Submission processing features are accessed via an icon on a study board’s Workspace. Depending on the system configuration, this icon may be a Submissions link or a Committee Submissions link.

Note: The information presented in this manual applies to all study boards in iRIS™, including IRB Assistant, IACUC Assistant, ARC Assistant, SRB Assistant, and IBC Assistant. In this case, screenshots and descriptions from IRB Assistant are used as an example.

Review Board Limited Administrative Rights

A new rb.use_limited_admin_rights property has been created under IRB Assistant > Review Board Administration > Board Configuration Options > 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 to the IRB module.

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 the board-level role access is set.

Note that the following screenshots show pages under the IRB board, but the same access is granted for this rights level under other review boards in the system.

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.

Common Rule Display

This feature allows review board members and reviewers to easily identity 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 of a submission.

A new property, rb.use_common_rule_display, has been added under IRB Assistant > Review Board Administration > Board Configuration Options > Study Board Properties. The property defaults to “No” and must be set 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 Study 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.

Documents Sync Across Boards for Parallel Submissions by Default

Beginning with version 12.01 of iRIS™, a new rb.use_latest_component_parallel_submission property is available under IRB Assistant > Review Board Administration > Board Configuration Options > Submission Review Properties. The default value of this property is “ Yes”.

When the property is set to “Yes” and a submission is sent to multiple boards, any new components attached to the submission by Board A automatically appear under submission components for Board B as well. This allows boards to always have access to the latest components of the submission. Setting this value to “No” maintains the previous functionality, where Board B only has access to the original components it received in the submission.

Note: When this setting is active, if Board A returns the submission back to the study side for corrections at the same time as Board B, study members always see the latest components in the submission and stipulations, no matter what was returned for corrections or by which board.

Board Submissions Page

The Board Submission Queues have been redesigned and expanded in this version of iRIS™ to provide more detail and granularity when browsing through submissions, as well as decrease the number of submission records populating per tab. This redesign will allow board members to determine, at-a-glance, the review stage of a certain submission simply by noting which queue tab in which the submission is located.

The new version of Submission Queues is described in this manual and is controlled by the property shown below in System Configuration > System Default Settings.

To return to the previous version of the Submission Queues, set this property to no.

The names of the new submission queue tabs and hover over text are configurable via the Setup UI Content page in System Administration > List Configuration and Maintenance > Setup UI Content. Labels are configurable by review board as shown below.

Click the Submissions or Committee Submissions link to open the Board Submissions page.

The page serves as a portal for all stages of submission processing. A filter box is provided at the top of the page. A table beneath the filters groups submission processing tasks into ten categories (tabs).

Each tab is discussed in detail below.

Not Assigned

The Not Assigned tab is selected by default. This tab lists submissions that have not yet been processed by the review board and have not been assigned an Analyst. If your institution is auto assigning an analyst through the workflow, all new submissions will appear in the Pre-Review tab initially.

Pre-Review

The Pre-Review tab lists submissions that have been assigned an Analyst and/or assigned a review process. This tab includes the same columns as those shown in the screenshot above for the Not Assigned tab with an added column for Review Process.

Review in Progress

The Review in Progress tab lists submissions that have been assigned one or more reviewers who have not yet completed their reviewer’s checklist. This tab includes the same columns as those shown in the screenshot above for the Pre-Review tab with the addition of two columns, one for Reviewers Assigned (scroll to the right) and one for Letters if applicable.

Review Complete

The Review Complete tab lists submissions where all assigned reviewers have completed their reviewer checklist. This tab includes the same columns as those shown in the Review in Progress screenshot above. Submissions in this queue are ready for the analyst or other staff to continue processing the submission.

Please note that Review Complete is the system default label for this queue.

Returned from Researchers

The Returned from Researchers tab lists Submission Correction and Response forms that have been returned by the researchers to the review board. This tab includes the same columns as those shown in the screenshot above. If an analyst is assigned to this round, the submission will move to the Pre-Review tab and then process through the other tabs as described above.

Pending Response

The Pending Response tab lists submissions that have been returned to the research team with changes or stipulations that need to be addressed. Once the successive rounds have been processed and no further corrections are requested, the submissions will move to the Completed Submissions tab. This tab includes the same columns as those shown in the screenshot above.

Completed Submissions

The Completed Submissions tab provides links to previously processed and completed submission forms that have not been sent back to the research team with change requests or stipulations.

In addition to the columns shown on the other tabs, the Completed Submissions tab includes columns for Letters and Date Completed. Hover over icons in the Letters column to view letter details. Letters that have been sent are labeled as such in the detail text (see screenshot below).

Agendas

The Agendas tab enables the review and management of agendas for scheduled review board meetings by board members. By default the tab displays the details of the next upcoming review board meeting.

Click the arrows to the left and right of the selected meeting date to browse other meeting dates. Arrows only populate when additional meetings exist. All submissions assigned to the selected meeting populate in the agenda categories, by type of submission, as shown in the example above. Click the icon in the Click to open column to open the corresponding submission.

Pending Action

The Pending Action tab lists submissions that are awaiting a response or contain pending study-side tasks.

Outstanding Board Tasks

The Outstanding Board Tasks tab contains a list of submissions that require action from the review board. The Task Type and Task Assigned columns indicate the tasks to be completed and to whom each task was assigned.

Submission Processing

Upon entering a submission, the menu links, as shown below, will appear on the left-hand side, allowing the user to navigate to different tabs or pages within submission processing. If a Review Process has not been set, only the first three tabs plus Submission Correspondence will display. Once a Review Process has been set, Submission Review and Submission Outcome will display.

Submission processing navigation menu.

Each new tab represents a submission processing page, and within each page are several sections representing individual processing steps. These sections correspond to the previous submission processing navigation tabs such as “General Information”, “Submission Component(s)”, “Outcome Letter”, and more.

The new version of Submission Processing is described in this manual and is controlled by the property shown below in System Configuration > System Default Settings.

To revert to the previous version of Submission Processing, set the property to no.

The Submission Correspondence tab is unique in that it will always display, regardless of review status. Clicking this tab will open a second browser window displaying the correspondence related to the submission. The two windows are linked to enable users to view and create correspondence while continuing to process the submission.

Submission Header

The header shown above is visible on all submission processing pages, and includes the following information about the submission under review:

IRB Number — If no IRB number is assigned, the Study Number displays here

PI — (Primary) Principal Investigator name

Type of Submission — Submission type (e.g., Initial Review, Adverse Event, etc.)

Reference Number —Submission reference number

Common Rule – Displays which common rule the study falls under

Study Title — Full title of the study; scroll left or right if necessary to view the full title

Study Status — Status is set to “Pending – Submitted for Initial Review” when the Initial Review form is first received by the IRB; status is updated as the submission moves through the review process

Expiration Date — Study expiration date (where applicable)

Study Menu Bar — The menu bar near the top of the page includes four tabs: Protocol Items, Miscellaneous, Submission Forms and Additional Attached Forms, corresponding to the sections of the Study Management page.

Concurrent Users on the Same Tab

If multiple users attempt to access and edit the same tab in Submission Processing, the second user will receive a message as shown below, indicating that the page is currently being edited by another user and is only available in read-only mode.  

Once the first user has navigated away from this tab, the second user will receive the message below, indicating that the tab is available for editing and needs to be refreshed.

This functionality will prevent concurrent users from overwriting each other’s changes in Submission Processing.

Saving Changes in Submission Processing

Most of the processing sections are completed within popup windows or forms and will be captured when you save your content. However, there are several panels that will prompt the user with a Save button if changes are made outside of a popup window or form. An example is shown below.

If you do not click Save Submission Discussion and attempt to navigate to another tab, the following message will warn you that changes are pending and have not been saved.

Clicking Confirm will take you to your desired location without saving those changes. Clicking Cancel will keep you on the tab to allow you to save your changes.

Clicking on the Back button in iRIS™ will have the same effect as navigating to a different page, with this message at the top of the browser.

Click on Leave to abandon your changes or Cancel to go back and save your changes.  

Submission Details

The first tab of the new Submission Processing navigation pane is Submission Details. This tab is comprised of the functionality of the legacy “General Information” and “Submission History” tabs along with several new additions. Hovering over the Submission Details tab displays the following submenu.

This allows the user to quickly navigate to each section of the tab without scrolling through the page.

A Save Changes button may appear if changes are made to an individual processing panel, as shown below.

Note that clicking Save Changes here will only save those changes made to the “Stipulations with the responses from the previous submission” panel, no other panel on the page.

Submission Review Status

The Submission Review Status panel is a new feature that displays a series of steps in the review process to give the user an at-a-glance view of where the submission is in the process. These steps are configurable by both board and review process. As each step is completed, the bar below will change from grey to green, indicating that the step has been completed.

This panel will display at the top of each submission processing tab. Clicking the icon, will collapse the panel.

Clicking the expands the panel. This behavior applies to all new submission processing panels.  

If a submission has been associated with multiple boards and/or committees, an additional panel will display with that information as shown in the screenshot below. Clicking on the board/committee will take the user into submission processing as viewed by that board/committee, provided they have sufficient access.

Please see the IRB Assistant RBA manual for more information on how to configure the Submission Review Status graphic.

General Information

The General Information panel displays basic study and submission information.

The Codes functionality will also display here to notify the user of any special flags.

