The iRIS™ Conflict of Interest Assistant module groups tasks relevant to management and tracking of conflicts of interest among Covered Persons. This manual is focused on Conflict of Interest 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. 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.

NOTE: screenshots in this section are primarily taken from the Animal Resource Center (ARC) module, but navigtion functionality and features described in this section are the same in all modules.

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.

System Setup Tab

System Setup is the first tab on the Board Administration page. This section allows review board administrators to manage general module setup, define review board details, set up review board roles and access, create document templates, change labels for data fields within the module, and perform similar module configuration tasks.

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.

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 COI it is only possible to copy configurations across COI review boards.

Click the Copy Configurations button to copy a pre-existing COI review board configuration to another COI 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 unlocked. Note that certain configuration items of the COI review board cannot be copied. These include:

— Setup Review Board Roles

— Setup Electronic Document Stamp

— Setup Management Plan

— Setup Correspondence Template

— Setup COI Annual Due

— Annual COI Form Label Configuration List

— Annual COI Notification

— Conflict of Commitment Reviewer Notification Setup

— New Study/Project Conflict of Interest Notifications Setup

— Management Plan Notification

— Study Status Configuration List

— Configure COI Lists

Select the configuration item(s) to be copied to the selected destination by clicking the respective checkbox(es). 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.  

Board Definition

Review boards are defined, edited and deleted in the Board Administration area. To define a board, Navigate to Conflict of Interest Assistant > Review Board Administration and click the Board Definition link on the System Setup tab.

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 Conflict of Interest Assistant > Review Board Administration and click the Board Configuration Options link on the System Setup tab.

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 will 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 Conflict of Interest — Properties manual for more information on each individual property.

Setup Committee List

The Setup Committee List page is where current review board committees can be viewed, edited or deleted, and new committees added.

Note that there are costs to the institution for each review board and committee defined in their iRIS™ system.

Edit Committee

Navigate to Conflict of Interest Assistant > Review Board Administration > System Setup tab and click the 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 Conflict of Interest Assistant > Review Board Administration > System Setup tab and click the 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 have a slightly modified main menu, enabling them to select the applicable committee for various tasks.

Delete Committee

Navigate to Conflict of Interest Assistant > Review Board Administration > System Setup tab and click the Setup Committee List link.

The Setup Committee List page is opened. Select the checkbox in the far-left column 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.

The page is accessed via Conflict of Interest Assistant > Review Board Administration > System Setup > Setup Review Board Roles link.

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 Conflict of Interest 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 Conflict of Interest Assistant > Review Board Administration > System Setup tab and click the 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 For list under Conflict of Interest 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

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 Conflict of Interest Assistant > Review Board Administration > System Setup tab and click the 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 Conflict of Interest 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 Conflict of Interest Assistant > Review Board Administration > System Setup tab and click the 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.

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.

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 you want the corresponding data value to appear, then click the Insert Merge Code button to open the Merge Codes picklist.

NOTE: screenshots and examples in this section are primarily taken from the Animal Resource Center (ARC) module, but functionality and features described in this section are the same for Conflict of Interest Assistant as for ARC.

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.

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:

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 Meetings

Categories and Merge Codes from the list that are most applicable to meetings are summarized in the table below.

Setup Agenda Categories

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.

Once configured, these 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 Conflict of Interest 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

Add Agenda Category

Click the Setup Agenda Categories link under Conflict of Interest Assistant > Review Board Administration > System Setup tab.

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.

Click the Save All Changes button to save the record. The category is added on the Set-up Agenda Categories page.

Edit Agenda Category

Click the Setup Agenda Categories link under Conflict of Interest Assistant > Review Board Administration > System Setup tab.

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.

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

Click the Setup Agenda Categories link under Conflict of Interest Assistant > Review Board Administration > System Setup tab.

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 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, click the Setup Finalized Agenda Document Template link under Conflict of Interest Assistant > Review Board Administration > System Setup tab.

