close the popup without inserting the Merge Code.
Click the OK button to insert the Merge Code. The selected Merge Code is inserted in the template at the cursor location.
In the screenshot below, Merge Codes for “Vendor Name”, “Order Number”, “Date Received”, “Order - Number of Females”, “Order - Number of Males”, “Receive – Number of Females”, “Receive – Number of Males”, and “Order – Order Date” are inserted.
Click the Save Template button to save changes.
Merge Code List
Depending on the user’s data access rights and the institution’s Review Board Administration settings, the Merge Code list can include system data from the following categories:
| Review Board | Study Financial Information |
| Meetings | Submission Information |
| Multi-Site | ARC Request Information |
| Study Personnel | ARC Ordering Information |
| Study Contacts | ARC Receiving Information |
| Form Creator | ARC Cage Information |
| Department Reviewer and Signoff | Study/IRB/IACUC Application Information |
Most of the Merge Codes in the picklist are grouped under category titles. As shown in the screenshot below, category titles are offset by dashed lines. Selectable Merge Code items are indicated by blue boxes.
Category titles are not Merge Codes and cannot be inserted in a template. If a title item is selected and the OK button is clicked, an error popup window displays.
Merge Codes Applicable to Animal Resource Center (ARC)
Categories and Merge Codes from the list that are most applicable to ARC are summarized in the table below.
| ---ARC Request Info --- | ---ARC Ordering Info --- | ---ARC Receiving Info --- | ---ARC Cage Info --- |
|---|---|---|---|
| Number of Females | Order - Order Date | Date Received | Cage Type |
| Number of Males | Expected Delivery Date | Purchase Cost | Bar Code |
| Age Size | Confirmation Number | Service Cost | Cage - Cage ID |
| Species Name | Method of Ordering | Container OK | Cage - Species |
| Strain Name | Vendor Name | General Appearance | Cage - Strain |
| Order Number | Vendor Contact | Eyes, Ears, Nose, Mouth | Cage - Number of Males |
| Request - Order Date | Vendor Phone | Urogenital, Anus | Cage - Number of Females |
| Preferred Delivery Date | Vendor Fax | Respiratory | Cage - Number of Unknown Sex |
| Preferred Vendor | Vendor Email | Hydration | Cage - Cage Card Comments |
| Request - Stock Number/Code | Order - Species | Receive - Number of Males | Cage - List of Animal IDs |
| Request - Age/Size | Order - Strain | Receive - Number of Females | |
| Request - Number of Males | Order - Stock Number/Code | Must go through Quarantine | |
| Request - Number of Females | Order - Age/Size | Receive - Number of Cages | |
| Request - Number of Cages | Order - Number of Males | Receive - Approved Location | |
| Request - Approved Location | Order - Number of Females | ||
| Order - Number of Cages | |||
| Order - Approved Location |
Merge Codes Applicable to Meetings
Categories and Merge Codes from the list that are most applicable to meetings are summarized in the table below.
| ---Review Board Info --- | ---Meeting Attendance Codes --- | ---Submission Info --- |
|---|---|---|
| Review Board Name | Meeting Call to Order | Submission Approval Date |
| Review Board Committee Name | Meeting New Business | Submission Type |
| Chairperson Name (Last Name, First Name) | Meeting Old Business | Submission List of all reviewers |
| Chairperson Name (First Name, Last Name) | Meeting Miscellaneous | Submission Primary Reviewer |
| Chairperson First Name | Meeting Closing Comments | Submission Secondary Reviewer |
| Chairperson Middle Name | Meeting Actual Start Time | Submission all additional reviewers over secondary |
| Chairperson Last Name | Meeting Actual End Time | Submission AD Hoc Reviewers |
| Chairperson Degree | Meeting Planned Start Time | Item Number on Agenda |
| Chairperson Address | Meeting Planned End Time | All Project Departments |
| Chairperson Phone | Meeting Chair (Last, First) | All Project Institutions |
| Chairperson EMAIL | Meeting Chair (First, Last) | Project Title |
| Electronic Signature | Total Voting Members | Project Short Title |
| Meeting Date | Quorum | Project Status |
| Meeting Location | Voting Members Present | Study Title |
| Non-Voting Members Present | Study Alias | |
| Alternate Members Present | Study Status | |
| Members Absent | Sponsor/Funding Source | |
| Member Ex-officio Present | Proposal Number | |
| Administrative Staff Present | Proposal Title | |
| Guests Present | Proposal Short Title | |
| Meeting Motions | Project Award Number | |
| Project Previous Award Number | ||
| Project Open Ended | ||
| Is Archived | ||
| Archived Location |
Setup Consent Template
Review board Consent templates provide the ability to upload consent templates or edit existing templates for use by researchers when building their informed consent document(s). Consent templates are configured on the Setup Consent Template page, which is accessed via IRB Assistant > Review Board Administration > [System Setup tab] > Setup Consent Template link (shown below).
Previously configured document templates are listed on the Setup Consent Template page.
Click the icon in the View File column (red box in screenshot above) to view a read-only version of the corresponding template in a new tab or window of the browser.
Any templates configured on the Setup Consent Template page are made available to users when an Informed Consent is added to a study, as shown below.
Add Consent Template
Navigate to IRB Assistant > Review Board Administration > [System Setup tab] > Setup Consent Template link (shown below).
The Setup Consent Template page opens (shown below).
Click the Add a New Template button (red box in screenshot above). A text editor panel (shown below) opens for creation of the template.
Complete the fields in the text editor panel as follows:
Title — enter the title of the consent template in the text box
Comments —enter any desired comments
Shared —select this box to share this Consent template with other review boards that use Consent documents
Text Editor — enter desired text and Merge Codes; see the Using Merge Codes in Document Templates section of this manual for more information about working with Merge Codes
When all fields are complete, click the Save the Template button to save changes and close the text editor panel.
The template is added to the list on the main Setup Consent Template page, and is made available to users for selection when an Informed Consent is added to a study.
Check Out Template for Offline Revision
iRIS™ provides the option to create a Consent template file in the iRIS™ system, download the file for offline revision, and finally upload the revised document back into the system. This is a useful option in cases where extensive revisions are required, or where more sophisticated text editor tools are needed than those provided in the system.
Navigate to IRB Assistant > Review Board Administration > System Setup Tab > Setup Consent Template link (shown below).
The Setup Consent Template page opens (shown below).
To create a new template file for offline revision, click the Add a New Template button (red box in screenshot above). A text editor panel (shown below) opens for creation of the template.
Complete the fields in the text editor panel as follows:
Title — enter the title of the consent template in the text box
Comments —enter any desired comments about this template
Shared —select this box to share this Consent template with other review boards that use Consent documents
Text Editor — enter placeholder text or leave blank; recall that the file will be revised offline
Click the Check In/Out tab (blue arrow in screenshot below) to download the template file. As shown below, the Check In/Out tab is opened and the HTML Content tab (red arrow below) is deselected.
As per the instructions provided on this tab, click the Download Document button to download a copy of the letter template in RTF format. The Download the RB Template Consent Content page opens, as shown below.
IMPORTANT: READ AND FOLLOW THE DIRECTIONS PROVIDED ON THE PAGE TO ENSURE UPLOAD OF THE REVISED DOCUMENT WILL BE ENABLED. See items boxed in red in the screenshot above.
Make desired changes to the downloaded copy of the letter template in any rich text editor and save the file under the same name as the original download.
Return to the Setup Consent Template page and click the icon in the Edit column (red box in screenshot below) for the applicable template.
The template opens in the HTML Content tab of the text editor panel by default. Select the Check In/Out tab (shown below) and click the Upload Document button.
An Add User Document popup opens, as shown below.
Follow the directions in the popup to navigate to the revised file on the local computer and upload it to the iRIS™ system. As shown below, a countdown popup briefly appears as the upload is processed.
When the popup closes, back in the text editor panel of the Setup Consent Template page, click the Save the Template button to save changes and close the edit panel.
The template is added to the list on the main Setup Consent Template page, and is made available to users for selection when an Informed Consent is added to a study.