The Master Lay Summary and Submission Summary from the submitted study application are also made available here, if configured.

Click the Edit the Master Lay Summary or Edit the submission summary button to add a summary to the applicable document.

Enter the desired summary text. Click the Apply button to save changes and close the popup window. Please note that no Save Changes button will appear as these changes were made in a popup window and saved once Apply was clicked and the window was closed.

Department

The Department panel will display the department(s) associated to the study as shown below.

This information is pulled from Section 2.0 of the study application Study Shell.

Study Personnel 

The Study Personnel panel displays the Role, Name, Account Status, COI Under Review status (where COI features are in use), and Training (where configured) of all personnel listed on the study.

Click the icon to the left of a user’s Name to open that user’s profile information as shown in the screenshot below.

If the Conflict of Interest (COI) module is in use, the users’ COI review status is included. Hover over the icon in the COI Under Review column to view additional information about the corresponding user’s COI status.

Click the Update personnel status to the latest button to refresh the data.

Training status may also be visible for each user if configured.

COI Status 

If using the Conflict of Interest (COI) module, review board members can view COI information for each of the covered persons on the study via the COI Status panel. This table is configurable, and each column can be activated or deactivated to provide as detailed or general information as the review board wishes.  

Clicking on the sign under View Conflict Matches will display each conflict match and its status as shown below.

If a management plan is in place, and the user has been granted access, a button will display allowing the review board member to view the management plan.

Note that this panel will only display if COI Assistant is active in your system and the pertinent properties have been turned on.

To learn more on the configuration of this functionality, please see the Review Board Administration manual.

Submission History

The Submission History panel displays the history of the submission as it has been processed through multiple boards/committees and rounds, as applicable. Users can also route for additional signoffs from this panel, if configured.

Adding Additional Users to Submission Signoff

The Add Additional Signoff button on the upper right corner of this panel enables board members to add additional users to the submissions signoff routing list. Note that this button is property controlled and may not appear in your system. Please contact your System Administrator for more information.

Clicking Add Additional Signoff redirects the user to the following screen.

The user then clicks the Find button to select the person that must sign off on the submission. Clicking Find opens the “user search” page shown below.

Here the user can search for the desired signee using the Last Name, First Name, and by Department filters. Once the desired user is found, they may be selected by clicking the icon as shown below.

This will return the user to the previous additional signoff page with the selected signee populating in the Name field as shown in the screenshot below.

A role can then be assigned to the signee via the Role dropdown. Once all fields have been completed, the user can save the additional signoff by clicking Save signoff. This will return the user to the Submission Details tab of submission processing and send an Additional Submission Signoff task to the selected signee.

Returning to the Submission History panel and viewing the most recent review board activities will display the additional signoff request.

Clicking Pending Signoff will open a read-only view of the signoff page.

Pre-Submission History

Pre-submission details can be viewed by clicking the icon as shown below.

Clicking View Signoff Routing opens a read-only version of the routing list setup window that is used on the study-side to configure the signoff routing list for submission forms.

Clicking View Signoff redirects the user to a read-only version of the submission’s signoff page as shown below.

Clicking the Back button takes the user back into the Submission Details tab of submission processing.

Review Board History

Back on the Submission History panel, clicking on the icon for a review board/committee will allow the user to view detailed information regarding the submission as well as the review process assigned, review outcome, and outcome letters from the board/committee as shown below.

Stipulations History

When a submission is returned to the study team for corrections, any stipulations created are added to the Review Response Form. The Principal Investigator or designee addresses the stipulations within the Review Response Form. When required changes are complete, the study resubmits the form to the board.  

Study team responses to stipulations populate in the Stipulations with the responses from the previous submission panel of the Submission Details tab as shown below.

Board members can then use this panel to review stipulation responses and either close/accept or reject them. If a stipulation is rejected it can be copied into a new stipulation to be routed back to the study. This new panel enables users to view study-side responses to stipulations from previous rounds without having to navigate to a different submission processing tab.

Click the icon in the Edit column to open the Process Stipulation page.

To address the stipulation response, choose a Review Action and provide a date that the response was addressed in the Date Closed field. The date is only required if the response is closed.

Click the Add Memo button to open the Stipulation Memo page below. Enter the desired memo text and click the Save button to save the memo and close the page.

The memo record is added to the Process Stipulation page. From here, memos can be added, modified, or deleted. Click the Save Stipulation button to return to the Submission Details processing tab.

Back on the Stipulation tab (shown below), changes to the Review Action and Date Closed can be made for each stipulation.

If the Review Action is set to indicate that the stipulation is not accepted, once the page is saved the system copies that rejected stipulation into a new stipulation record to be returned to the study.

You can also set the Review Action for all stipulations at once. The selection made in the Review Action column header is applied to all stipulations in the table.

After a Review Action is selected in that header, the Date Closed column header populates a field for entry of a closing date for the stipulations. If no date is entered, the system defaults the field to today’s date. Stipulations marked as “Accepted” are closed in the system.

Changes made to a stipulation can be viewed by clicking on the View Stipulation Component icon (far right column in screenshot above). A separate window opens, displaying the applicable section of the component that was changed.

Submission Components

The Submission Components tab provides pre-review access to submission form(s) and any associated documentation attached to the submission. This tab also provides access to submissions returned to the board with corrections, for viewing and comparison against previous versions (where applicable).

Four possible groups of items may populate as part of the submission package, depending on how the study completed their application and submission forms.

Top Level Submission Form(s) — in the example shown above, the Initial Review Submission Form is the top-level form, or parent form for the submission. All of the following items are enclosed within the Initial Review Submission Form as attachments:

Application —main application form; only displays if it was attached to the parent submission form

Consent Form(s) —consent forms attached to the parent form

Document(s) —additional study documents attached to the parent form; additional study documents may be further categorized within this group

Folder View vs. List View

The Items in View button in the Display Submission Components section toggles between Folder View and List View.

Folder View

Folder View lists all submission components regardless of the round in which they were submitted. Any item with more than one version displays a folder icon in the Revisions column.

Click the folder to view previous versions. Use the Compare option to compare different versions. Click the plus sign in the More Details icon to expand initial submission details for each item.

List View

List View displays submission components by submission round. The round number is incremented by one each time a submission is returned to the study for corrections. Any submission can be sent back to the study team for changes as many times as necessary, meaning that a submission can have an unlimited number of rounds.

The study team may revise or add attachments in response to stipulations, creating new submission items for review each round.

With List View, it is possible to filter submission items by round number via the Show submission component(s) in round field (see red box in screenshot below).

When the button is first toggled to Items in List View, the display defaults to showing the submission components for the current round. The Compare option is not available in this view as only documents for a single round are displayed.

It is also possible to combine all rounds into a summary view (shown below). Select “All Rounds” in the Show submission component(s) in round field to display all components associated to the submission for all rounds.

Document Versions

When a new submission is processed, its attachments are versioned x.0, where x denotes the user-defined version number at the time of upload to the system and 0 denotes the incremented system-defined version number of the document.

When a revision is created the .0 number is incremented by one. For example, when a revision of document version x.0 is created, a version number of x.1 is assigned to the revision.

The Revisions column populates with a folder icon (when in Folder View). Click the icon to expand the component record to show all past versions of the document or form.

The review board may create revisions of submission components once per round by clicking the icon in the Revise/Attach column. Note that the revise icon is only displayed for the highest version number submission attachment.

Click the icon next to the desired component; a popup window prompts the user for confirmation of the revision.

Click CONFIRM to proceed. When the revision is complete, the icon no longer appears in the Revise/Attach column as only one revision is allowed per round.

If the study team has made a revision of a submission component that has not yet been submitted to the board, a icon appears in the Revise/Attach column. This icon only displays if the attached revision of the document is still editable.

The board can now attach the latest, study-created version of the item to this round of the submission. Click the paper clip icon to open a window to select the item version that will be attached to the submission.

Click the icon in the Select column to select the desired version and attach it to the submission components. It is not possible to revise this component in this submission round.

Viewing Submission Items

The name of the submission component and version number display in the Current Submission Rounds column. Click the name of an item to open and view that item in the same browser window.

The form or application is opened for review, as shown below.

Clicking Back returns the user to the Submission Component(s) tab of submission processing.

Click the icon in the View in Separate Window column to open the item in a new tab or window.

Viewed submission components are highlighted with a shaded background. Submission components not yet opened remain un-highlighted.

Reset highlighting of viewed forms and documents by clicking the Clear Viewed Item(s) button above the submission components table.

When a consent form or other study document is opened, review board details about that document are displayed in a popup window, as shown below.

In addition to the standard document metadata fields, three board-specific options are displayed: Consent Outcome, Review Board Approval Date, and Review Board Expiration Date. These can be used by board members to approve, acknowledge, or void the document.

Commenting on Submission Items

Comments can be added to any questions in the submission form and the first three sections of the application. Comment-enabled questions are designated with a icon in the far-right hand column of the question display, as shown below. Click on the icon to add a comment.

The Reviewer Comments Editor popup opens, providing a text editor to enter desired comments. Click Save Comment to save comments and close the popup.

Questions with comments added are updated with a green highlight behind the comment icon, as shown below.

Modify or remove comments by clicking the icon again. Note that a time-date stamp and the author name are displayed for existing comments in the Reviewers Comments Editor popup.