The Finalized Agenda Templates page opens, as shown below. Notice the two instruction items and the corresponding button type 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 will serve as the basis for all finalized agenda documents, and therefore it should include all items considered standard and necessary to any finalized agenda.

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.

See the Setup Agenda Categories section of this manual for more information about configuration of custom agenda categories.

Again, recall that the template will serve 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.

When section definition content is complete, click the Save Change button to close the page and save the section definition.

Going forward, each 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 Conflict of Interest Assistant – Meetings manual for more information about meeting 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 Setup Board Agenda Revision Templates page. To access the page, click the Setup Agenda Revision Document Template link under Conflict of Interest Assistant > Review Board Administration > System Setup tab.

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 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, click the Setup Meeting Minutes Template link under Conflict of Interest Assistant > Review Board Administration > System Setup tab.

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 Management Plan

The iRIS™ system provides the ability to configure standardized COI management plan templates that include commonly used boilerplate text and can automatically pull a variety of system data into the documents when they are generated.

This functionality is provided on the Setup Management Plan page. To access the page, click the Setup Management Plan link under Conflict of Interest Assistant > Review Board Administration > System Setup tab.

The Setup Management Plan page opens, as shown below.

Add Management Plan

Navigate to Conflict of Interest Assistant > Review Board Administration > System Setup tab > Setup Management Plan link.

The Setup Management Plan 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.

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 Management Plan

Navigate to Conflict of Interest Assistant > Review Board Administration > System Setup tab > Setup Management Plan link.

The Setup Management Plan 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.  

Make desired changes to the Title and Comments fields.

Make desired changes to 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 revised on the Setup Board Letter Templates page.

Delete Management Plan

Navigate to Conflict of Interest Assistant > Review Board Administration > System Setup tab > Setup Management Plan link.

The Setup Management Plan page opens, as shown below.

Select the checkbox in the far-left column for the item to be deleted and click the Delete Selected Template(s) button. A confirmation popup displays.

Click the CANCEL button to return to the Setup Management Plan Templates page without deleting the selected template(s).

Click the CONFIRM button to confirm the deletion and return to the Setup Management Plan Templates page.

The item is deleted on the Setup Management Plan Templates 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, click the Setup Outcome Letter Templates link under Conflict of Interest Assistant > Review Board Administration > System Setup tab.

The Setup Board Letter Templates page opens, as shown below.

Add Outcome Letter Template

Navigate to Conflict of Interest 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

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 Conflict of Interest 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 demonstrated in the example 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

The two tabs in the lower part of the edit panel offer two different methods for revising the template’s content.

The HTML Content tab 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. Click 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 Conflict of Interest 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 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.

To access the list, click the Setup Canned Motion link under Conflict of Interest Assistant > Review Board Administration > System Setup tab.

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 Conflict of Interest 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, then click the Save button.

The text editor closes and the text is added to the add 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 Conflict of Interest 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. The text is added to the edit panel. Click the Save Motion button.

The motion is revised on the Setup Canned Motion List page.

Delete Canned Motion

Navigate to Conflict of Interest 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 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, click the Setup Correspondence Template link under Conflict of Interest Assistant > Review Board Administration > System Setup tab.

The Setup Board Correspondence Templates page opens, as shown below.

Correspondence Templates are used when creating a correspondence record for a Conflict Match in the Conflict Match processing screens. A drop down pick list of available templates is provided above the embedded text editor.

The desired template is selected from the drop down pick list and when the Import template button is clicked, the template’s content is pulled into the text editor.

Add Correspondence Template

Navigate to Conflict of Interest 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 Conflict of Interest 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 Conflict of Interest 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 COI Annual Due

The iRIS™ system provides a Setup Annual COI Due Dates page for entry and tracking of each institution’s due date for receiving the Annual COI Form from Covered Persons in the system. To access the page, navigate to Conflict of Interest Assistant > Review Board Administration > System Setup tab > Setup COI Annual Due link.

The Setup Annual COI Due Dates page opens, as shown below.

The page lists any annual COI due dates configured previously. Note that due dates in the past cannot be edited or deleted, and are retained for archive purposes. Future due dates can be modified or deleted.