Edit Consent Template
Navigate to IRB Assistant > Review Board Administration > [System Setup tab] > Setup Consent Template link (shown below).
The Setup Consent Template page opens (shown below).
Click the applicable icon in the Edit column. The selected template opens in a text editor panel (shown below) for revision.
Make desired changes in the upper section of the text editor panel. Fields in that section are as follows:
Title — title of the consent template in the text box
Comments — comments about this template
Shared — select this box to share this Consent template with other review boards that use Consent documents
Text Editor — current template content, which may include Merge Codes; see the Using Merge Codes in Document Templates section of this manual for more information about working with Merge Codes
When all field revisions are complete, click the Save the Template button to save changes and close the text editor panel.
The revised template remains in the list on the main Setup Consent Template page, and is made available to users for selection when an Informed Consent is added to a study.
Check Out Template for Offline Revision
iRIS™ provides the option to download a Consent template file from the iRIS™ system for offline revision. This is a useful option in cases where extensive revisions are required, or where more sophisticated text editor tools are needed than those provided in the system.
Navigate to IRB Assistant > Review Board Administration > System Setup Tab > Setup Consent Template link (shown below).
The Setup Consent Template page opens (shown below).
Click the applicable icon in the Edit column. The selected template opens in a text editor panel (shown below) for editing.
Make desired changes in the upper section of the text editor panel. Fields in that section are as follows:
Title — title of the consent template in the text box
Comments — comments about this template
Shared — select this box to share this Consent template with other review boards that use Consent documents
Text Editor — current template content
Click the Check In/Out tab (blue arrow in screenshot below) to download the template file. As shown below, the Check In/Out tab is opened and the HTML Content tab (red arrow below) is deselected.
As per the instructions provided on this tab, click the Download Document button to download a copy of the letter template in RTF format. The Download the RB Template Consent Content page opens, as shown below.
IMPORTANT: READ AND FOLLOW THE DIRECTIONS PROVIDED ON THE PAGE TO ENSURE UPLOAD OF THE REVISED DOCUMENT WILL BE ENABLED. See items boxed in red in the screenshot above.
Make desired changes to the downloaded copy of the letter template in any rich text editor and save the file under the same name as the original download.
Return to the Setup Consent Template page and click the icon in the Edit column (red box in screenshot below) for the applicable template.
The template opens in the HTML Content tab of the text editor panel by default. Select the Check In/Out tab (shown below) and click the Upload Document button.
An Add User Document popup opens, as shown below.
Follow the directions in the popup to navigate to the revised file on the local computer and upload it to the iRIS™ system. As shown below, a countdown popup briefly appears as the upload is processed.
When the popup closes, back in the text editor panel of the Setup Consent Template page, click the Save the Template button to save changes and close the edit panel.
The template remains in the list on the main Setup Consent Template page, and is made available to users for selection when an Informed Consent is added to a study.
Delete Consent Template
Navigate to IRB Assistant > Review Board Administration > [System Setup tab] > Setup Consent Template link (shown below).
The Setup Consent Template page opens (shown below).
Select the checkbox(es) in the far left column for the template(s) to be deleted and click the Delete Selected Template(s) button. A confirmation popup displays.
Click the CANCEL button to return to the Setup Consent Template page without deleting the selected template(s).
Click the CONFIRM button to confirm the deletion and return to the Setup Consent Template page.
Setup Consent Builder Template
A Consent Builder Template is a document designed to step users through the process of customizing the consent form. Consent templates are configured on the Setup Consent Template page, which is accessed via IRB Assistant > Review Board Administration > [System Setup tab] > Setup Consent Builder Template link (shown below).
Previously configured Consent Builder templates are listed on the Setup Core Consent Template page.
Any templates configured on the Setup Core Consent Template page are made available to users when an Informed Consent is added to a study, as shown below.
Add Consent Builder Template
Navigate to IRB Assistant > Review Board Administration > [System Setup tab] > Setup Consent Builder Template link (shown below).
The Setup Core Consent Template page opens (shown below).
Click the Add a New Template Master button (red box in screenshot above). The Edit a consent builder template document panel opens, as shown below.
Enter a Name for the template and click the Click here to add the consent builder template link to proceed. The IRB – Consent Master Template Editor page opens, as shown below.
Enter desired text and Merge Codes in the text editor, and apply any desired formatting. See the Using Merge Codes in Document Templates section of this manual for more information about working with Merge Codes.
Recall that this type of template is intended to step the user through the process of customizing the Consent form, and should include instructions to the user.
When template content is complete, click the Save Change button (red box in screenshot above) to save the contents of the text editor and close it. Click the Save Template button in the Edit a consent builder template document panel (shown below).
The template is added to the list on the Setup Core Consent Template page.
Edit Consent Builder Template
Navigate to IRB Assistant > Review Board Administration > [System Setup tab] > Setup Consent Builder Template link (shown below).
The Setup Core Consent Template page opens (shown below).
Click the applicable icon in the Edit column (red box in screenshot above) to open the corresponding template for revision. The Edit a consent builder template document panel opens, as shown below.
Make desired changes to the template Name.
If no further changes are needed click the Save Template button (red box in screenshot above) to save changes and close the edit panel. The template name is revised on the Setup Core Consent Template list page.
To revise the contents of the template, click the Click here to add the consent builder template link. The template is opened in the IRB – Consent Master Template Editor page opens, as shown below.
Make desired changes to the text and Merge Codes in the text editor, and apply any desired formatting. See the Using Merge Codes in Document Templates section of this manual for more information about working with Merge Codes.
When template changes are complete, click the Save Change button (red box in screenshot above) to save the contents of the text editor and close it. Click the Save Template button in the Edit a consent builder template document panel (shown below).
The template is revised in the list on the Setup Core Consent Template page.
Delete Consent Builder Template
Navigate to IRB Assistant > Review Board Administration > [System Setup tab] > Setup Consent Builder Template link (shown below).
The Setup Core Consent Template page opens (shown below).
Select the checkbox(es) in the far left column for the template(s) to be deleted and click the Delete Selected Template(s) button. A confirmation popup displays.
Click the CANCEL button to return to the Setup Core Consent Template page without deleting the selected template(s).
Click the CONFIRM button to confirm the deletion and return to the Setup Core Consent Template page.
Setup Bundle Email Template
Where the property rb.use_bundle_stipulation is set to “Yes” (accessed via IRB Assistant > Review Board Administration > Board Configuration Options > Recommendations and Stipulations link), documents selected in the Submission Complete tab of a completed submission are bundled with an electronic cover letter for routing to selected recipients.
Navigate to IRB Assistant > Review Board Administration > [System Setup tab] > Setup Bundle Email Template link to configure the electronic cover letter.
The RB Bundle Template page opens. Notice that by default, once the applicable property is set to “Yes” an unconfigured “RB Bundle Document Template” is created, with Title and Send E-Mail Notification fields set to “Not Defined”.
Note that only one RB Bundle Template can be configured at any time, and once configured, that template is applied to all applicable email bundles.
Click the Add Notification button. The Edit RB Bundle Template page opens, as shown below.
Complete the page fields as follows.
E-mail Subject —subject line of the email bundle cover letter
Send E-mail Notification — select “Yes” to enable document bundling with the configured cover letter; select “No” to save the configured cover letter to the system without enabling document bundling
Recipient(s) — click the word Recipient(s) to add iRIS™ users to the distribution list
As shown below, the Search User Directory page opens.
Click in the by Department field to open a dropdown list of departments, then click a department in the list to add this criterion to the search. Note that it is not possible to search by department alone, full or partial Last Name / First Name entries are also required.
Enter a full or partial Last Name and/or First Name to search by name. As shown below, the Last Name field offers a dynamic picklist feature that populates as the Last Name is typed into the field.
As demonstrated below, clicking on a name shown in the dynamic Last Name picklist immediately populates search results with details for that name, it is not necessary to click the Find button.
When all search criteria are entered, if results are not yet populated click the Find button.
As indicated below, the results section of the page offers two methods for adding users to the distribution list.
