Submission processing features are accessed via the IRB Assistant Workspace. Depending on the system configuration, submission processing may be accessed via a Submissions link and icon or Committee Submissions link and icon.

Review Board Limited Administrative Rights

A new rb.use_limited_admin_rights property has been created under Board Configuration > Board Setup.

When this property is set to “Yes” an option for limited administrator rights is made available when giving users administrative board level access.

Users assigned Limited Administrative Rights have access to the items shown below under Review Board Administration. Board members can be assigned access to view and edit notifications and letter templates when board level role access is set.

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.

A new property, rb.use_common_rule_display, has been added under IRB > System Configuration. The property defaults to “No”, and must be changed to “Yes” in order to enable the changes described in this section.

As shown in the screenshot above, a column indicating whether the study is under the 2019 Common Rule (Yes/No displayed depending on the drop down from the Outcome tab, shown below) has been added to the Find a Protocol page.

New studies being submitted should display “Yes” for the 2019 Common Rule column.

A new Common Rule filter has been added to the search box at the top of the Find a Study page. The drop down list includes options to display only “2019 Common Rule Studies”, only “1991 Common Rule Studies”, or “All”. The default setting for this field is “All”.

As shown in the screenshot below, the same changes have been applied to the Board Submissions page.

As shown in the screenshot below, the applicable rule now displays in the Study / Submission header.

An associated Merge Code (“Common Rule”) has also been added to the system for use in Meeting Minutes, Meeting Agendas and Outcome Letters. The Merge Code field populates with the applicable rule.

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 > Board Configuration Options > Submission Review Properties. The default value of this property is “ Yes”.

When the property is set to “Yes” and the submission goes to multiple boards, any new components attached to the submission by Board A automatically appear under submission components for Board B as well. This allows boards to always have latest components in 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 by which board.

Board Submissions Page

Click the Submissions or Committee Submissions link to open the Board Submissions page (shown below).

The page serves as a portal for all stages of submission processing. A search form is provided at the top of the page. A table beneath the search form organizes submission processing tasks into six categories.

The Not Assigned tab (shown in screenshot below) is selected by default. This tab lists submissions that have not yet been processed.

The Assigned tab (shown in screenshot below) lists submissions that have been processed and assigned for review. This tab includes the same columns as those shown in the screenshot above for the Not Assigned tab, and adds two more: Review Process and Assigned Reviewer.

The Completed tab (see screenshot below) provides links to previously processed and completed submission forms.

In addition to columns shown on the other tabs, the Completed tab includes columns for Letters, Department / Study Number, and Date Completed. Where an icon appears in the Letters column, hover over it to view letter details. Letters that have been sent are labeled as such in the detail text (see screenshot below).

The Agendas tab (shown in screenshot below) provides access for review and management of agendas for scheduled review board meetings. The page opens to details of the next upcoming review board meeting by default.

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

The Pending Action tab (shown in screenshot below) lists submissions awaiting a response, or with pending study side tasks.

The Outstanding Board Tasks tab (see screenshot below) contains a list of submissions that require action from the review board side. The task type and assignment indicate tasks to be completed and to whom each task was assigned.

Submission Processing

Submissions that have not yet been processed populate in the Not Assigned tab of the Board Submissions page (see the Board Submissions Page section of this manual, immediately preceding).

Where sort icons like those shown below appear in a column heading, the heading can be clicked to sort the submissions in ascending or descending order by that column.

The columns shown on this tab are as follows:

Display Submissions By – reference number (IACUC, IRB, etc.) to use as the column heading

or (Display Response) – a green icon indicates there is an attached submission correction that was made prior to the board meeting available for review; a red icon indicates there is an attached submission response (for submissions already reviewed) available

IRB Number – IRB Number assigned to the study, where applicable

Ref Number – unique, system-generated reference number for the form

Type – form type submitted to the review board

Date Board Received – date the submission was originally received by the board

IRB Expiration Date – IRB Expiration Date assigned to the study; note that newly created studies do not yet have an expiration date assigned, but continuing studies that submit items to the board do have a date assigned here

Full Renewal Expiration — IRB Full Renewal Expiration Date assigned to the study; note that newly created studies do not yet have an expiration date assigned, but continuing studies that submit items to the board do have a date assigned here

Principal Investigator – name of the Principal Investigator on the study

Assigned Analyst – name of the assigned Analyst, where applicable

Department — originating department, where applicable

Click the icon in the Open column to process the corresponding submission. The submission processing area opens, as shown below.