Select the Display my comments to other reviewers checkbox to make the comment entered here visible to other reviewers. Leave the checkbox deselected to keep the comment private to the person who created them.

Commenting is also available for consents and other study documents.

When viewing the document as shown above, toggle the On button for Highlight Comment Mode to open another window with a highlighter feature enabled.

Click and drag to select a word or phrase in the document, highlighting it yellow. A small popup window appears for entry of a comment. When changes are complete click the Save button to save the comment to the document.

The comment is added to the document and appears at the bottom of the window. Edit, Reply, and Delete options are available for comments, as shown in the screenshot below.

A link to the comment is also added to a summary table of comments under the Highlight Comment Mode button in the Comments column.

The summary table includes options to delete the comment, hover over the comment link to view its text, or click on the comment to reopen it in the text editor popup window.

Comments added to forms and documents can later be merged into stipulations.

Viewing Additional Submission Item Details

Back in the Display Submission Components panel of the Submission Component(s) submission processing tab; click the plus sign icon in the More Details column to expand a specific submission item’s details.

Submission date and timestamp details are shown for all submission rounds of the item.

Where applicable, other study documents include associated approval information.

Comparing Submission Items

A Compare Item(s) button is provided in the Display Submission Components section of the Submission Component(s) submission processing tab. This tool is only enabled when multiple versions of the same item exist for comparison.

Recall that if multiple versions of a submission item exist, they are grouped in a folder. Click the button to right of the Compare Item(s) button to toggle between List View and Folder View. Folder View is the default. Note that button text updates to show the view option not currently in effect, i.e., Items in List View means that the components are currently displayed in Folder View.

Only items of the same type can be compared (e.g., application to application, study document to study document).

Select the checkboxes in the Compare column of the items to be compared and click the Compare Item(s) button.

Attach New Submission Components

Click the Add New Component button in the Display Submission Components panel to add consent forms or other study documents to the active submission.

The Select an Attachment Type window will open prompting the user to select which type of attachment they would like to upload.

Consents

If “Informed Consent” is selected in the Select an attachment type popup, the user is directed to the list of submitted consent forms on the study. Any consent that has already been attached to the submission will be indicated by an Already Attached label in the first column.

Here the user can attach a new revision of the consent, copy approved consents, or add a new consent by clicking on Add Consent.

Clicking on Add Consent will display the window below, allowing the user to revise an existing consent or upload a new consent by clicking on Upload a New Document Not on the List.

Clicking Upload a New Document Not on the List opens the following window.

After entering the information, click the Save Consent button to return to the list of consents on the study.

The new record is added to the list, indicating the consent has been attached to the submission.

If the option to revise an existing consent form record is selected, the chosen form is opened for revision and optional check out in the Study Consent Revision window. Click the Save Consent button to save the revision and close the Study Consent Revision page.

The new revision is added to the list, indicating that the consent is attached to the submission. Note the indicator that the revision was created by the board. 

Study Contracts

If “Study Contract” is selected in the Select an attachment type popup window, the user is directed to a list of previously submitted contracts on the study. Any contract that has already been attached to the submission will be indicated by an Already Attached label in the first column.

Select one more existing contracts and click Attach to attach them to the current submission or click Add a New Contract to attach a new contract document. Attaching a new contract will open the Study Contract Add window.

Completing the fields in the window above and clicking Save Contract will close the window and attach the new document to the submission.

The new contact will then populate in the Display Submission Components panel.

Other Study Documents

If “Other Study Document” is selected in the Select an attachment type popup, the user is directed to a list of submitted documents on the study. Any document that has already been attached to the submission will be indicated by an Already Attached label in the first column.

From this window it is possible to attach/revise an existing document from the library or add a new document.

To add a new document, click on the Add a New Document button and the following screen will open, allowing the user to revise an existing document or click on the Upload New Document Not on the List button to upload a brand-new document.

Clicking the Upload New Document Not on the List button will display the following window.

Once the document is saved it will appear in the Display Submission Components panel as shown below.

Create PDF Packet

Multiple submission components can be bundled and printed to PDF-format “packet”.

Select the checkboxes in the Include in PDF Packet column for items to be included in the PDF, then click the Create PDF Packet button. This opens the Reorder PDF Packet popup window below.

Rearrange items shown in the list as desired by clicking a line item, holding the mouse button down, and dragging the selected item up or down in the list. Release the mouse button to confirm the new location.

Once the item order is satisfactory, click the Generate PDF Packet button.

The PDF packet is generated and opens in a new window. From the new window, the document can be printed or saved as a downloaded file.

Approve Attachment(s)

Documents can be approved individually by clicking on the document title in the Submission Components page, then completing approval steps in the document details.

Multiple attachments can be approved in bulk for the submission via the Approve Attachment(s) button.

Clicking the Approve Attachment(s) button opens the Submission Attachment(s) Approval page (shown below), where all consents and study documents for the submission are listed.

Click to select the applicable checkboxes in the far-left column for all items to be approved. Click the select icon in the column header to select all checkboxes in the column.

After selecting the applicable checkboxes, specify a review outcome for each item in the Review Outcome column. Click the select icon in the column header to set all Review Outcome fields for the selected items to “Approved”.

Use the calendar widget in the Approval Date column to select an approval date for each approved item. Repeat this process to assign an Expiration Date (if applicable) to each item.

Note that the Expiration Date field may be disabled depending on your system configuration. If the field is disabled, the Expiration Date column still displays but does not contain calendar widget controls and date fields.

Once all approval information is entered, click the Apply button. The system converts the approved item to a PDF and stamps the document with the board’s study document approval stamp. A PDF file of the approved document is accessible via a PDF icon in the Stamped column of the Submission Attachment(s) Approval window.

A note that the item is approved, and its approval date (where applicable) is added to the display of all approved documents (blue text in screenshot below).

View in Separate Window

The View in Separate Window column of the Display Submission Components tab allows the user to view a submission component in a new browser window while continuing to view the submission in the original window.

Click the icon in the View in Separate Window column view the item.

The selected component is opened in a separate window as read-only (shown below).

Compare to Last Approved

The Compare to Last Approved column of the Submission Components tab provides a tool to compare the last approved version of an item with the latest version. Click the icon in the Compare to Last Approved column to open the side-by-side comparison panel.

The two versions of the document, last approved and most recent, are shown side by side in a separate browser window. Beneath the side-by-side section, modifications are shown in a Details of Changes panel. Additions are shown in green, and deletions are shown in red.

Pre-Review Screening

The Pre-Review Screening tab is used to assign the analyst, complete the analyst checklist, process the submission (i.e., assign a review process, add the submission to a meeting, designate a committee), and assign reviewers.  

The first panel on this screen is the Submission Review Status graphic that displays the current progress of the submission. This panel appears at the top of every submission processing tab.

Assign Analyst

From the Analyst Assignment panel, the user can assign an Analyst to the submission. The role of the Analyst is to provide and/or coordinate comprehensive technical and compliance pre-review of study submissions.  

In the upper righthand corner of the panel is a View Analyst Workload button. Clicking this button allows the user to view the workloads of all available analysts prior to assignment as shown below.

Click the folder icon to show all assignments for the member. Click the Print button to print the list of assignments. Click the Close button to close the window.

The user assigned as the Analyst receives homepage tasks related to the submission until the submission form is closed. The Analyst also receives submission-related notifications (e.g., Reviewer Complete Notifications, Outcome Letter Signoff Complete Notifications, Review Response Complete Notifications).

When an Analyst is selected or a change is made, a Save Changes button will appear in the upper right-hand corner as shown below.

Click the button to save any changes made.

Analyst Checklist

Once an Analyst is assigned, the user will receive an Analyst Assignment task on their homepage as shown below. The user will also receive an email notification regarding the assignment sent to their email address on file for notifications.

Clicking on the task will take the user to the Submission Details tab to begin their review.

Once they click on the Pre-Review Screening tab, they will have the ability to create an Analyst Checklist from the Analyst Checklist panel as shown below.

Clicking the Add Analyst Checklist button will open a new window displaying their checklist.

This checklist can be customized using the System Form Designer and can include similar data values to a reviewer checklist. Please ensure that the “Analyst Complete” data value is included in the form as the last section.

Any comments entered into the submission components or into the form will flow into the submission’s Review Summary. These comments can then be merged into stipulations, the review discussion, and outcome letters.

Multiple Analyst Checklists can be created for cases where a new Analyst has been assigned. Click on the Add Analyst Checklist button to add additional checklists for the submission.

To remove an Analyst Checklist, click on the delete icon inside the Remove Analyst Checklist column.

IRB Number

If the review board number is not automatically generated by the system, this panel will allow the user to manually enter or generate a tracking number for the study. Please note that this panel may or may not display depending on your system configuration.

Note that the visibility and editability of this panel is property dependent. Additionally, the auto-generation of review board number is configurable via the Review Board Administration > Setup Study Numbering link. If study numbering is turned off, submissions will not be automatically assigned a review board number upon receipt by the board. The board must then ensure that the property controlling the board number editability is configured to allow board members to manually enter in a number for each submission.

Best practice is to configure the system to automatically assign a pre-defined review board number to each submitted form.

DMR/FCR Polling (IACUC Only)

The next panel enables the Analyst to route the submission for a vote on whether the submission should undergo a full committee review or if it can be assigned Designated Member Review. This functionality is only available in the IACUC module and is property-based.