To add multiple users from a results list with multiple entries, select the Check for Multiple checkbox at far left (blue arrow) for each user to be added, then click the Save Selected User(s) button at the upper right (blue box).
To add a single user from the results list, click the green checkmark for the applicable user (red arrow).
When the applicable user(s) is(are) selected from the Search User Directory page, that page closes and the name(s) is(are) added to the Recipient(s) list as shown below. To add more iRIS™ users to the list, click the word Recipient(s) again and repeat the user lookup/add process.
If any Recipient(s) were added in error select the checkbox to the left of the applicable name and click the Delete button to delete it, as shown below.
Additional recipient(s) — click the words “Additional recipient(s)” to add people who do not have an iRIS™ account to the distribution list
The Recipient Additional Contacts page opens, as shown below.
Click the Add A New Contact link to add a blank row to the Additional Recipients table, as shown below.
Enter the contact Name and E-mail Address. Click the Add a New Contact button again and enter Name/E-mail Address details for every non-iRIS™ user to be added to the distribution list, as shown below.
If any rows are added in error, select the checkbox in the far-left column for the applicable name and click the Remove Selected Contacts button (red boxes in screenshot above).
When all desired contacts are entered click the Save And Return button (blue box in screenshot above) to close the Recipient Additional Contacts page and add the listed contacts to the distribution list on the Edit RB Bundle Template page, as shown below.
If any Additional recipient(s) are added in error, click the words Additional recipient(s) again to reopen the Recipient Additional Contacts form and delete the applicable contact(s).
Content — enter desired text and Merge Codes (see Using Merge Codes in Document Templates subsection of this manual for more information about working with Merge Codes) for the bundle cover letter; use the provided toolbar to format the text as desired
An example of a fully configured template is shown below. Click the Save Notification button to save the template and close the Edit RB Bundle Template page.
As shown below, the template is now configured on the RB Bundle Template page.
Notice that an Edit icon (red box in the screenshot above) is now available and the Add Notification button is now replaced with a Delete Notification button (blue box in the screenshot above), indicating that only one version of the template can be configured at any time.
Click the icon in the Edit column to reopen the template for revision in the Edit RB Bundle Template page.
Click the Delete Notification button to delete the configured template and disable document bundling with a configured cover letter.
CAUTION: this action cannot be undone. If it later becomes necessary to resume document bundling the RB Bundle Template must be reconfigured according to the directions in this section.
With the configured template in place, when a submission is completed and saved the option to Send Bundle Email is made available via a button, as shown below.
Clicking the Send Bundle Email button creates an email cover letter with all text, recipients and Merge Code data items as configured in the template. All configured items can be revised in this email cover letter prior to sending.
When the bundle email is sent, all documents selected in the Submission Complete tab of the applicable submission are bundled and sent to the specified recipients.
Setup Finalized Agenda Document Template
The iRIS™ system provides the ability to configure finalized meeting agenda templates that include commonly used boilerplate text and can automatically pull a variety of system data into the agenda when it is generated.
This functionality is provided on the Finalized Agenda Templates page. To access the page, navigate to IRB Assistant > Review Board Administration > [System Setup tab] > Setup Finalized Agenda Document Template link.
The Finalized Agenda Templates page opens, as shown below. Notice the two instruction items and the corresponding buttons for each.
As indicated in the instructions, the first step is setting up the Agenda Template Master. Click the Setup Agenda Template button to begin.
The Agenda Template Definition text editor page opens, as shown below.
Enter desired boilerplate text and Merge Codes and apply formatting as desired using the provided rich text editor toolbar. See the Using Merge Codes in Document Templates section of this manual for more information about working with Merge Codes.
Recall that this template serves as the basis for all finalized agenda documents, and therefore it should include all items considered standard and necessary to any finalized agenda. An example of a completed finalized agenda template is shown below.
When template content is complete, click the Save Change button to close the page and save the template.
Back on the Finalized Agenda Templates page, any previously configured, custom agenda category sections are listed in the lower section of the screen. Each section can be configured to specify what information is to be displayed for each submission in the agenda template master.
Note that custom agenda category configuration includes a study/protocol/project selection component that automatically limits review items pulled into the meeting to those matching specific criteria. Adding a custom category to the agenda does not pull all animal study/protocol/project items into the meeting.
See the Setup Agenda Categories section of this manual for more information about configuration of custom agenda categories.
Again, recall that the template serves as the basis for all finalized agenda documents; custom agenda categories should only be added to the template if those categories are applicable to most meeting agendas.
Click the Setup Section Information button for any agenda category to be added to the finalized agenda template. The Agenda Section Definition page opens, as shown below.
The boilerplate text and Merge Codes entered here depend on the purpose of the agenda category. In this example the category is intended to add animal issue reporting to the meeting, so its content is focused on changes in animal life status and population counts. An example of a completed section definition is shown below.
When section definition content is complete, click the Save Change button to close the page and save the section definition.
Going forward, each IRB Meeting Agenda generated for a specific meeting date will consist of one document that includes both the Agenda Template Master and any custom sections configured as above.
See the Meetings manual for more information about meeting management functionality in iRIS™.
Setup Agenda Revision Document Template
The Revision Agenda Template is used to generate an addendum when a new submission is placed on the agenda after the initial Agenda is published for a given meeting date.
This functionality is provided on the Finalized Agenda Templates page. To access the page, navigate to IRB Assistant > Review Board Administration > [System Setup tab] > Setup Agenda Revision Document Template link.
The Setup Board Agenda Revision Templates page opens, as shown below.
Notice that this page is nearly identical to the Finalized Agenda Templates page, with the exception that where the Finalized Agenda Templates page is used to configure the Agenda Template Master, this page is used to configure the Revision Template Master.
Where this feature is in use it is often necessary for the institution to configure applicable agenda categories to capture the most common agenda revision scenarios and related, pertinent data. See the Setup Agenda Categories section of this manual for more information about configuration of custom agenda categories.
The process of configuring the Revision Template Master is the same as that for configuration of the Agenda Template Master. See the Setup Finalized Agenda Document Template section of this manual for details of template configuration.
Setup Expedite Report Template
Where the property rb.use_meeting is set to “Yes” (accessed via IRB Assistant > Review Board Administration > System Setup tab > Board Configuration Options > Meeting Settings link), it is possible to generate a summary of expedited reports for attachment to a meeting date.
This functionality is provided on the Setup Expedite Report Templates page. To access the page, navigate to IRB Assistant > Review Board Administration > [System Setup tab] > Setup Expedite Report Template link.
The Setup Expedite Report Templates page opens, as shown below.
Click the Setup Template button. The Expedite Report Template Definition text editor page opens, as shown below.
Enter desired boilerplate text and Merge Codes and apply formatting as desired using the provided rich text editor toolbar. See the Using Merge Codes in Document Templates section of this manual for more information about working with Merge Codes.
An example of a completed expedite report template is shown below.
When template content is complete, click the Save Change button to close the page and save the template.
See the Meetings manual for more information about generation of the expedited report as it relates to meeting functionality in iRIS™.
Setup Meeting Minutes Template
The Meeting Minutes Template is used to generate a standardized minutes document for a given meeting date.
This functionality is provided on the Setup Board Minute Templates page. To access the page, navigate to IRB Assistant > Review Board Administration > [System Setup tab] > Setup Meeting Minutes Template link.
The Setup Board Minute Templates page opens, as shown below.
Notice that this page is nearly identical to the Finalized Agenda Templates page, with the exception that where the Finalized Agenda Templates page is used to configure the Agenda Template Master, this page is used to configure the Minutes Template Master.
The process of configuring the Minutes Template Master is the same as that for configuration of the Agenda Template Master. See the Setup Finalized Agenda Document Template section of this manual for details of template configuration.