Note that tabs shown in the left-hand sidebar menu will vary depending on the specific system configuration and details of the individual submission. Additional tabs populate as processing of the submission proceeds.

The header on this page remains visible on all tabs, 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.)

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

Reference Number —submission reference number

Project/IRB Number — project number or IRB number

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 stages of processing

Expiration Date — study expiration date, where applicable

General Information

The topmost tab in the left-hand sidebar of submission processing screens is General Information. The page opens to this tab by default.

The General Information tab includes basic details about the study, study personnel, and Conflict Of Interest (COI) and training status for study personnel (if applicable).

If a user has multiple board access and the submission is sent to different review boards, the additional board(s) name(s) is/are listed at the top of the General Information tab. Each board name shown is linked to the corresponding board submission processing area.

In the example above, the user has access to both SRB and IRB boards and is viewing a submission that has been submitted to both of those boards. Clicking the IRB link in the Multiple Boards section will open this same submission in the IRB board’s submission processing area.

The General Information section in the right hand side of the screen displays top level details of the study. The Master Lay Summary or Study Abstract from the submitted study application is also made available here.

Click the Edit the Master Lay Summary or Edit the Study Abstract link to add a summary to the applicable document in a text editor.

Enter the desired summary text. Click the Apply button to save changes and close the popup window.

The Study Personnel section provides access to view study personnel Role, Name, Account Status and (where COI features are in use) COI Under Review status.

Click the user icon to the left of a Name to open that user’s contact information record.

Where the COI module is in use, 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 shown.

Submission Components

The Submission Components tab provides pre-review access to submission form(s) and any associated documentation. 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 what the study included with their submission form.

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 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 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 multiple times with no limit for pre-review changes or post-review corrections, meaning that a submission can have an unlimited number of rounds.

The study may revise or add consents or study documents 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 (see red box in screenshot below).

The first time the button is toggled to Items in List View; the display defaults to the current round (see screenshot below). A new Show submission component(s) in round field populates for selection of a round from the drop down list. The Compare option is not available in this view, as only documents for a single round are displayed in this view.

Components displayed in this view pertain only to that round’s documents. New versions and attachments for the round are included.

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 starting version number at the time of upload to the system and 0 denotes the incremented 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. Click the icon to expand a list of links to all available versions.

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 of an editable document or study consent item submitted as an attachment.

Click the icon next to the desired component; a pop-up prompts the user for confirmation of the version number. Click OK to proceed. When the revision is complete, the icon no longer appears in the Revise/Attach column because the 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. The attachment paper clip 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 for selection of the item version to be attached to the submission. Note that the example shown below is for IACUC board submissions, but the same screen is used for IRB submissions.

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

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.

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

When a consent form or other study document is opened, review board details about that document populate in a Consent Review / Consent Checklist panel, as shown below. The details shown on the panel are read-only at this stage because no changes can be made at the time of pre-review.

At the top left of the page is a table containing two columns: View the Unapproved Consent and View the Approved Consent (empty at this time, as there is no approved consent). Click on the icon of the document in the View the Unapproved Consent column to open the consent or other study document within the window.

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

Commenting on Submission Items

Comments can be added to any questions in the submission form and the first three sections of the application wherever the icon appears in the far right hand column, 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 highlight behind the comment icon, as shown below.

Modify or remove comments by clicking the icon again. Note that a time and 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(s) entered here visible to other reviewers. Leave the checkbox deselected to keep the comment(s) entered here private to the person who created them.

Commenting is also available for consents and other study documents when viewing the documents.

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 pop-up screen 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 section of the Submission Components tab of the Board Submissions page; click the plus sign icon in the More Details column for the applicable submission item to expand details.

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

Where applicable, other study documents include associated approval information.

A Compare Item(s) button is provided in the Display Submission Components section of the Submission Components tab of the Board Submissions page. This tool is only enabled where multiple versions of the same item exist for comparison.

Recall that where 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 currently in effect, either Items in List View or Items in Folder View.