Clicking on the DMR/FCR Polling link will take the user to the panel shown below.

When the user clicks on the Send for DMR/FCR Polling button, a task will be sent to all members of the IACUC board that have a role with the property “Include in DMR/FCR Polling” set to yes, as shown below. This is configured in the Setup Review Board Roles in IACUC Review Board Administration.

Once the button is clicked, the display within the panel will change to include the date and time the tasks were sent for polling. In addition, the Polling Completion field displays how many members have completed their tasks as shown below.

The voting time period can be configured in the IACUC Review Board Administration area and will drive a notification to the Analyst when the polling time period has expired. The words Polling Time Expired will also appear in the DMR/FCR Polling panel as shown below.

The task the user receives is shown below and allows the user to review the submission and vote on whether the submission can undergo a Designated Member Review or should undergo a Full Committee Review.

Please note that the date and time of the Polling Period deadline is displayed in the description of the task and on the task screen.

Clicking on the open icon will take the user to the screen below.  

Once the user completes their review of the submission, they can vote and include any comments they would like to make on the submission. To complete the vote, the user must click on Submit Vote. Results are recorded on the next panel, DMR/FCR Polling Results.

DMR/FCR Polling Results (IACUC Only)

The next panel displays the status of each of the recipients of the DMR/FCR Polling vote. This panel will appear once the Send for DMR/FCR Polling button is clicked in the previous panel.  

If no members have submitted their DRM/FCR vote, this panel will display as shown below.

As members complete their DMR/FCR polling task, their vote and any comments made will populate in the panel. These members will also be highlighted in green as shown in the screenshot below.

Determine Review Process

The next panel enables the Analyst to select a review process and associate the submission to a meeting, as necessary. Please note that these review process names are configurable by board in the Setup UI Content area of System Administration 🡪 List Configuration and Maintenance. In addition, review processes are configurable and can be turned on and off via Review Board Administration 🡪 Board Configuration Options.

The following review processes are commonly used in iRIS™ review boards:

Not Assigned - the submission defaults to this selection when first submitted; this selection indicates a review process has not yet been assigned.

Full Committee Review – this selection indicates that the submission is to be processed via a full board review; when this option is selected, committee and meeting fields are displayed.

Expedite – if this item is selected the Analyst can then select reviewers if applicable

Designated Reviewer – if this item is selected the screen refreshes with the option of assigning the submission to a meeting date. Designated Reviewers and Designated Members may be assigned in the next panel

Exempt - if this item is selected the Analyst can then select reviewers if applicable

Pre-Review changes requested – this selection sends the submission back to the study for pre-review corrections

Process Administratively – this selection indicates that the submission is to be processed through the board but not subjected to full board review

Once you have selected a review process, make sure that you click on the Save Changes button in the upper right-hand corner of the panel to assign the process to the submission.

After selecting and saving a review process, two additional submission processing tabs will appear, Submission Review and Submission Outcome, as shown below.

Review Fee

This option is used for IRB invoicing and may not be configured in your system; for more information see the IRB Assistant - Invoicing manual

Assign Reviewers

The Assign Reviewers panel enables the review board coordinator or analyst to add reviewers to the submission. A Member section also is shown in the screenshot which will only appear when the review process is set to “Designated Reviewer”.

Notice that the only difference between the two reviewer tables in the screenshot above is that the upper table, for non-board members, includes a Specialty field. Apart from this field, the data captured for reviewers is the same in each table.

The processes of adding board member and non-board member reviewers are very similar as well. The steps to add a non-board member reviewer are detailed below.

Click the Add Reviewer button (Add Member button for a board member) and the following popup window will display.

Configure the reviewer using the dropdowns and click on Save to save the assignment.

The Assign Reviewers panel will refresh, and the reviewer will be added to the list.

If “Ad Hoc” is selected for reviewer role, the popup menu will change and give the user the option to add someone not on the list to conduct a review of the submission.

Repeat this process to add as many reviewers as are needed.

To delete a reviewer from the list, click the delete icon in the far-left column for the applicable user. A confirmation popup displays to confirm the removal; click the CONFIRM button to proceed or the CANCEL button to cancel the process.

Assigned reviewers receive a notification advising them that a submission is awaiting their review. The review assignment also appears as a task on their home screen.

If the selected review process is “Review Committee Agenda”, the reviewer will not receive a notification until the Coordinator enables reviewer notifications for the applicable meeting date.

The Analyst may also be added as a reviewer by clicking on the Add Analyst as Reviewer button and following the same steps described above for non-review board member.

Comments to Reviewers

Analysts can also enter comments for the reviewers assigned to a submission. Once one or more reviewers have been assigned to the submission, the Add Comments for All Reviewers button will appear. Clicking this button will open the following text editor window.

Once the Analyst adds and saves comments for the reviewer, the button text changes to View Comments for All Reviewers. Click this button to view or modify the comments.

Reviewers Workload

To check the workload of a board member before assigning that member to review a submission, click the View Reviewers Workload button. This will open a separate browser window displaying each board member’s reviewer assignments.

Click the folder icon next to a member’s name to show all assignments for that member. Click the Print button to print the list of assignments. Click the Close button to close the assignments window.

Submission Review

The Submission Review tab contains a set of tools and data that enable Analysts and Coordinators to complete their submission reviews. This tool and data set includes information from the reviewer and member checklists, member comments, reviewer summaries, the submission discussion, recommendations, etc. The exact panels that populate in this tab depend on the configuration of the review board and the review process assigned.

Remember that the Submission Review Status graphic may be review process-dependent and may differ from the example used in this document once a review process is assigned.

Reviewer Check List

The Reviewer Check List panel displays the status and details of reviewer tasks.

Contents of the View/Edit column varies according to review status and by logged-in user.

If the reviewer has not yet started their review, the column contains text indicating the form has not been started yet.

If the review is in-progress, the column displays an open book icon.  

If the logged-in user is assigned as a reviewer, the column displays a pad and pencil icon. The user can click this icon to open their reviewer checklist.

The other columns in the table are:

Reviewer Role — Role of the reviewer

Reviewer — Name of the reviewer name

Completed? — Review complete status, displays “Yes” or “No”.

Date Notified – Date the reviewer was notified of the review assignment

Date Completed – Date the reviewer completed the review and the review Completed? status was set to “Yes”

Share Review with Other Review Boards — Click the button in this column to share the review with other review boards. This opens the panel shown below, where available review boards are listed.

Click the applicable checkboxes next to the boards that should receive the review and then click the Save button.

Member Check List

Any member of the review board can complete the same checklist form used by assigned reviewers.

Click the Add Member Checklist button in the Member Check List panel (shown in screenshot above) to open the Reviewer Checklist form in a new window.

The board member can complete as much or as little of the form as they wish, there is no requirement for completion. When the board member returns to the Review Checklist and Comments tab, the Member Check List table populates with their entry. The member can click the Edit icon to open their checklist.  

Member Comments

Any board member with appropriate access can add comments to the submission using the Member Comments panel shown below.

Click the Add Member Comments button (shown in screenshot above) to open the Member Comments window.

Select the Display my comments on the review checkbox to make the comments visible to all board members.

Select the Display my name with the comments checkbox to include the author name on comments made visible to all board members. If this checkbox is unselected, the comments are posted anonymously.  

Click the Save button to save the comments and return to the Submission Review tab.

If a comment is posted anonymously, only the user who added the comment can see their name displayed on this page.

Review Summary

The Review Summary panel will display items that have been added to the Discussion, Outcome Letters, and Stipulations. Initially, the Review Summary panel will be blank, but once items are added to these three sections they will begin to populate here.

Clicking Edit / View Review Summary will open a popup window displaying all comments and checklist answers made by analysts, reviewers, and board members.

From this window, these items can be merged into the Submission Discussion, an Outcome Letter, or a Stipulation by clicking the appropriate checkboxes as shown below.

Select the checkbox(es) in this column to specify items to be merged into the Submission Discussion, the next panel on the Submission Review tab; typically, any item that should be flagged for review at the meeting is merged into the Submission Discussion.

Select the checkbox(es) in this column to specify items to be merged into an Outcome Letter when it is later generated; any item that should be communicated to the study in the formal letter is merged via this selection.

Select the checkbox(es) in this column to specify items to be merged into a Stipulation; any comment that originated from a submission item that is then merged into Stipulations will link the Stipulation to that item in submission components (see Stipulation section of this manual).

Once you have selected all items to merge, click on the Save the Selection button. The Edit Review Summary window will close and the items that were selected will now populate in the Review Summary panel as shown below.

Click on the Edit/View Review Summary button to include additional items or to remove items.

Merged Items

Items merged into the Submission Discussion will populate in the Submission Discussion panel text editor once saved, as shown below.

An item that was selected to be merged into Stipulations will populate in the Stipulations to be sent for Response panel as shown below. Notice that the stipulation record includes a green-highlighted link icon in the Link To Component column indicating that the comment is associated to a specific section of a submission component.

Submission Discussion

The Submission Discussion panel is used to capture information related to the submission, such as notes from the Analyst or any discourse on the submission that takes place during a meeting. Items from the Analyst Checklist and Reviewer Checklist(s) can be merged into the Submission Discussion text editor. This Submission Discussion panel content can then be merged into letters and meeting minutes.