Setup Outcome Letter Groups
The iRIS™ system allows for collecting sets of review board forms into custom configured Letter Type groups for assignment to different board review types. As shown below, the Letter Types list on the add/edit panel of the Setup Board Letter Templates page (see the Setup Outcome Letter Templates section of this manual) includes two default entries:
— Outcome - General: letter templates of this type appear as options available for selection on the Outcome Letter tab of submission processing screens
Note: filters assigned to custom outcome letter groups determine those groups’ availability in the dropdown list on the Outcome Letter tab, but the Outcome – General Group is always be available. For example, a letter associated to a group called “Outcome – Full Renewal Approval” that has a filter assigning that group to the Full Renewal Submission type would only be available for a Full Renewal Submission type, this letter would not be available for any other submission type.
— Submission: letter templates of this type appear as options available for selection on the Submission Received Notification Letter tab of submission processing screens (IACUC example shown below)
Custom configured Letter Type groups are added to the Letter Type dropdown list on the Setup Board Letter Templates page (shown in the first screenshot above), and are optionally made available on the Outcome Letter tab of submission processing screens according to rules established at the time a Letter Type group is created or revised (see Add Outcome Letter Group and Edit Outcome Letter Group subsections of this manual, below).
Letter Type groups are configured on the Setup Board Letter Group List page, shown below.
Add Outcome Letter Group
Navigate to IRB Assistant > Review Board Administration > [System Setup tab] > Setup Outcome Letter Groups link.
The Setup Board Letter Group List page opens. Click the Add Group button.
An add panel is opened for creation of the group. Enter the desired Group Name, as shown below, then click the Add button at right.
A popup opens for selection of review board forms to be included in the group. Note that because forms are custom configured for each institution, the list of forms shown here will vary.
Click the Cancel button to close the popup without adding any forms to the group.
Select the checkbox(es) in the far-left column for all forms to be included in the group, then click the Select button to add them to the group and close the popup. As shown below, the selected forms are added to the list of forms on the add panel.
If any forms were selected from the popup list in error, select the checkbox(es) for any forms to be removed from the group and click the Remove button.
Select or de-select the applicable checkboxes to make each form listed available/unavailable as part of the group according to board review type when the group is selected in the Notification Letter dropdown list in the Outcome Letter section of submission processing screens (shown below).
Note that all forms in the group are made available to the Full Board Review type by default.
An example of the fully configured group is shown in the screenshot below.
Click the Save All Changes button to save the new group. As shown below, the group is added on the Setup Board Letter Group List page.
The new Letter Type group is also added to the Letter Type dropdown list on the Setup Board Letter Templates page and is made available on the Outcome Letter tab of submission processing screens for Expedite, Exempt and Process Administratively board review types.
Edit Outcome Letter Group
Navigate to IRB Assistant > Review Board Administration > [System Setup tab] > Setup Outcome Letter Groups link.
The Setup Board Letter Group List page opens. Click icon in the Edit column for the applicable group.
The group is opened for editing. Make any desired changes to the Group Name.
To remove forms from the group, select the applicable checkbox(es) in the far-left column and click the Remove button.
Select or de-select the applicable checkboxes to make each form listed available/unavailable as part of the group according to board review type when the group is selected in the Notification Letter dropdown list in the Outcome Letter section of submission processing screens (shown below).
Note that all forms in the group are made available to the Full Board Review type by default.
In the example screenshot below, checkboxes for the Expedite board review type are de-selected. Applying this change means that the forms shown will not be included in the IRB Correction Forms group when it is selected from the Notification Letter dropdown list (see screenshot above) for submissions assigned to the Exempt board review type.
Click the Save All Changes button to save changes and close the edit panel.
Delete Outcome Letter Group
Navigate to IRB Assistant > Review Board Administration > [System Setup tab] > Setup Outcome Letter Groups link.
The Setup Board Letter Group List page opens. Select the checkbox(es) for the group(s) to be deleted and click the Delete Group(s) button.
A confirmation popup displays.
Click the CANCEL button to return to the Setup Board Letter Group List page without deleting the selected template(s).
Click the CONFIRM button to confirm the deletion and return to the Setup Board Letter Group List page.
Setup Outcome Letter Templates
The iRIS™ system provides the ability to configure standardized outcome letter templates that include commonly used boilerplate text and can automatically pull a variety of system data into the letters when they are generated.
This functionality is provided on the Setup Board Letter Templates page. To access the page, navigate to IRB Assistant > Review Board Administration > [System Setup tab] > Setup Outcome Letter Templates link.
The Setup Board Letter Templates page opens, as shown below.
Add Outcome Letter Template
Navigate to IRB Assistant > Review Board Administration > [System Setup tab] > Setup Outcome Letter Templates link.
The Setup Board Letter Templates page opens, as shown below.
Click the Add a New Template button. As shown below, the Add a letter template panel opens for creation of the new letter.
Enter the desired Title and Comments, then click in the Letter Type field and click to select an item in the dropdown list. As shown below, the list includes two default entries:
— Outcome - General: letter templates of this type appear as options available for selection on the Outcome Letter tab of submission processing screens
— Submission: letter templates of this type appear as options available for selection on the Submission Received Notification Letter tab of submission processing screens
Note that any letter types configured via the Setup Outcome Letter Groups function are added to the Letter Type dropdown list. When a custom configured letter type is selected, the associated letter template’s inclusion as an option available for selection on the Outcome Letter tab of submission processing screens is dictated by rules established when the Letter Group is created. See the Setup Outcome Letter Groups section of this manual for more information about configuring Letter Groups.
Enter desired text and Merge Codes in the main text editor window. See the Using Merge Codes in Document Templates section of this manual for more information about working with Merge Codes.
Apply any desired formatting, then click the Save the Letter Template button.
The template is added on the Setup Board Letter Templates page.
Edit Outcome Letter Template
Navigate to IRB Assistant > Review Board Administration > [System Setup tab] > Setup Outcome Letter Templates link.
The Setup Board Letter Templates page opens, as shown below. Click the icon in the Edit column for the applicable template.
As shown below, the template is opened for editing in an Edit a letter template panel.
Make desired changes to the Title, Comments and Letter Type fields. The Letter Type list includes two default entries:
— Outcome - General: letter templates of this type appear as options available for selection on the Outcome Letter tab of submission processing screens
— Submission: letter templates of this type appear as options available for selection on the Submission Received Notification Letter tab of submission processing screens
Note that any letter types configured via the Setup Outcome Letter Groups function are added to the Letter Type dropdown list. When a custom configured letter type is selected, the associated letter template’s inclusion as an option available for selection on the Outcome Letter tab of submission processing screens is dictated by rules established when the Letter Group is created. See the Setup Outcome Letter Groups section of this manual for more information about configuring Letter Groups.
The two tabs in the lower part of the edit panel offer two different methods for revising the template’s content.
As shown below, the HTML Content tab (red arrow and box) allows for direct editing in the text editor window.
When all desired revisions are complete using the HTML Content tab, click the Save the Letter Template button to save changes and close the edit panel.
Click the Check In/Out tab (blue arrow in screenshot above) to access the second editing method. As shown below, the Check In/Out tab is opened.
As per the instructions provided on this tab, click the Download Document button to download a copy of the letter template in RTF format. The Download the RB Template Letter Content page opens, as shown below.
IMPORTANT: READ AND FOLLOW THE DIRECTIONS PROVIDED ON THE PAGE TO ENSURE UPLOAD OF THE REVISED DOCUMENT WILL BE ENABLED. See items boxed in red in the screenshot above.
Make desired changes to the downloaded copy of the letter template in any rich text editor and save the file under the same name as the original download.
Return to the Setup Board Letter Templates page and click the icon in the Edit column for the applicable template. Select the Check In/Out tab (shown below) and click the Upload Document button.
An Add User Document popup opens, as shown below.
Follow the directions in the popup to navigate to the revised file on the local computer and upload it to the iRIS™ system. As shown below, a countdown popup briefly appears as the upload is processed.
When the popup closes, back in the Edit a letter template panel, click the Save the Letter Template button to save changes and close the edit panel.
Delete Outcome Letter Template
Navigate to IRB Assistant > Review Board Administration > [System Setup tab] > Setup Outcome Letter Templates link.
The Setup Board Letter Templates page opens, as shown below. Select the checkbox(es) in the far-left column for the template(s) to be deleted, then click the Delete Selected Template(s) button.