Note that COI Due Date Notifications trigger based on the individual user’s assigned COI Due Date and NOT the Annual COI Due Date taken from the Setup Annual COI Due Dates page. The Setup Annual COI Due Dates page is provided to allow for simultaneous assignment of one due date to multiple Covered Persons.

Annual COI Due Field in the User Profile

Where the user is a Covered Person, Annual COI Due and Reset COI Due to a year from above if annual form submitted fields (red box in screenshot below) appear in the user profile under System Administration > User Accounts:

As shown in the screenshot above, the Reset COI Due to a year from above if annual form submitted field defaults to “No”. When this field is set to “Yes” the system performs the following check and possible update during overnight processing:

• If an annual COI form was submitted for the applicable user on the previous day, the system updates the Annual COI Due field for the applicable user to 365 days in the future
• If an annual COI form was not submitted for the applicable user on the previous day, the system makes no changes to the Annual COI Due field  

If configured, the applicable user receives a task to complete a new annual COI form on the specified Annual COI Due date.  

Preexisting users in the system automatically update to a future Annual COI Due Date when their existing Annual COI Due Date has passed. For example, if a user has a COI due date of 1/1/2020 and the next Annual COI Due Date in the system is scheduled for 1/1/2021, after 1/1/2020 has passed, the system updates the user account with the COI due date of 1/1/2021, in anticipation of the next year’s Annual COI Due Date.

New hires to the institution receive a separate Annual COI Due Date, set to five days after the new hire’s iRIS™ account is created. When that date passes the system updates the new hire’s account with the next upcoming Annual COI Due Date, as defined in the Setup Annual COI Due Date page.

Annual COI Due Column in Search Conflict Matches Page

The Annual COI Due field column on the Search Conflict Matches page (shown in screenshot below) is populated from the Annual COI Due field. This field is editable and any changes made to it post to the same column in the database whether revised in this location or the User Profile.  

Add COI Annual Due

Navigate to Conflict of Interest Assistant > Review Board Administration > System Setup tab > Setup COI Annual Due link.

The Setup Annual COI Due Dates page opens, as shown below.

Click the Add a New due date button. A panel opens for selection of the date from a calendar widget, as shown below.

Click the calendar widget to open it. Navigate to the desired date and click to select it.

Click the Save due date button to close the add panel and save changes.

The date is added on the Setup Annual COI Due Dates page.

Edit Annual COI Due

Navigate to Conflict of Interest Assistant > Review Board Administration > System Setup tab > Setup COI Annual Due link.

The Setup Annual COI Due Dates page opens, as shown below.

Click the icon in the Edit column for the applicable date. The selected date is opened in an edit panel, as demonstrated in the example below.

Click the calendar widget to open it. Navigate to the desired date and click to select it.

Click the Save due date button to close the edit panel and save changes.

The item is revised on the Setup Annual COI Due Dates page.

Delete Annual COI Due

Navigate to Conflict of Interest Assistant > Review Board Administration > System Setup tab > Setup COI Annual Due link.

The Setup Annual COI Due Dates page opens, as shown below.

Select the checkbox in the far-left column for the item to be deleted and click the Delete Selected due date(s) button. A confirmation popup displays.

Click the CANCEL button to return to the Setup Annual COI Due Dates page without deleting the selected template(s).

Click the CONFIRM button to confirm the deletion and return to the Setup Annual COI Due Dates page.

The item is deleted on the Setup Annual COI Due Dates page.

Annual COI Form Label Configuration List

In iRIS™ systems where the Annual COI Form uses predefined data values, the Setup COI Labels page is used to configure label data values. To access the page, navigate to Conflict of Interest Assistant > Review Board Administration > System Setup tab > Annual COI Form Label Configuration list link.

The Setup COI Labels page opens, as shown below. Each collection of COI labels is preceded by an identifying title in bold face text (red box in screenshot below).

Any of the predefined values listed in the Setup COI Labels page can be used in the Forms Designer when constructing an Annual COI Form.