If changes are made within the text editor, a Save Submission Discussion button will appear in the upper right corner of the panel.

Please make sure to save any changes made as you browse through the different panels on this tab.

Recommendation

The Recommendation panel is used to create and maintain board member recommendations.

Click on the Add a new Recommendation button to display the Add Recommendation text editor in a popup window as shown below.

Click the Save button to save the recommendation. The Recommendations panel will refresh to display the new changes.

These recommendations can then be merged into letters and meeting minutes.

Note: This panel is property-based and may not display in your institution’s instance of iRIS™.

Stipulations

The Stipulations to be sent for Response panel is used to manage and create submission stipulations.

Initially, only stipulations that have been merged from the Review Summary panel are displayed. In the example below, no items were merged so no stipulation records are shown.

The columns in the stipulations table above are described as follows:

Delete — click the icon in this column to delete a stipulation

Edit — click the icon in this column to open the stipulation for editing

Sorting Number — stipulation priority order

Stipulation Type — type selected for the stipulation; three options are available: Stipulation must be addressed, Comments that must be addressed, and Comments

Follow-up Due – displays the follow-up due date for Comments that must be addressed stipulation types, displays “N/A” for other stipulation types

Stipulation — stipulation content

Requested By — the creator of the stipulation as well as the last user to edit the stipulation

Link to Component – linking indicator for associated components; includes either “Click to link” button if no component is linked or a color-coded link icon if an associated component exists

Add a New Stipulation

To add a new stipulation, click the Add New button (shown in screenshot above). This will open the popup shown below.

There are three steps to adding a stipulation:

1. Select Stipulation Type 
2. Associate components to the stipulation (optional)
3. Enter stipulation content

Click the Stipulation Type dropdown menu to select a stipulation type. iRIS™ provides three options:

Stipulation must be addressed — A required change requested by the review board; this stipulation must be addressed before any further action can be taken on the submission

Comments that must be addressed — Any stipulation or recommendation from the board that can be addressed separately from the submission approval criteria. These stipulations require a follow-up due date to be entered via the Follow-Up Due field as shown below.

Comments — general recommendations entered by the board; require no action from the study team

To associate components to the stipulation, click the Attach Component(s) to the Stipulation icon/link in the left-hand sidebar.

The following window will open, along with help text on how to associate a component to the stipulation.

See the “Associating Components” section of this manual, immediately following, for more information about associating components.

Enter the desired Stipulation Content and click the Save button to add the stipulation to the submission.

Once added, the stipulation will populate in the stipulations table as shown below.

Associating Components

When adding a stipulation to a submission, users can associate the stipulation to a specific submission component. Doing so will redirect the study team to the specific associated component when they begin to address the stipulation.

To associate one or more components to the stipulation, click the Attach Component(s) to the Stipulation icon/link in the left-hand sidebar.

The Associate Submission Component(s) to your Stipulation popup opens.

Three buttons are available in this window:

1. Associate Component Removal — used to communicate to the study team that a specific document needs to be removed from the submission; click this button to open the panel shown below listing all existing submission components

Select the radio button for the component(s) to be removed, then click the Add Link to Selection button (shown in screenshot above).

The popup closes and the “remove attachment” request is added to the component table, as shown below. If the request was created in error, click the icon in the Detach column to delete the record.

2. Associate New Component — used to communicate to the study team that a specific document needs to be attached to the submission; click this button to open the panel shown below

Select the radio button(s) for the component(s) to be added, then click the Add Link to Selection button (shown in screenshot above).

The popup closes and the “add attachment” request is listed, as shown below. If the request was created in error click the icon in the Detach column to delete it.

3. Associate Existing Component — used to communicate to the study team that a previously associated document requires modification; click this button to open the panel shown below

Select the radio button(s) for the component(s) to be added, then click the Add Link to Selection button (shown in screenshot above).

The popup closes and the “modify attachment” request is listed, as shown below. If the request was created in error, click the icon in the Detach column to delete it.

When all component associations are complete, click Done. The popup closes and the Review Stipulation page is updated with the associated component request details.

Click the Save button in the bottom right-hand corner to save the changes to the stipulation. Stipulations associated to one or more components are designated by a green-highlighted link icon in the Link to Component column.

Add Multiple Stipulations

Users may add multiple stipulations at once by clicking on the Add Multiple button in the Stipulations panel.

This will open the Add Multiple popup window shown below.

Using the Content text box, a pre-existing list of stipulations copied from an outside source, such as a Word document, can be pasted into the window. Each line of text corresponds to one added stipulation. Select a Stipulation Type and click Save to add the stipulations to the study.

Add Pre-Defined

Click the Add Pre-defined button to add one or more predefined, or “canned”, stipulations. A popup window containing a list of available canned stipulations opens. Click to select the checkbox(es) of the stipulation(s) to be added, then click the Save button to add the predefined stipulations to the submission.

Each pre-defined stipulation is added to the submission as an individual stipulation record, shown below.

Merge From Review Summary

Comments in the Review Summary panel can be merged into the Stipulations tab.

To merge any Review Summary item into a Stipulation, select the appropriate Add to the Stipulations checkbox and click the Save the Selection button to complete the merge.

Note: If “Comments from the Submission Components” are merged into the stipulations, the links to corresponding components are merged as well.

The selected stipulation(s) is/are added to the Stipulations to be sent for Response panel as shown below, each as a separate record.

Internal Review Routing

The Internal Review Routing panel is used by review board Analysts to route the submission internally. This can be useful, for instance, when sharing the submission with a Chairperson or specialty reviewer.

The Internal Review Routing panel contains a table that tracks the internal routing history. Using the tools provided in this panel, board members can create or modify a routing list for the submission, add comments/notes for the new recipients, and send the submission. In the screenshot above, no submission routing has occurred.

To begin the internal routing process, click the Edit Internal Routing button.

This will open the following popup window.

Click the Assignment notes link to create a note for the routing of the submission. This will open a text editor popup as shown below.

Enter the desired routing notes and then click Apply.

The added notes will populate in the Assignment notes field as shown in the following screenshot.

To add a new routing assignment row to the table, click the Add Review Board Routing button and select a member from the dropdown list (shown below).

To add a non-board member user, click the Add Non-Review Board Routing button and the Search User window will open, enabling system user lookup.

Users added to the routing are listed in the order they were added, as indicated by the Order Number column. To re-order the users simply change the numbers in this column. If two or more users in the list are given the same Order Number, they will receive the submission at the same time.

To add a reviewer-specific assignment note to the routing, click the Assignment Comments button above the corresponding user’s name. The following text editor will open. Enter the desired assignment notes then click Apply to save the comment.

Assignment comments will populate in the user’s assignment record as shown below. These comments will not be visible to any other users in the routing list.

Repeat the above process to add additional users to the routing distribution list.

Once the routing list configuration is complete, select “Yes” in the Have you completed your selection of required routings? field and click the Save button at the lower right-hand corner of the window as shown below.

Upon clicking save, the submission is distributed to each user defined in the internal routing list beginning with the Order Number 0. As each user receives and completes the routing task, the next user in the routing list is notified until all reviews are complete. Users assigned the same Order Number are notified at the same time.

Note: If a user who has already received the submission is deleted from the system, routing continues with the next user, in ascending order.

As routing recipients open and complete their review tasks the Internal Review Routing panel will update accordingly. Additional users can be added to the routing by clicking on the Edit Internal Routing button.

Vote / Expedited By / Acknowledged By

The review process assigned to the submission dictates the next panel to populate on the Submission Review tab. These scenarios are described below.

• Review process = “Full Committee Review” 🡪 Next panel = Meeting Vote
• Review process = “Expedited” 🡪 Next panel = Expedited By
• Review process = “Exempt” 🡪 Next panel = Acknowledged By
• Review process = “Process Administratively” 🡪 Next panel = Acknowledge By
• Review process = “Pre-Review changes requested” 🡪 Next panel = None (Internal Review Routing is the last panel)

Meeting Vote

The Meeting Vote panel enables the capture of meeting votes on various board-defined motions for the submission.

Votes may be captured at the time of the meeting or any time before the submission is completed.

To record a meeting vote or add a motion, click the Edit Meeting Vote button. This opens the following Meeting Motion popup window.

Click the Click here to edit Motion Content link to open the following window.

Manually enter or copy and paste the motion text into the text editor. To use a predefined motion template, select an option from the Template dropdown and click the Add Canned Language button.

In the example below, the “Full Board Approval” template language has been added to the motion.

Click the Save the Motion button to add the motion to the submission.

Note that voting members will not appear in the Meeting Motion window until meeting attendance is set. Any voting member marked as present at the meeting will then populate in the screen above.

Once a motion is defined, the member vote may be captured. In the Meeting Motion window, use the Vote column to select a vote type for each member present at the meeting. Click Save the Members Vote button to save the vote configuration.

Additional motions can be added by clicking on the Add an Additional Motion button at the bottom of the window.

The member votes in this panel may be merged into the outcome letters and meeting minutes if desired.

Anonymous Voting

Note that there are two voting configurations in iRIS™: anonymous voting and non-anonymous voting. Non-anonymous voting was displayed in the example above, where votes are linked to specific board members that are present at the meeting. Anonymous voting obscures member names and instead simply captures the number of votes recorded for each vote type. This latter configuration is shown below.