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

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

Attach New Submission Component

Click the Add New Component button in the Display Submission Components section of the Submission Components tab of the Board Submissions page to add consent forms or other study documents to the active submission.

The Attach Protocol Document(s) popup opens, providing access to a list of study documents associated to the study. Any document previously attached to the submission is labeled Already Attached in the first column. Note that the screenshot below is from the IACUC board, but its content and format are the same when working with IRB submissions.

The Select an attachment type popup opens for selection of document type.

Select the applicable radio button. The Protocol Documents page opens for upload of the document and entry of its details.

Complete the form, upload the attachment, then click the Save Changes button to add the attachment to the Attach Protocol Document(s) list. The new document is added to the list and is automatically associated to the submission. An indication stating the item was added by the board is also displayed.

Click the X icon at the top right corner of the popup (shown in screenshot above) to close it. The newly added document is added to the list of other study documents in the Display Submission Components section of the Submission Components tab of the Board Submissions page.

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 “Already Attached” in the first column.

It is possible to choose any consent from the library, revise an existing consent, or add a new consent document.

When a new consent form is added the Consent Form History page opens for entry of consent information and optional form upload. Note that the Reference Number is automatically assigned.

After entering the information, click the Save Changes button to return to the list of consents on the study. The new record is added to the list, indicating the consent is attached to the submission. Note the indicator that the document was added by the board.

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 Consent Form History page. Click the Save Changes button to save the revision and close the Consent Form History page.

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

Click the X button in the upper right hand corner of the page to return to the Submission Components page.

Any consent document added displays in the table.

Create PDF Packet

Multiple submission components can be bundled and printed to PDF format.

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. Note that the screenshot shown below is for the IACUC board, but the same page is used in IRB submission processing.

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.

The Reorder PDF Packet popup (shown below) displays. Rearrange items shown in the list as desired by clicking to select 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.

When items are ordered as desired, click the Generate PDF Packet button.

The PDF is generated and opens in a new window. From the new window, the document can 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.

Click the Approve Attachments button to open 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 (shown below) 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) for each item.

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

When all approval information is entered click the Approve 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 page.

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

View in Separate Window

The View in Separate Window column of the Submission Components tab provides a tool to compare the last approved version of an application with the version currently attached to the submission while viewing the application in a separate window.

Click the icon in the View in Separate Window column to open the corresponding item in a separate window.

The selected item 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 for doing a side-by-side comparison between the last approved version of the item and 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 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 in the Details of Changes panel.

Correspondence

The Correspondence tab is where all submission correspondence is managed.

All existing correspondences for the submission are listed in the Submission Correspondence panel. In the example shown above, no correspondences have yet been created.

To add a new correspondence, click the Add a New Correspondence button. The Submission Correspondence page (shown below) opens for creation of the correspondence.

This page includes the following elements and controls:

Send E-mail — select this checkbox to specify 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 page (shown below); on the page, 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 page and add the selected names to the Recipient(s) list

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

The Correspondence Additional Contacts page is used to include people outside the system in distribution for a correspondence; 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 and Return button to close the Correspondence Additional Contacts page 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 receive an email notification

Attachments — click the Add Attachment button to open the Add Attachment page (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 page, an icon for the attachment displays next to the Title. To replace this document with another one, 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.

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 are entered; click the Save & Send Correspondence button. The correspondence is now listed on the listed in the Submission Correspondence panel of the Correspondence tab (shown below).

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).

Submission History

This tab displays the current workflow step for the submission and any previously completed steps.

The Task Status column (blue box and arrows in screenshot below) indicates the current status or board location of each processing step.

Any in-process steps are displayed at the top of the list. When a step moves from in process to completed, the step is automatically re-ordered by date/time stamp. Click the plus sign in the Task Status column (where available) to view full details of a task. In the example below, the “Pre-Submission” task is expanded.

The Task Name column contains the task name and where applicable, the name of assigned personnel

The Date Created and Date Completed columns contain those respective dates, as generated by the system.

The Total Time column is the cumulative total of time the submission spent in each step, as calculated by the system.

The Task Action / Details column contains available links/buttons for incomplete processing steps or for reviewing outputs from previously completed steps. In the screenshot below, the View Signoff Routing List button is clicked. Notice that its contents are read-only, as this step is complete. If the step were incomplete it would be possible to revise the submission routing and signoff list here.