A confirmation popup displays.
Click the CANCEL button to return to the Setup Board Letter Templates page without deleting the selected template(s).
Click the CONFIRM button to confirm the deletion and return to the Setup Board Letter Templates page.
Setup Invoice Template
The iRIS™ system provides the ability to configure standardized invoice templates that include commonly used boilerplate text and can automatically pull a variety of system data into the letters when they are generated.
This functionality is provided on the Setup Board Invoice Templates List page. To access the page, navigate to IRB Assistant > Review Board Administration > [System Setup tab] > Setup Invoice Template link.
The Setup Board Invoice Templates List page opens, as shown below.
Add Invoice Template
Navigate to IRB Assistant > Review Board Administration > [System Setup tab] > Setup Invoice Template link.
The Setup Board Invoice Templates List page opens, as shown below.
Click the Add a New Template button. As shown below, the Add a Invoice template panel opens for creation of the new invoice.
Enter the desired Title and Comments, then click in the Invoice Type field and click to select an item in the dropdown list.
Note that any invoice types configured via the Setup Invoice Type function are added to the Invoice Type dropdown list. See the Setup Invoice Type section of this manual for more information about configuring Invoice Types.
Enter desired text and Merge Codes in the main text editor window, and apply any desired formatting. See the Using Merge Codes in Document Templates section of this manual for more information about working with Merge Codes.
When all fields and text editor content are complete, click the Save the Invoice Template button.
The template is added on the Setup Board Invoice Templates List page.
Edit Invoice Template
Navigate to IRB Assistant > Review Board Administration > [System Setup tab] > Setup Invoice Template link.
The Setup Board Invoice Templates List page opens, as shown below.
Click the icon in the Edit column for the applicable invoice template. As shown below, the template is opened for revision in an Edit a Invoice template panel.
Make desired changes to the Title, Comments and Invoice Type fields.
Note that any invoice types configured via the Setup Invoice Type function are added to the Invoice Type dropdown list. See the Setup Invoice Type section of this manual for more information about configuring Invoice Types.
Click the Save the Invoice Template button to save changes and close the edit panel.
Delete Invoice Template
Navigate to IRB Assistant > Review Board Administration > [System Setup tab] > Setup Invoice Template link.
The Setup Board Invoice Templates List page opens, as shown below. Select the checkbox(es) in the far-left column for the template(s) to be deleted, then click the Delete Selected Template(s) button.
A confirmation popup displays.
Click the CANCEL button to return to the Setup Board Invoice Templates List page without deleting the selected template(s).
Click the CONFIRM button to confirm the deletion and return to the Setup Board Invoice Templates List page.
Setup Correspondence Templates
The iRIS™ system provides the ability to configure standardized correspondence templates that include commonly used boilerplate text and can automatically pull a variety of system data into the correspondence when it is generated.
This functionality is provided on the Setup Board Correspondence Templates page. To access the page, navigate to IRB Assistant > Review Board Administration > [System Setup tab] > Setup Correspondence Template link.
The Setup Board Correspondence Templates page opens, as shown below.
Correspondence templates can be employed when creating a correspondence record within the submission processing screens. Configured templates are made available via a Template dropdown picklist above the embedded rich text editor.
The desired template is selected in the list and when the Import template button is clicked, the template’s content is pulled into the text editor.
Add Correspondence Template
Navigate to IRB Assistant > Review Board Administration > [System Setup tab] > Setup Correspondence Template link.
The Setup Board Correspondence Templates page opens, as shown below.
Click the Add Template button. As shown below, an add panel opens for creation of the correspondence.
Enter desired text and Merge Codes in the main text editor window. See the Using Merge Codes in Document Templates section of this manual for more information about working with Merge Codes.
Apply any desired formatting, then click the Save Template button. The template is added on the Setup Board Correspondence Templates page.
Edit Correspondence Template
Navigate to IRB Assistant > Review Board Administration > [System Setup tab] > Setup Correspondence Template link.
The Setup Board Correspondence Templates page opens, as shown below.
Click the icon in the Edit column for the applicable item. As shown below, the correspondence is opened in an edit panel. Make desired changes in the Title and Content fields.
See the Using Merge Codes in Document Templates section of this manual for more information about working with Merge Codes.
When all desired changes are complete, click the Save Template button. The template is revised on the Setup Board Correspondence Templates page.
Delete Correspondence Template
Navigate to IRB Assistant > Review Board Administration > [System Setup tab] > Setup Correspondence Template link.
The Setup Board Correspondence Templates page opens. Select the checkbox(es) in the far-left column for the template(s) to be deleted, then click the Delete Template button.
A confirmation popup window displays.
Click CANCEL to return to the Setup Board Correspondence Templates page without deleting the template(s).
Click CONFIRM to delete the item(s) and return to the Setup Board Correspondence Templates page. The template(s) is(are) deleted.
Setup Canned Motion
The iRIS™ system provides the ability for institutions to configure a list of predefined (“canned”) motions for use in review board meetings. There is no limit to the number of canned motions that can be configured in this list.
Any configured canned motion is added to the Precanned Motion text dropdown list on the Submission Motion page of the Vote tab in Submission processing screens.
To access the configuration list, navigate to IRB Assistant > Review Board Administration > [System Setup tab] > Setup Canned Motion link.
The Setup Canned Motion List page opens.
Any canned motion configured here is added to the Precanned Motion text dropdown list on the Vote tab of Submission processing screens.
Add Canned Motion
Navigate to IRB Assistant > Review Board Administration > [System Setup tab] > Setup Canned Motion link.
The Setup Canned Motion List page opens.
As shown below, an Add Canned Motion of submission item panel opens for configuration of the motion.
Enter the desired Name and Item Number. Item Number dictates the order in which canned motions appear on the Setup Canned Motion List page and in the Precanned Motion text dropdown list on the Vote tab of Submission processing screens.
Click the Click here to edit/view the motion text link to enter desired motion text.
As shown below, a Canned Motion text page with a text editor for creation and formatting of the motion text opens.
Enter desired motion text and apply any desired formatting, as shown above, then click the Save button.
As shown below, the text is added to the Add Canned Motion of submission item panel. Click the Save Motion button.
As shown below, the motion is added on the Setup Canned Motion List page.
Edit Canned Motion
Navigate to IRB Assistant > Review Board Administration > [System Setup tab] > Setup Canned Motion link.
The Setup Canned Motion List page opens. Click the icon in the Edit column for the applicable motion.
As shown below, an Edit Canned Motion of submission item panel opens for configuration of the motion.
Revise the Name and Item Number fields as desired. Item Number dictates the order in which canned motions appear on the Setup Canned Motion List page and in the Precanned Motion text dropdown list on the Vote tab of Submission processing screens.
Click the Click here to edit/view the motion text link to revise the motion text. As shown below, the motion is opened in a Canned Motion text page with a text editor for revision and formatting of the motion text.
When changes are complete click the Save button. As shown below, the text is added to the Edit Canned Motion of submission item panel. Click the Save Motion button.
As shown below, the motion is revised on the Setup Canned Motion List page.
Delete Canned Motion
Navigate to IRB Assistant > Review Board Administration > [System Setup tab] > Setup Canned Motion link.
The Setup Canned Motion List page opens. Select the checkbox(es) in the far-left column for the motion(s) to be deleted, then click the Delete Selected Motion(s) button.
A confirmation popup window displays.
Click CANCEL to return to the Setup Canned Motion List page without deleting the motion(s).
Click CONFIRM to delete the motion(s) and return to the Setup Canned Motion List page. The motion(s) is(are) deleted.
Setup Template Language
The iRIS™ system provides the ability for institutions to configure a list of predefined (“canned”) text blocks for insertion in Minutes, Agendas, and Outcome Letter documents via an Insert Template Language button, as shown in the IACUC example below.
To access the configuration list, navigate to IRB Assistant > Review Board Administration > [System Setup tab] > Setup Template Language link.
The Setup Template Language List page opens.
Any block of template language configured here is saved as a Merge Code and made available for insertion in Minutes, Agendas, and Outcome Letters via an Add Canned Language button on the applicable processing pages.