This functionality can be configured by navigating to Review Board Administration > Submission Review Properties and setting the property shown below to yes.

Expedited By

If the submission is assigned a review process of “Expedited”, the Expedited By panel will display as shown below.

Here expedited reviewers may be assigned to the submission. These expedited reviewers are added in addition to the standard reviewers assigned during the Pre-review Screening process.

Click Select Expedited By to begin adding expedited reviewers. Please note that you can filter the members by review board groups if you have configured them in your system.

Click the checkbox in the Expedited column for each user to be added as an expedited reviewer, then click the Save button to apply these selections. The Expedite By panel will then refresh to display each added reviewer as shown below.

Click Select Expedited By again to modfy the selected expedited reviewers.

Acknowledged By

The Acknowledge By panel is used to indicate board members’ approval of the submission.

The Acknowledged By panel contains a table of review board members. Signal a user’s acknowledgement of the submission by clicking the appropriate checkbox in the Acknowledged column.

Click the Save Acknowledgement by button to save the selection(s).

Submission Outcome

The Submission Outcome tab contains a set of panels that enable the finalization of the submission review process. These panels include Review Outcome, Display Submission Components, Outcome Letter, and Review Complete.

Review Outcome

The Review Outcome panel enables board coordinators and analysts to modify and finalize the status and review outcome of a submitted study.

Notice that the fields of the Outcome panel are now read-only. Rather than editing the outcome fields directly on the main submission processing page, these fields are modified via an Edit Review Outcome popup window. This window is accessed by clicking the Edit Outcome Details button (red box in the screenshot above).

The fields that populate in this window are dependent on the review process assigned to the submission as well as the system/board configuration. For example, submissions assigned a process of “Pre-review changes requested” will only contain one field in their Outcome panel, Study Status.

The most common outcome fields are described below. Remember, you may or may not have access to these in your system.

Note that portions of the Outcome panel may be shown in isolation in this manual due to the large number of potential fields.

Review Outcome

Assign an outcome to the submission by selecting the applicable Review Outcome from the dropdown list shown above.

If the submission cannot be reviewed on its assigned meeting date, select an outcome of “Tabled” and assign the submission to a different meeting for review. in this case Submission Approval and Study Status should be left as is.

If an outcome is selected that will return the submission to the study(e.g., “Pending Approval – Requesting Corrections”), the Additional Information Required field toggles from “No” to “Yes”, as shown in the screenshot below.

“Yes” indicates the submission is to be returned to the study via a correction or response form. In that case, the Submission Approval date field changes to a Follow-up Due field (shown in screenshot above). Enter the applicable Follow-up Due date by clicking the calendar widget and navigating to the desired date.

If a denial outcome is selected in the Review Outcome dropdown list (e.g., “Denied”), leave the Submission Approval date field empty and change the Study Status to a denied status type.

If an approval outcome is selected in the Review Outcome dropdown list (e.g., “Approved”) and the Additional Information Required field displays “No”, the submission will be removed from the workflow and transferred to the Completed Submissions queue once completed.

Completing an Approval Outcome

Described below are the steps needed to approve a submission in iRIS™.

1. Enter the applicable Submission Approval date and Meeting Approval Date (if the submission was not originally assigned a meeting date).
2. Select the applicable Study Status. These statuses are configurable via System Administration > List Configuration and Maintenance > Setup Study Status.
3. If the submission was assigned a review type of “Expedited”, “Exempt”, or “Administratively Processed”, the following fields are provided to assign the submission to a meeting agenda.

Committee Name – select the committee that will be hosting the meeting

Meeting Date – select the applicable full board meeting date from the dropdown list, or click the click here to select past meetings link to select a past meeting

Agenda Category – select the applicable agenda category from the dropdown list

4. Add outcome comments. As shown below, three types of comments can be entered in the Edit Review Outcome window:

Internal Comments — comments visible only to members of the review board to which the submission is assigned, will also display in the General Information section

Shared Comments — comments visible to all review boards that have access to the study

Take Note — text displayed in a pop-up window each time a submission is opened for the study; this can be used to alert interested personnel to important study or submission information

5. Complete the next section as follows. Note that the “IRB of Record” fields apply to the IRB Assistant module only.

IRB of Record defaults to “Yes” for all submitted Initial Reviews, indicating that the board processing the submission is the IRB of Record; select “No” to indicate that the review board is processing the submission on behalf of another board (the system excludes these studies from Continuing Review reporting requirements)

Is Ceded From defaults to “No”, indicating this submission is not ceded from the IRB of record. Toggle to “Yes” if the submission is ceded from the IRB of record.

Click the Please Select the Type of Review Notification that Must be Sent field to indicate the type of review notification that will be sent.

6. Complete the next group of data fields in the Outcome panel as described below.

IRB Initial Approval – enter the date that the initial review board approval of the submission was granted; the initial approval date is entered here when processing an initial review and once entered, the field becomes read-only; note that the field will change depending on the study board being used, for example if an IACUC submission is being processed this field would read IACUC Initial Approval

Review Cycle –amount of time (minus one day) between the submission approval date and the review board expiration date

IRB Expiration Date – Outcome expiration date, can be manually entered or calculated by the system via the Calculate Date button; if calculating, ensure that a Submission Approval date and a review Cycle have been selected

Note: when processing a submission that does not have an Initial Review or Continuing Review status, the Review Cycle and IRB Expiration Date fields are set to read only (shown in example below) and can only be changed through the Study Summary Profile. 

Days Prior to IRB Expiration – the number of days before the submission expiration date that a continuing review is due; the Continuing Review Due date will auto-fill based on this selection

Continuing Review Due –the date a continuing review is due; will auto-populate if a Days Prior to IRB Expiration is selected

Study Follow-up –the date a study follow-up is due

7. The following fields may or may not be applicable to the study and are optional:

Temporary Closed — set this flag to “Yes” to temporarily close the study

Temporary Closure Start — Temporary Closure Start date for studies with Temporary Closed set to “Yes”

Temporary Closure End — Temporary Closure End date for studies with Temporary Closed set to “Yes”

8. The next section in the Review Outcome panel pertains to risks assigned to the study. These fields employ new, institution-defined picklists which are configured under [Review Board module] > Review Board Administration > List Maintenance Setup.

Complete these fields as described below:

Risk Assigned — click this combobox to assign a general risk profile to the study

Adult Risk Assigned — click this combobox to assign an adult-specific risk profile to the study

Adult Benefit Assigned — click this combobox to assign an adult-specific benefit profile to the study

Pediatric Risk Assigned — click this combobox to assign a pediatric-specific risk profile to the study

Exempt – check this box to enable the study team to close their own “Exempt” study via a button in Submissions and on the Study Workspace; note that this option is property-based and may not display depending on your system configuration

9. The next group of data fields in the Review Outcome panel is shown below.

Non-Human Subject Research (NHSR) — select “Yes” to indicate that the study includes non-human (e.g., animal) subject research; select “No” to indicate the study does not include non-human subject research

Subject Approved — number of allowable subjects and/or controls approved for the submission; when Subject Management is in use, the number of approved subjects in this field limits the number of subjects that the study can enroll

Subject Justification — enter the text of the subject justification statement

Controls Approved — number of allowable controls approved for the submission

10. The next section in the Review Outcome panel covers regulatory determinations. These fields employ new, institution-defined picklists, which are configured under [Review Board module] > Review Board Administration > [List Maintenance Setup tab].

Complete the fields as described below:

Regulatory Determination 1 — click in this field to open the institution-defined picklist, then click to select the desired item

Regulatory Determination 2 — click in this field to open the institution-defined picklist, then click to select the desired item

11. The next section of the Review Outcome panel includes fields to specify the Risk Level and to select categories for the study. Click to select the desired checkbox(es) and picklist items.

12. The following sections of the Review Outcome panel cover optional categorizations that can be applied to the submission. Note that the sections, items, and item text shown in these fields can be configured when the outcome form is created and modified in the system Form Designer.

In the example screenshots included below, sections are included for Exempt, Expedited Review Category, Continuing Review Expedited Review Category, Investigational Drug Use, Investigational Device Use, Documentation of Consent, Waiver of Consent, HIPAA, Children Risk Assessment, Assent, Parental Permission, Wards, Pregnant Woman/Fetuses/neonates, Prisoners and Problem/Deviation/Noncompliance. Please note that the language displayed is configurable via System Administration 🡪 List Configuration and Maintenance 🡪 Setup UI Content. In addition, some sections may be hidden depending on your system configuration.

Clicking on any of the N/A checkboxes will hide the other selections within that category. To unhide them, uncheck the box next to N/A.

13. The next section of the Review Outcome panel allows for the inclusion of a custom sub-form. In the example shown below, a sub-form is inserted that contains two sections (IRB Outcome and Test for Outcome Forms). Including a custom sub-form allows the institution to add any desired data fields not already included in the standard Outcome form (from which the Review Outcome panel is populated).

The custom sub-form is added by creating a new electronic data capture form and associating it to the applicable review board in the system Form Designer.

As demonstrated in the screenshot below, a new sub-form is added by clicking the Add New Form link under the Operations dropdown menu.

The form type to which the sub-form will be associated is selected. In this case this is the Review Board Outcome Form.

The user is prompted to associate the form to a specific board, ensuring the sub-form will appear in the correct Review Outcome panel per the applicable module.