To revise a label, click the icon in the Edit column for the applicable item. The label is opened in an edit panel, as shown below.

The original label is displayed in the Predefined Name field, which is read-only.

Make desired changes to the Alternate Name and Description fields.

Click the Save Label button to save changes and close the edit panel.

The item is updated on the Setup COI Labels page, as shown above.

As shown below, any label change made in the Setup COI Labels page updates the corresponding data value in any Annual COI Form where the label is used.

Setup Business Associate Type

The iRIS™ system provides tools for creation and maintenance of a Business Associate List, with business associates (sponsors) classified by Business Associate Type. A pick list of types is configured via the Setup Sponsor Type page. To access the page, navigate to Conflict of Interest Assistant > Review Board Administration > System Setup tab > Setup Business Associate Type link.

The Setup Sponsor Type page opens, as shown below.

Add Business Associate Type

Navigate to Conflict of Interest Assistant > Review Board Administration > System Setup tab > Setup Business Associate Type link.

The Setup Sponsor Type page opens, as shown below.

Click the Add a New Category button. An add/edit panel opens for creation of the type, as shown below.

Complete the form as follows:

Sponsor Type – enter the desired display name for the Sponsor Type record

Sort Order Number – enter the desired order number for sorting, duplicates are allowed; if more than one type is assigned to the same Sort Order Number, a secondary sort in alphabetical order is applied

Include Sponsors of this group in Disclosure Search – select “Yes” to include sponsors of this type in the conflict of interest match processing check; if this flag is set to “Yes”, when a Covered Person submits an Annual COI Form containing a conflict match with a sponsor of this type, the system flags a COI match and reports it to the Conflict of Interest board

Description – enter any desired description for the type

Click Save Category to close the add panel and save the Sponsor Type.

Edit Business Associate Type

Navigate to Conflict of Interest Assistant > Review Board Administration > System Setup tab > Setup Business Associate Type link.

The Setup Sponsor Type page opens, as shown below.

Click the icon in the Edit column for the applicable type. The selected type is opened for revision in an add/edit panel, as shown below (blank example).

Make desired revisions to the fields as follows:

Sponsor Type – enter the desired display name for the Sponsor Type record

Sort Order Number – enter the desired order number for sorting, duplicates are allowed; if more than one type is assigned to the same Sort Order Number, a secondary sort in alphabetical order is applied

Include Sponsors of this group in Disclosure Search – select “Yes” to include sponsors of this type in the conflict of interest match processing check; if this flag is set to “Yes”, when a Covered Person submits an Annual COI Form containing a conflict match with a sponsor of this type, the system flags a COI match and reports it to the Conflict of Interest board

Description – enter any desired description for the type

Click Save Category to close the add/edit panel and save changes.

Delete Business Associate Type

Navigate to Conflict of Interest Assistant > Review Board Administration > System Setup tab > Setup Business Associate Type link.

The Setup Sponsor Type page opens, as shown below.

Click the icon in the Delete column for the applicable type. A confirmation popup displays.

Click the CANCEL button to return to the Setup Sponsor Type page without deleting the selected template(s).

Click the CONFIRM button to confirm the deletion and return to the Setup Sponsor Type page.

The item is deleted on the Setup Sponsor Type page.

Setup Business Associate List

The iRIS™ system provides tools for creation and maintenance of a Business Associate List, with business associates classified by Business Associate Type. For more information, see the Conflict of Interest — Business Associate List manual.

Setup Notifications

The iRIS™ system provides tools for creation of editable, boilerplate Review Board Administration and system notifications. For more information about any of the functions shown in the Review Board Notification Setup menu (screenshot below), see the Conflict of Interest — Review Board Administration Notifications manual.

List Maintenance Setup Tab

The List Maintenance Setup tab under Conflict of Interest > Review Board Administration (screenshot below) contains a list of configurable dropdown lists for use in iRIS™.

For more information about any of the functions shown in the List Maintenance Setup tab, see the Conflict of Interest — List Maintenance manual.