See the Using Merge Codes in Document Templates section of this manual for more information about working with Merge Codes.
Add Template Language
Navigate to IRB Assistant > Review Board Administration > [System Setup tab] > Setup Template Language link.
The Setup Template Language List page opens. Click the Add a New Approved Text button.
As shown below, an Add a language item panel opens for configuration of the text block.
Enter a descriptive Name and the desired Merge Code to be assigned to the block of text. Note that the code must include underscores where spaces occur between words, and cannot include any special characters (e.g., &, #, etc.).
In the example below, a Name and Code are entered. Click the click here to add the language text link.
The Approved Template text page opens with a text editor for entry and formatting of the text block. Notice that no Insert Merge Code button is available on this page. This is because the text block entered here will itself be saved as a Merge Code, and Merge Codes cannot be nested within text blocks.
In the example shown above the desired text is entered. Click the Save Change button. The text block is added to the Add a language item panel.
Click the Save Approved Text button. As shown below, the item is added on the Setup Template Language List page.
Edit Template Language
Navigate to IRB Assistant > Review Board Administration > [System Setup tab] > Setup Template Language link.
The Setup Template Language List page opens. Click the icon in the Edit column for the applicable item.
As shown below, an Edit a language item panel opens for revision of the text block.
Make desired changes to the Name and Merge Code fields. Note that the code must include underscores where spaces occur between words, and cannot include any special characters (e.g., &, #, etc.).
Click the click here to add the language text link to edit the text block. As shown below, the text block is opened for editing in the Approved Template text page.
Notice that no Insert Merge Code button is available on this page. This is because the text block entered here will itself be saved as a Merge Code, and Merge Codes cannot be nested within text blocks.
Make desired changes to the text block, then click the Save Change button. As shown below, the text is added to the Edit a language item panel. Click the Save Approved Text button.
The edit panel closes, and the item is revised.
Delete Template Language
Navigate to IRB Assistant > Review Board Administration > [System Setup tab] > Setup Template Language link.
The Setup Template Language List page opens. Select the checkbox(es) in the far-left column for the item(s) to be deleted, then click the Delete Approved Text button.
A confirmation popup window displays.
Click CANCEL to return to the Setup Template Language List page without deleting the item(s).
Click CONFIRM to delete the item(s) and return to the Setup Template Language List page. The item(s) is(are) deleted.
Setup Review Cycle
The iRIS™ system provides the ability to configure standardized review cycle terms for use in submission processing date calculations.
Navigate to IRB Assistant > Review Board Administration > [System Setup tab] > Setup Review Cycle link.
The Setup Review Cycle List page opens, as shown below.
Review cycles configured here populate the Review Cycle dropdown picklist on the Outcome tab of submission processing screens (red box and arrow in screenshot below).
When an item is selected from the Review Cycle picklist on an approved submission, the IRB Expiration Date field automatically calculates the corresponding expiration date (blue box and arrow in screenshot above) based on the Submission Approval date.
Note that where the Review Cycle field is left blank the user designates an expiration date using the calendar widget provided for the expiration date field.
Add Review Cycle
Navigate to IRB Assistant > Review Board Administration > [System Setup tab] > Setup Review Cycle link.
The Setup Review Cycle List page opens, as shown below. Click the Add a Review Cycle button.
An add panel is opened for creation of the new review cycle. Enter a descriptive Name, then enter the number of months for the cycle in the Review Cycle Number in Months field. An example of the filled panel is shown below.
Click the Save Review Cycle button to save the new review cycle and close the add panel. As shown below, the new review cycle is added on the Setup Review Cycle List page.
Edit Review Cycle
Navigate to IRB Assistant > Review Board Administration > [System Setup tab] > Setup Review Cycle link.
The Setup Review Cycle List page opens, as shown below. Click the icon in the Edit column for the applicable review cycle.
The selected review cycle is opened in an edit panel. Make desired changes to the Name and Review Cycle Number in Months fields, then click the Save Review Cycle button to save changes and close the edit panel.
The review cycle is revised on the Setup Review Cycle List page.
Delete Review Cycle
Navigate to IRB Assistant > Review Board Administration > [System Setup tab] > Setup Review Cycle link.
The Setup Review Cycle List page opens, as shown below. Select the checkbox(es) in the far-left column for the review cycle(s) to be deleted, then click the Delete Review Cycle(s) button.
A confirmation popup window displays.
Click CANCEL to return to the Setup Review Cycle List page without deleting the selected review cycle(s).
Click CONFIRM to delete the item(s) and return to the Setup Review Cycle List page. The review cycle(s) is(are) deleted.
Setup Submission Codes
An add-on feature is available to enable System Administrators to organize study submissions to IRB by color code. The property system.use_IRB_identifying_codes, accessed under System Administration > System Configuration > Reserved Settings, toggles this feature on or off.
NOTE: This is a reserved setting; please inquire with your iMedRIS contact for assistance.
When the property is set to “Yes” the color code option is turned on and a rb.use_identifying_codes property becomes available in Review Board Administration under Board Configuration Options > Submissions.
When the rb.use_identifying_codes property is set to “No”, the user cannot configure study codes in the system.
When set to “Yes”, the property displays a new column for codes to be configured in the board submissions area, Analyst Dashboard, and the General Information tab on the board in the submissions processing page. In addition, a new Setup Submission Codes link is added to the Board Administration page for Review Board members with access to set up submission codes.
When the Setup Submission Codes link is clicked, the Setup Review Board Submission Codes page is displayed.
Also, when the system.use_IRB_identifying_codes and rb.use_identifying_codes properties are both set to “Yes”, a new, editable “CPT Code” label becomes available under System Administration > List Configuration and Maintenance > Setup System Labels.
Here the Administrator can edit the desired label for the column where the code(s) will appear in the Submission and Analyst Dashboard, as well as in the General Information tab for the applicable board in submissions processing.
The Predefined Name shown on the new label is CPT Code. The user can change it by entering a desired name in the Alternate Name field and clicking the Save Label button.
The new properties turn on color coding for labels in a new CPT Code column next to the Study Classification column in the Submissions dashboard. The column name is taken from the system label, either the Predefined Name of CPT Code or the custom name entered by the user in the Alternate Name field. In the example shown below, an Alternate Name of Codes has been entered.
The new column populates with configured codes (e.g., label, color, and logic).
When the user hovers over a color code label, a tooltip description displays (shown below).
Where configured, color codes also appear in submission processing queue pages (shown below).
Setup Submission Outcome Validation
It is possible to apply automated, custom validation checks prior to applying a submission outcome, in order to enforce institution policies and practices. For example, prior to applying an “Approved” outcome a validation check can be run against the Study Status field on the submission form to verify the study is in an “Active” status, and if it is not, return an error message to the user instead of an outcome.
Navigate to IRB Assistant > Review Board Administration > [System Setup tab] > Setup Submission Outcome Validation link to access the Setup Review Board Submission Outcome Validations page (shown below).
All configured outcome validations are listed here.
Note that because the validation rules work in much the same manner as a database query, some familiarity with Structured Query Language (SQL) is required to build effective validation rules.
Add Submission Outcome Validation
Navigate to IRB Assistant > Review Board Administration > [System Setup tab] > Setup Submission Outcome Validation link.
All configured outcome validations are listed here. Notice the Order column (see screenshot below).
The Order column value dictates the order in which the validation rules are applied to the submission. The rules are applied in ascending order beginning with Order value “10”. The rules can be re-ordered at any time by editing the values in the Order column and clicking the Save Validation Order button (see screenshot above), or by editing the individual records to apply a new Order value. See the Edit Submission Outcome Validation section of this manual for more information about editing validation rule records.
If a new rule with a duplicate Order value is created, or if the Order value of an existing rule is revised such that a duplicate Order value is created, the newly created or revised rule retains the entered Order value and all Order values for preexisting, higher order rules are automatically incremented upward. For example, given the screenshot below, if a new rule is created with Order value “10” the “Expiration Date – QSF Jacob” rule Order value changes to “20”, the “IRB of Record and Outcome” rule Order value changes to “30”, and the “Review Cycle” rule Order value changes to “40”.