Finally, the user can add the desired data capture fields to the sub-form.

Please see the Form Designer manual for full details of system form design functionality.

A table beneath the designated custom sub-form area contains submission history.

In the example shown above no prior versions exist, so the table is blank. Click the Add a Protocol Version amendment button to open the Protocol Version Tracking popup window, shown below.

The fields in this this window are described as follows:

• Reference Number is auto generated and read-only.
• Version Number defaults to a system-generated value, but the field is editable.
• To enter a Version Date, click the calendar widget, navigate to the desired date, and click that day to select it.
• Enter desired Sponsor Information and IRB Information in the provided text editor boxes.

Click the Cancel button to close the popup without saving changes. Click the Save Protocol Version button to close the popup and save the entered details to the protocol version amendment table on the Review Outcome panel.

14. The following sections will only appear in the Review Outcome panel if there are drugs and/or devices attached to the study that are pending approval.

Clicking on the View Details “+” icon will display details regarding the drugs or devices as entered in the drug or device data value within the study application.

15. The next sections of the Review Outcome panel provide read-only details of the submission’s status within each additional board to which it was submitted. In this example, the submission was sent to the IRB, Radiation Safety Review, and IBC Boards.

Once you have completed entering the Review Outcome information, click the Save the Selection button to save the change. The following popup window will appear asking if you want to update the current Study Profile. Selecting Yes will update the Study Summary Profile, selcting no will only update the Review Outcome panel. Make your selection and click Save Selection.

Once saved, the newly entered information will display as read-only on the Review Outcome panel as shown below. To make further changes to these outcome fields, click on the Edit Outcome Details button and repeat the process.

Configurable Validation Rules for Outcome Processing

The Submission Outcome tab in submission processing enables board coordinators to modify and finalize the status and review outcome of a submitted study.

Due to the large variability of data fields that may appear on this tab, implementing a universal set of validation rules for this page is not a prudent solution for most users. To address this issue, iRIS™ comes with a configurable Submission Outcome validation feature.

Configured validations are run in two locations: the Review Outcome panel, when the Save the Selection button is clicked, and the Review Complete panel, when the Complete the Submission Review button is clicked.

Setting up outcome validations in iRIS™ is done within a study board’s Review Board Administration section via the Setup Submission Outcome Validation link.

Clicking this link opens the Setup Review Board Outcome Validations page.

The page includes a display table showing all existing configurations and an Add Validation button at the top right of the screen. Clicking this button opens the Add Outcome Validation popup, shown below.

The upper portion of the window provides fields to name the validation, associate it to a specific field on a specific submission form, provide an error message to display to the user when the validation fails, and provide mouse over tool tip text for the field to which the validation applies.

Clicking the Validation Field Association button opens a secondary popup window, containing all data fields on the selected submission form. The data field chosen in this window will display the configured error message.

Clicking the Edit Error Message button opens a secondary popup window, containing a rich text editor for entry of the error message. This is the message that displays on the field that was selected via the Validation Field Association button.

In this example, the IRB Expiration Date data field was chosen as the associated field. The error message “Please enter an IRB Expiration Date, this cannot be blank!” is used. If this validation fails, the error message will display as shown below.

Optional tool tip text may be entered in the multi-line Tool Tip text box. This Tool Tip displays next to the selected validation field regardless if the validation is successful or not. As an example, consider the tool tip below, configured for the IRB Expiration Date validation mentioned above.

On the submission processing side, the IRB Expiration Date field will contain the tool tip as shown below.

Validation rules are entered in the lower section of the Edit Outcome Validation popup window. This is done using the system’s “rule builder” table, highlighted by the red box in the screenshot below.

See the Submission Outcome Validations guide for full details on outcome validation configurations in iRIS™.

Outcome Tab Validations

Configured validation rules run on the Review Outcome window when the Save the Selection button is clicked and when you attempt to complete the submission as shown below.

Note that more than one validation may be applicable to a given submission outcome and validation checks run in the order that the associated fields appear on the Review Outcome panel.

If a validation fails when the user attempts to complete the submission, the error popup shown below displays, informing the user that the submission cannot be completed until errors on the Review Outcome panel are fixed.

Once these errors in the Review Outcome panel are addressed and the outcome information is saved, the submission will be automatically completed.

Display Submission Components

The Display Submission Components panel on the Submission Outcome tab is a copy of the previous Display Submission Components panel discussed earlier in this document. Here the user can view, create, and approve components from the submission. Please see the Submission Components section earlier in this manual for more detailed operations.

Outcome Letter

The Outcome Letter panel is used to create an Outcome letter to be sent to the Principal Investigator and study team.

To create an Outcome Letter, click on the Create Outcome Letter button and the following popup window will display.

Select the applicable Notification Letter type from the dropdown list and click on the Save the Selection button.

This opens a Microsoft word-embedded page allowing the user to edit the merged letter template in Word Online or Check In/Out the letter, as shown below. Any template associated with the selected Notification Letter type is automatically imported to Word Online but can be revised as desired. Submission details (Reference Number, Submission Type, Study Number, and Assigned Analyst) are shown in the left-hand sidebar of the page.  

Please note that the user can edit the Header and Footer in Word Online as shown below.

To Check In or Check Out the letter, click on the Check In/Out Tab for the options as shown below.

Select “Yes” for Does this letter require signature signoffs? to indicate the letter will be routed for signoffs. A Share this letter with other Boards? question populates immediately beneath the signoff question. Select “Yes” to share the letter with other boards, select “No” to keep it private to the current board.

If “Yes” is selected for sharing the letter with other boards, a list is provided with select checkboxes for selection of the boards to be given access to the letter. Click to select each board that is to be given access.

If “Yes” is selected for sharing the letter with other boards, a list is provided with checkboxes for selection of the boards to be given access to the letter. Click to select each board that is to be given access.

Make changes to the content of the letter as desired.

Click the Maximize Word Editor button to expand Word Online to the full width of the window. Click the Minimize Word Window button to return to the normal view.

If templates are in use by the institution, click the Insert Template Language button to insert pre-formatted boilerplate text sections previously created for use by the board. Available templates are listed in the Insert Template Language popup, as shown below. Click to select the desired template and apply it to the letter.

Click the Save Letter Changes button to save the letter. It is added to the Outcome Letter section of the Outcome tab.

From here, the letter can be deleted, sent to the study team, or edited. Some table items in the screenshot shown above change with the status of the letter. Columns shown include:

Delete/Void — this column contains a Delete icon (left icon below) for letters that have not yet been sent and a Void icon (right icon below) for sent letters; click the icon to delete or void the letter; note that voided letters have the word “VOID” printed across them as a large watermark to ensure the letter cannot be resent as-is

Edit/View — click the icon in this column to open the letter for editing or review; note that if the letter is saved as a PDF, it may not be editable

Title — title and version number of the Outcome letter as displayed in the Submission Outcome tab and elsewhere in the system

Signature Required — displays “Yes” for letters requiring signoffs prior to routing, “No” for all other letters 

Status — displays “Waiting to be sent” for letters that are ready to send, “Waiting for be Routed for Signoff” for letters requiring signoffs prior to sending (a corresponding button populates in the Route Signoff column), “Routing in progress” for letters currently being routed for signoffs prior to sending, “Denied in routing” for letters where at least one signoff reviewer has entered a denial status, and “Routing complete ready to be sent” for letters where all required signoffs have been collected and the letter is ready to send

Route Signoff — a Manage the Routing List button appears in this column for letters requires signoffs prior to sending; click the icon to open the Letter Recipients page for selection and review of required signoffs; clicking the icon after signoffs are assigned opens a page displaying the required signoff names and their respective signoff statuses

Send — this column contains an active Send the Notification Letter button for letters that have not yet been sent, a disabled Send the Notification Letter icon for sent letters with pending signoffs, and a Re-send the Notification Letter button for sent letters without signoffs pending

When the Send the Notification Letter or Re-send the Notification Letter button is clicked, the Letter Recipients page (shown below) opens for selection of letter recipients. See the “Sending a Letter” section of this manual, immediately following this section, for more information.

Copy — click the Copy the Outcome Letter button in this column to copy letter content into a new letter record, as shown below; the copied content can be revised as needed

Routing for Signatures

After saving the letter, if you indicate signatures are required on the letter, you will be directed to the Submission Letter Signoff Routing List page. 

There are two ways to add a user to approve and signoff on the letter: 

Add Review Board Signoff – This allows you to choose from any board member.

Add Non-Review Board Signoff – This allows you to choose any user in the iRIS™ database, regardless of their access to the Review Board.

After selecting the users required to signoff, their records will appear as shown in the screen shot below.

The columns of the user display table in the window above are described as follows:

Order Number – Specifies who will receive the signoff task first.

Name – This is the name of the user (selected from the drop-down menu) who must sign the outcome letter.  

Signoff – This column is only useful for the current logged-in user. An icon will populate in this column for each personnel. If you are looking at this page and are selected as the signoff personnel, the icon next to your name will darken and you will be able to signoff the letter by selecting this icon.

Approved – This area will display the status of the letter after the user has approved or denied it.

Include Signature – If this field is set to “Yes”, the user’s electronic signature will be included in the letter.

Allow Change – If this is set to “Yes”, the user designated for sign off will be allowed to edit the letter.