In the screenshot below, the View Signoff button is clicked. Again, notice that the content is read-only because this step is complete. If the step were incomplete it would be possible to complete the signoff here.

Pre-Review Screening

This screen is used to assign the analyst, process the submission (i.e. pre-review changes assigned to agenda), and assign reviewers.

Note: Remember to click the Save the Pre-Review Screening button if any changes are made on this page.

This page includes the following elements and controls:

Assign Analyst – use the dropdown list to select the user who will provide and/or coordinate comprehensive technical and compliance pre-review of study submissions; with a user selected from the dropdown list, click the View Analyst Workload button to review that person’s availability

A panel opens to show the selected user’s current assignments.

Click the yellow folder icon to expand details of all assignments for the member. Click the Print button to print the list of assignments. Click the Close button to return to the Pre-Review Screening tab.

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

IRB Number – if the review board number is not automatically generated by the system, manually enter or generate a tracking number

Determine Review Process – select the applicable method for processing the submission form; additional processing tabs will populate and it will become possible to assign reviewers based on the process selected here

Review processes available are as follows:

Not Assigned - the submission defaults to this selection when first submitted; this selection indicates a review process has not yet been assigned and causes the form to populate in the Not Assigned tab

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

After selecting this option, up to nine additional tabs populate (depending on system configuration): Review Checklist and Comments, Review Summary, Submission Discussion, Stipulation, Internal Submission Routing, Vote, Outcome, Outcome Letter, and Submission Complete.

Expedite – if this item is selected the screen refreshes with the option of assigning a reviewer(s); click the Save the Pre-Review Screening button to save changes made to these fields

Designated Reviewer – if this item is selected the screen refreshes with the option of assigning the submission to a meeting date, and assigning the Designated Reviewer and Designated Member

Exempt - if this item is selected the screen refreshes with the option of assigning a reviewer(s) (see next section of this manual); click the Save the Pre-Review Screening button to save changes made to these fields

Pre-Review changes requested – this selection sends the submission back to the study for pre-review corrections; this selection populates the additional tabs listed previously in this section and also allows for assignment of reviewers (see next section of this manual)

Process Administratively – this selection indicates the submission is to be processed through the board but not subjected to full board review; this selection populates the additional tabs listed previously in this section and also allows for assignment of reviewers (see next section of this manual)

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

This tab is available on submissions that have been assigned a review process and allows for non-board member users (Add Reviewer button in screenshot below, orange box), board member users (Add Member button in screenshot below, blue box), or both to be assigned as reviewer for a submission.

Notice that the only difference between the two reviewer tables in the screenshot above is that the top table, for non-board members, includes a Specialty field. Apart from this field, the data captured for reviewers is the same in each table and the process of adding reviewers is the same for each table. The process is detailed below for a non-board member reviewer.

Click the Add Reviewer button (Add Member button for a board member).

The screen refreshes with a new row.

Click in the Reviewer Role field to open a dropdown list and click the desired role to select it.

If any role other than an Ad Hoc role is selected, the screen refreshes and populates the Specialty field. Note that Specialty is a configurable list under Review Board Administration. Click in the field to open the pre-configured dropdown list and click the desired Specialty to select it.

When a Specialty is selected, the dropdown Reviewer pick list is limited to those who have that specialty listed in their profile.

If an “Ad Hoc” role is selected (shown below), the screen refreshes with fields for selection of a Known System Identified User from a list or entry of the reviewer’s First Name and Last Name.

After selecting and/or entering the correct data, click the Save Pre-Review Screening button.

The screen refreshes with the assigned reviewer’s information saved as read-only.

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 OK button to proceed or the Cancel button to cancel the process.

Assigned reviewers receive a notification advising them 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 does not receive a notification until the Coordinator enables reviewer notifications for the applicable meeting date.

Comments to Reviewers

It is possible to enter comments that will be visible to all reviewers when assigning reviewers to a submission.

When the Add Review button is clicked and the first reviewer assignment record is created, an Add Comments for All Reviewers button populates at the top of the reviewer table (shown in screenshot below).