Note that because the validation rules work in much the same manner as a database query, some familiarity with Structured Query Language (SQL) is required to build effective validation rules.
Click the Add Validation button (shown in screenshot above). The Add Outcome Validation popup opens, as shown below.
Notice that the Order field (upper right in screenshot above) defaults to the next available Order number, in ascending order, which in this case is “40”. Because this rule is intended to be evaluated first however, its Order number is changed to “10”. When the record is saved this rule retains the Order value of “10” and the Order value of all three preexisting rules is incremented upward.
In the screenshot below, the Order value is changed to “10”. Complete the remaining fields as follows.
Validation Name — enter the name of the rule
This validation is associated which submission form — click in the field to open a list of forms currently configured in the system (see screenshot above); scroll to the form containing the data value to be validated and click to select that form
Validation Field Association — click this button (see screenshot below) to select the specific field to be validated in the selected form
As shown below, the Review Board Outcome Field Selection popup opens. Scroll to the applicable field and click to select it, then click the Save button at the bottom right of the popup to save the selection and close the popup.
Edit Error Message — click this button (see screenshot below) to create a custom error message for display to the user when the submission fails this validation check
As shown below, the Enter the Error Message for this Validation popup opens. Enter the error message text and format it as desired, then click the Apply button at the lower right to save the message.
Tool Tip — enter any desired Tool Tip (mouseover) text, as shown below
What to Validate — click in the field to open a drop down pick list, as shown below; click in the list to select “Applic. Form all columns”, “Current Form all columns”, “Submission attributes” or “Submission Outcome selection”
Validation Field Association — click this button to select the specific field to be validated from the item specified in the What to Validate field
As shown below, the Review Board Outcome Field Selection popup opens. Scroll to the applicable field and click to select it, then click the Save button at the bottom right of the popup to save the selection and close the popup.
As shown below, the selected field populates in the Data Value column.
Join by, if any — select the desired join type (see screenshot below) to add a further validation rule to this record; note that because the validation rules work in much the same manner as a database query, some familiarity with Structured Query Language (SQL) is required to build effective validation rules and this is especially true with compound rules
In this example there is no join because only one field validation is required.
comparator — in the What to Validate column (see screenshot below), click in the comparator field to open a pick list of options, and click the desired comparator to select it
comparison type — in the What to Validate column (see screenshot below), beneath the comparator field, click in the comparison type field to open it and click to select either “Value” or “Submission Outcome selection”
Note that because “Submission Outcome selection” is already selected in the first What to Validate field, it wouldn’t make sense to make the same selection for comparison type because that would result in the “Submission Outcome selection” being compared to itself.
comparison value — when “Value” is selected for comparison type, this field populates with a drop down list of possible values configured in the system for the selected field (see screenshot below); when “Submission Outcome selection” is selected for comparison type, this field populates with a list of Submission Outcome types configured in the system; click the desired value to select it
When all fields are complete click the Save button (see screenshot below) to close the popup and create the record.
The new rule is added on the Setup Review Board Submission Outcome Validations page, as shown below. Notice that because the new rule was created with an Order value of “10”, the three preexisting rules’ Order values are incremented upward.
Edit Submission Outcome Validation
Navigate to IRB Assistant > Review Board Administration > [System Setup tab] > Setup Submission Outcome Validation link.
All configured outcome validations are listed here. Notice the Order column (see screenshot below).
The Order column value dictates the order in which the validation rules are applied to the submission. The rules are applied in ascending order beginning with Order value “10”. The rules can be re-ordered at any time by editing the values in the Order column and clicking the Save Validation Order button (see screenshot above), or by editing the individual records to apply a new Order value.
Click the applicable icon in the Edit column to open the corresponding rule for editing.
The Edit Outcome Validation popup opens, as shown below.
Make desired changes to the fields on the popup, which are as follows.
Order — priority order in which this rule will be applied to the submission; rules are applied in ascending order beginning with Order value “10”
If the Order value of an existing rule is revised such that a duplicate Order value is created, the revised rule retains the entered Order value and all Order values for preexisting, higher order rules are automatically incremented upward.
For example, given the screenshot above, if the “Review Cycle” rule Order value is changed from “30” to “10” the “Expiration Date – QSF Jacob” rule Order value changes to “20”, the “IRB of Record and Outcome” rule Order value changes to “30”, and the “Review Cycle” rule is moved to the top of the list with an Order value of “10”.
Validation Name —name of the rule
This validation is associated which submission form — click in the field to open a list of forms currently configured in the system (see screenshot above); scroll to the form containing the data value to be validated and click to select that form
Validation Field Association — click this button to select the specific field to be validated in the selected form
As shown below, the Review Board Outcome Field Selection popup opens. Scroll to the applicable field and click to select it, then click the Save button at the bottom right of the popup to save the selection and close the popup.
Edit Error Message — click this button to create a custom error message for display to the user when the submission fails this validation check
As shown below, the Enter the Error Message for this Validation popup opens. Revise the error message text and format it as desired, then click the Apply button at the lower right to save the message.
Tool Tip — Tool Tip (mouseover) text
What to Validate — click in the field to open a drop down pick list, as shown below; click in the list to select “Applic. Form all columns”, “Current Form all columns”, “Submission attributes” or “Submission Outcome selection”
Validation Field Association — click this button (shown below) to select the specific field to be validated from the item specified in the What to Validate field
As shown below, the Review Board Outcome Field Selection popup opens. Scroll to the applicable field and click to select it, then click the Save button at the bottom right of the popup to save the selection and close the popup.
Join by, if any — select the desired join type (see screenshot below) to add a further validation rule to this record; note that because the validation rules work in much the same manner as a database query, some familiarity with Structured Query Language (SQL) is required to build effective validation rules and this is especially true with compound rules
In this example there is no join because only one field validation is required.
comparator — in the What to Validate column (see screenshot below), click in the comparator field to open a pick list of options, and click the desired comparator to select it
comparison type — in the What to Validate column (see screenshot below), beneath the comparator field, click in the comparison type field to open it and click to select either “Value” or “Submission Outcome selection”
Note that because “Submission Outcome selection” is already selected in the first What to Validate field, it wouldn’t make sense to make the same selection for comparison type because that would result in the “Submission Outcome selection” being compared to itself.
comparison value — when “Value” is selected for comparison type, this field populates with a drop down list of possible values configured in the system for the selected field (see screenshot below); when “Submission Outcome selection” is selected for comparison type, this field populates with a list of Submission Outcome types configured in the system; click the desired value to select it
When all fields are complete click the Save button (see screenshot below) to close the popup and save changes.
The rule is revised and its location in the list is changed as necessary to correct any Order value changes.
Delete Submission Outcome Validation
Navigate to IRB Assistant > Review Board Administration > [System Setup tab] > Setup Submission Outcome Validation link.
The Setup Review Board Submission Outcome Validations page opens, as shown below. All configured outcome validations are listed here.
Click the applicable icon(s) in the Remove column to delete the corresponding rule(s). A confirmation popup window displays.
Click CANCEL to return to the Setup Review Board Submission Outcome Validations page without deleting the selected rule(s).
Click CONFIRM to delete the item(s) and return to the Setup Review Board Submission Outcome Validations page. The rule(s) is(are) deleted, and Order values on the page are automatically updated.
For example, given the screenshot above, if the “Expiration Date – QSF Jacob” rule is deleted, the “IRB of Record and Outcome” rule is moved to the top of the list with its Order value changed to “10”, and the “Review Cycle” rule is moved to the second position in the list with an Order value of “20”.
Setup COI Status KSP / KPP Display
The COI Status panel is where details of Key Study Personnel (KSP) Conflicts of Interest (COI) are displayed. This panel appears in the General Information tab of the Submissions area, and on the COI Status page. The contents of the panel are configured on the Setup COI Status KSP Display page (shown below).
To access the page, navigate to IRB Assistant > Review Board Administration > [System Setup tab] > Setup COI Status KSP/KPP Display link.