Date Received – Date user receives the letter for signature.

Date Completed – Date the user applies electronic signature.

Comments – Any comments the user may have entered upon sign off.

Delete Selected Signoff(s) – Delete users selected for signoff by checking the box next to their name and clicking button.

Once all selections are made, click “Yes” in the field Have you completed your selection of required signatures? This will send the Outcome Letter Signoff tasks to the selected users when you save the signoff list.

Click the Save Signoff List button.

At this point, the system will send the signoff tasks and the outcome letter will be converted from a Word document to a PDF.

Click the Back button to navigate back to the Outcome Letter panel.

Any user assigned to sign off on an Outcome Letter will receive a homepage task.

Opening the Signoff task will open the letter in a new page. If the user signing the letter had been given rights to edit the letter, the letter on this page would display as an editable document within an embedded browser. The example below displays the PDF letter, meaning that this user was not granted the ability to modify the letter before approving or denying the letter.

To the left of the letter, study and submission information is listed. There is a drop-down list that the user can use to select either Approve or Deny.

Comments can also be added to the letter on this page.

Denying the Outcome Letter

At the point where the user selects the “Deny” option from the dropdown, they are given the option of revising the letter if the Allow Change dropdown was set to “Yes” from the routing signoff page of the letter. Revising a copy of the letter opens to a new Word Online page displaying an editable version of the sent Outcome letter. From here the user may add comments or revisions to the letter content.

If the user denies the letter and clicks on the Save button, the system will update the letter record in the Outcome Letter panel. The letter status updates to reflect the signature was denied and the letter cannot be sent.

Click the Manage the Routing List button.

Because the letter was denied, any other signoff tasks have been cancelled and the Submission Letter Signoff Routing List page is locked down. There will display a Word icon in the Approved column for the user that denied the letter if changes were suggested as shown below.

A new page will open. The modified letter is displayed in the embedded Word Online editor. You can view the changes made by the signee. Click the Copy Revised Letter to make additional changes.

A copy of the letter will need to be made, because the original letter has been denied and locked down for version control. Creating a copy will create a new Outcome Letter record that you can also route for signatures and send to the study. The screenshot below shows two Outcome Letter records: Version 5 and Version 6. Version 5 has been denied approval and is thus locked down. It cannot be sent, and it cannot be modified. You can, however, delete the Outcome Letter. Copying Version 5 creates Version 6 of the Outcome Letter in an editable state that can be routed for signoff or sent to the study personnel.

Approving the Outcome Letter

When the approval signoff is completed, the letter will generate a PDF. If the signoff task was flagged to “Include Signature” and the “Electronic Signature” merge code has been inserted into the Outcome Letter template, the signature information will populate in the Outcome Letter.

Returning to the Outcome Letter panel, the letter record will update indicating that signature routing is complete in the Status column.

At this point, the Send the Notification Letter button will be visible, allowing you to send the letter to the study personnel.

You can click on the Manage the Routing List button to obtain any additional details about the signoffs collected for the Outcome letter.

The Submission Letter Signoff Routing List page will be opened. Since the letter signoffs have been completed, this page will be locked down from editing. Comments added by any of the assigned users can be viewed in the Comments column.

Sending a Letter

When the Send or Resend button is clicked, the Letter Recipients page (shown below) opens for selection of letter recipients.

A new feature, the ability to create groups of Review Board members and filter by these groups when selecting members to send items, has been added to this version of iRIS™ to aid institutions with large numbers of members on their boards.

Study and submission information is listed at the top of the page (Submission Type, Study Number, Study Title and Reference Number).

Letter Title may pre-populate, but the field is editable.

The Key Personnel section lists Study/Project Personnel, sponsor contacts, and members of applicable review board committees. Select the checkbox next to a name to include that person in the list of Outcome Letter recipients.

Click the Add recipient from directory button.

The Search User Directory page opens for user lookup. Click the icon in the Select User column to add the corresponding user to distribution for the letter.

The user is added to the Additional Recipients table at the bottom of the page.

Click the Add recipient manually button on the Letter Additional Recipients page to add a recipient from outside the system.

The Letter Additional recipients page opens. Click the Add a Recipient button.

A blank row is added to the table for entry of the recipient’s Name and E-mail address (shown above). Repeat this process as needed to add all required recipients. Click the Save and Return button to save changes and close the page. The recipients are added to the Additional Recipients table (shown below) with the Send if checked box pre-selected.

Note that the Association field is a required field. Enter each recipient’s Association to the study/submission. Also note that Additional Recipients cannot be deleted once added. To prevent letter routing to Additional Recipients, de-select the checkbox next to the applicable recipient’s name.

Click the Send to selected recipients button at the top right of the Letter Recipients page (shown below) to send the letter.

Letter details are updated in the Outcome Letter panel as shown below.

Submission Complete

When review board submission processing is complete, whether for Pre-Review, Full Board Review, Designated Member Review, Expedited, Exempt, or Process Administratively, the last panel to complete is the Review Complete panel to mark the submission complete.

CAUTION: Do not complete this step until submission processing is complete. If the submission is set to return to the study for changes, the system generates a response form for return to the study. The submission is locked against editing, making changes to Outcome information, generating letters, assigning reviewers, or creating stipulations.

If the submission is marked complete in error, this status can be Unlocked in the General Information tab of the board submission processing area. However, if the submission was returned to the study for corrections, the outcome status cannot be reset until the study returns the submission to the board.

To complete the submission, click on the Complete the Submission Review button on the right-hand side of the Review Complete panel. The Review Outcome Validations will run again and if no errors are present, the submission will be locked and marked complete. The submission record will then move from its current tab to the Completed Submissions or the Pending Response tab in the submissions queue. The Pending Response tab is for submissions that have been completed but are waiting for corrections/responses from the study team.

The Review Complete panel of the tab also includes board decision details: Review Outcome and Additional Information Required.

Correspondence

The Submission Correspondence button will take the user to a new browser window that enables the management of all submission correspondence. Clicking this button will take the user to a new window, allowing them to both review the submission and compose correspondence simultaneously.

All existing correspondences for the submission are listed in the Submission Correspondence panel.

To add a new correspondence, click the Add a New Correspondence button. The Submission Correspondence popup opens for creation of the correspondence.

This page includes the following elements and controls:

Send E-mail — select this checkbox to specify that the correspondence is to be sent to indicated recipients; the correspondence is made available under My Assistant regardless of whether or not it is sent via email

Subject — email subject line

Recipient(s) — Click this link to open the Correspondence contact window (shown below), click to select the box(es) next to each applicable recipient name; click the header icon of the select column to select all of listed personnel; click the Save Changes button to save changes and close the Correspondence contact window and add the selected names to the Recipient(s) list

Additional Recipient(s) — click this link to open the Additional Contacts window (shown below)

The Additional Contacts window is used to include people outside the system in the correspondence distribution; click the Add A New Contact button on the page to open an add form for entry of the recipient’s name and email address (shown below).

Enter the Name and a valid E-mail Address for each recipient to be added. If a contact is added in error, select the checkbox next to the contact Name and click the Remove Selected Contacts button to delete it from the list. When all desired items are entered, click the Save Changes button to close the Additional Contacts window and add the entered names to the Additional Recipient(s) list.

Reply To(s)/ Additional Reply To(s) — click either of these links to add users who are to be copied on correspondence replies originating outside of the system; when someone outside the system replies to the correspondence thread, users listed here will receive an email notification

Attachments — click the Add Attachment button to open the Add Attachment window (shown below), where an attachment file Title can be entered and the attachment uploaded

Enter the desired Title and click the Upload button. An upload dialog popup opens, as shown below. 

Click the Choose File button, navigate to the desired file and click to select it. When the file is listed next to Document Location, click the Save selected file button to complete the upload. Back on the Add Attachment window, an icon for the attachment displays next to the Title. To replace this document with another, click the Upload button again and repeat the upload process as described.

If it is necessary to delete an attachment, select the checkbox next to the applicable Title and click the Delete Attachment(s) button. Multiple items can be selected and deleted simultaneously using this method.

Please note that the total size of all attachments is displayed here as well as the system-configured maximum size allowed.

Template — if using a preformatted correspondence template, click to select it from the dropdown list

Import Template — click to import the template selected in the Template field

Content —text editor for entry of correspondence content 

After all correspondence content and information is entered; click the Save & Send Correspondence button. The correspondence is now listed in the correspondence display table (shown below).

In the event you are not ready to send your message but want to retain your changes, click on the Save Draft Correspondence button to save your message as a draft and return later to save and send.

Add a reply to the correspondence thread by clicking the Post a Reply to this Topic link.

Click the Forward this Topic link to forward the message to a recipient using the recipient lookup tools described previously in this section.

Click the View Message icon for the applicable item to view a read-only copy.

Correspondence Attachment Size Validation

An attachment file size validation feature has been added to the Correspondence page. The page now displays the total size of attachment(s) and the total size allowed for an attachment(s) under the Attachments section.

The total size of the attachment is configurable under System Administration > System Configuration > System Default Settings. The total size allowed is specified in the system.max_file_size property.

If the size of the attachment(s) exceeds the size limit configured when uploading a file, a validation message of “ERROR UPLOADING FILE: File Size limited to ___ MB” displays.

Note: the MB limit displaying in the validation message will depend on the system configuration for the property (see image below).