All items shown appear in the COI Status panel by default, in the locations shown.
To remove an item from the panel, click the corresponding Delete icon (red circle with a white X in the center).
Note that the plus sign/minus sign (expand/compress) icon in the View Conflict Matches column, and therefore the expanded view presented to users in the sub-table (shown in screenshot above), only populate in the panel when the View Conflict Matches box is present. If this item is deleted from the display, users cannot expand the view for conflict match details.
When the Show Plan button item is deleted the user can see that a plan is in place but cannot view the specific plan.
If an item is removed in error, click the Reset Columns button to reset the panel to its default view.
When desired changes are complete click the Save Columns button. Changes can be confirmed in the COI Status panel in the General Information tab of the Submissions area, or on the COI Status page
Review Board Notification Setup
The Review Board Notification Setup panel, accessed via IRB Assistant > Review Board Administration > [System Setup tab], provides links for configuration of various standardized notification types to be sent to applicable study personnel and board members.
Notifications configured here are automatically sent to applicable personnel when study tasks (e.g., review, signoff, set meeting availability, etc.) are assigned, completed, or overdue.
See the RBA Notifications manual for details of RBA notification configuration and management.
List Maintenance Setup Tab
The iRIS™ system provides numerous picklists on system pages and forms. Some of these lists exist to save users the time and inconvenience of manually typing in frequently used data items. Other lists exist to enforce data validation requirements.
In the IRB Assistant module, system lists are accessed via IRB Assistant > Review Board Administration > List Maintenance Setup tab.
See the IRB Assistant – List Maintenance manual for details of list configuration processes and settings.
Clean-up Tab
The Clean-up tab under IRB Assistant > Review Board Administration provides access to pages that allow the system administrator to transfer tasks among staff members and unlock orders for editing.
Transfer outstanding tasks
When a Coordinator leaves the institution, tasks assigned to that user must be reassigned to a different user in order to avoid any breaks in study processing continuity.
IMPORTANT: the iRIS™ user profile for the Coordinator whose tasks are being reassigned must still exist in the system, and that user must be designated as a Coordinator.
This process is completed on the Transfer RB Tasks page. To access the page, navigate to IRB Assistant > Review Board Administration > Clean-up tab > Transfer outstanding tasks link.
The Transfer RB Tasks page opens, as shown below.
Here, the System Administrator or designee can look up a Coordinator name, view tasks assigned to that Coordinator, and reassign them individually or in a group to one or more other, active Coordinators in the system.
Click in the Select the user that tasks are currently assigned to field to open a dropdown list of users assigned to the role of Coordinator.
Click an item in the list to select the name of the Coordinator whose tasks are to be reassigned.
As shown below, all tasks currently assigned to the selected Coordinator populate in the Study Title/ Task type list.
Select the checkbox(es) for the task(s) to be reassigned to a different Coordinator.
Note that in the example above all tasks are selected, but individual tasks can also be reassigned to different Coordinators by selecting a single task and repeating the process of reassignment multiple times.
Click in the Select the user who will accepts these tasks field to open a dropdown list of users currently assigned to the role of Coordinator.
Click an item in the list to select the name of the Coordinator to whom the selected task(s) is(are) to be reassigned, then click the Transfer task to new user button.
A confirmation popup briefly displays, then closes automatically when its countdown timer expires.
The reassigned tasks now appear in the Workspace(s) of the new assignee(s).
Document Management
Study document version merge functionality is provided via IRB Assistant > Review Board Administration > Clean-up tab > Document Management link.
The link opens the Find A Study page, as shown below.
Enter / select desired search criteria in the Find a Study Filters section (described below), and click the Find button to execute the search. Click the Reset Find Options button to reset all filter fields.
The Display Projects by dropdown allows for selection by number type (e.g., study/protocol number, IRB number).
Text entry fields are provided to search by full or partial Study Number/Alias, Sponsor name, Department, IRB Number or Reference number.
The Principal Investigator (PI) field can be used to search by full or partial PI name and includes a button to toggle the search between Active or Inactive PIs. As shown below, the button is toggled to Active by default.
Click the Active button to toggle it to Inactive, as shown below.
Note that it is not possible to search by both Active and Inactive PIs simultaneously.
The Location Status dropdown allows for selection by Location Status. Note that Location Status is configured by the institution under System Administration > Setup Locations Status.
The Study Status dropdown provides a pick list to filter the search by study status. Click an item in the list to select it.
The Study Classification dropdown provides a pick list to filter the search by study classification. Click an item in the list to select it.
Calendar widgets are provided for searching by IRB Expiration Date range. Available date range options are as follows:
— to limit the search to studies whose IRB Expiration Date occurs on or after a specific date, click the left-hand calendar widget and select the desired start date; leave the right-hand date field blank
— to limit the search to studies whose IRB Expiration Date occurs on or before a specific date, click the right-hand calendar widget and select the desired end date; leave the left-hand date field blank
— to limit the search to studies whose IRB Expiration Date occurs between two specific dates, select the desired start date using the left-hand calendar widget and the end date using the right-hand calendar widget
Find a Study Results Section
As shown in the screenshot below, after search criteria and filters are applied and the Find button is clicked, results are displayed in the lower part of the Find a Study page.
Columns in the results section of the page are:
Select – click the icon in this column to open the Document Management page and proceed with merging document versions (see the Merging Document Versions subsection of this manual)
Study Status – current study status (e.g. Open, Pending, Draft, Completed)
Location – current study location
Location Status – status of the study at the specified location
IRB Number – IRB number assigned to the study, if any
2019 Common Rule? – whether or not the study is subject to the 2019 Common Rule; see the Common Rule Display section of this manual for more information
IRB Expiration Date – IRB expiration date, if any
Note that the title and contents of the IRB Number and IRB Expiration Date columns are dictated by the Display Projects by filter setting in the upper part of the Find a Study page, shown below.
Study Alias [or Number] – Nickname/Number given to the study in the Study Application
Study Title – Study Title entered in the Study Application
Principal Investigator – name of the Principal Investigator on the study
Sponsor –name of the Sponsor on the study
Merging Document Versions
When the desired study is listed in the results section of the Find a Study page, click the applicable icon in the Select column.
The selected study is opened in the Document Management page.
All version 1.0 study documents associated with the selected study are listed in a Root Documents table. Click the icon in the Select Root Document column for the applicable document.
All versions of the selected document populate, and the Select Root Document column is replaced with a Select Document column containing select checkboxes. Prepare Changes, Select a Different Root Document and Filter Documents buttons populate in the upper right corner above the table.
Click the Select a Different Root Document button to revert to the prior version of the Root Document table, where a different root document can be selected.
Select the checkbox(es) for all document versions to be merged with the root (version 1.0) document and click the Prepare Changes button.
The selected documents are opened in a Prepare Changes popup window. If multiple versions of the same root document are chosen from the Root Documents table, all versions of that document are selected by default in the popup.
Columns in the popup are:
— Document Title: original name of the document, editable
— Current Version: current version of the document
— Proposed Version: suggested version of the document following the merge, editable
— Category: category to which the root document is assigned, editable
Any versions of the root document that were not chosen from the Root Document table also appear in the popup but are not selected by default. Click the applicable blank box(es) in the far-left column to select the additional document version(s) to be merged, as shown in the screenshot below.
Note that the documents to be merged can have different Document Titles.
Click the Merge Documents button. The Prepare Changes popup is updated with proposed merged document version details.
Note that in the example shown above only the top three document versions were selected.
Click the icon in the View History column to preview document version history as it will appear after the merge is complete.
Click any document icon in the File column to open that version of the document in a separate, read-only window.
Click the Cancel button to cancel the merge and return to the pre-merge version of the Prepare Changes popup, as shown below.
Click the Confirm button to complete the merge. A confirmation popup appears.
Click CANCEL to close the confirmation popup and return to the Prepare Changes popup.
Click CONFIRM to complete the merge. The selected versions are merged and a “Documents have been reorganized” countdown popup briefly appears. The countdown popup closes and an updated version of the Root Documents table is loaded.