Click the button to open the Add Comments for All Reviewers popup (shown below). Enter desired comments, then click the Apply button to save the comments and close the popup. Click Cancel to close the popup without saving comments.

When comments are added for the reviewer, button text changes to View Comments for All Reviewers. Click this button to view or modify the comments.

Reviewers Workload

It is possible to check the workload of a board member before assigning that member to review a submission.

Click the View Reviewers Workload button to open a table displaying applicable board member assignments.

Click the yellow folder icon to expand details of all assignments for the member. Click the Print button to print the list of assignments. Click the Close button to close the assignments table.

Submission Received Notification Letter

When the board receives a submission, an acknowledgement of receipt letter is created and sent to applicable study personnel. This feature is accessible via the Submission Received Notification Letter tab of the submission processing area.

Note that screenshots included in this manual section are taken from the IACUC module, but the same pages and features are applicable to other review boards.

Select the desired, pre-formatted Submission Received Letter type from the dropdown list and click the Create Letter button at the far right of the page.

A page with an embedded text editor opens for creation of the letter. Submission information is provided in the left-hand sidebar of the page (Reference Number, Submission Type, Study Number, and Assigned Analyst).

Select “Yes” for Does this letter require signature signoffs? in the left-hand sidebar to require signature signoffs for this letter. Another field, Is batch signoff applicable?, populates as shown below.

Batch signoff allows the assigned user(s) to sign off on more than one letter at a time. Select “Yes” to enable batch signoff for the user(s).

Select “Yes” for Share this letter with other Boards to expand a list of review boards configured in your system. Click to select the additional boards to be included in the distribution list for the letter.

While working on the letter, it is possible to expand the embedded editor to full screen width by clicking the Expand Word Window button. Click the Minimize Word Window button to return to the normal view.

When the letter is complete click the Save Letter Changes button.

The text editor popup closes and the record is added on the Submission Received Notification Letter tab.

The letter can now be deleted, sent to the study, or edited. Columns shown in the Submission Received Notification Letter list table change according to the status of the letter. Available columns are:

Delete — click this icon to delete the corresponding letter, provided it has not yet been sent (see next section of this manual)

Send — this button only populates for letters that have no pending tasks or signoffs; click Send to send the corresponding letter

Resend — after a letter is sent the Send button toggles to Resend; click the Resend button to resend the corresponding letter

Edit/View — click the icon in this column to open the corresponding letter for review or revision; note that if the letter is provided in PDF format it may not be editable

Title — title and version number of the letter

Signature Required — displays either “Yes” or “No” to indicate whether or not this letter requires signatures before it can be sent

Status — letter status; available statuses are:

‘Waiting to be sent’: the letter can be sent

‘Waiting to be Routed for Signoff’: signatures must be collected before the letter can be sent; in this case an icon populates in the Route Signoff column

‘Routing in progress’: the letter has been routed for signoff and cannot be sent until the requested signatures have been collected

‘Denied in Routing’: at least one required signatory denied the letter; the letter cannot be sent, and must be rerouted for signatures

‘Routing Complete Waiting to be sent’: required signature(s) was/were collected and the letter can be sent

Route Signoff — if a signature is required on the letter before it can be sent this column is populated with an icon; clicking the icon opens a page for signoff assignment and review of signature status

Copy — click this icon to copy the corresponding letter content into a new letter record, which can be edited, saved and routed for signatures

Sending a Letter

Click the button in the Send column to open the Letter Recipients page (shown below).

The following study and submission specific information is listed at the top of the page: Submission Type, Study Number, Study Title, and Reference Number.

Enter the desired Letter Title. If the field has defaulted to a previous entry, it can be edited if desired.

Select letter recipients from those listed by clicking the applicable checkbox(es) to the left of the name(s).

Click Add recipient from directory to add a system user to the distribution list for the letter.

The Search User Directory page opens for user lookup.

To add a single user to distribution, when the desired user record is shown in the result set, click the icon in the Select User column. The search page closes and the selected user is added to the applicable Contacts table.

To add multiple users to distribution, click to select the corresponding checkboxes in the Check for Multiple column, then click the Save Selected User(s) button. The search page closes and the selected users are added to the applicable Contacts table.

The names of letter recipients from outside the system populate in the Additional Recipients table with their checkboxes pre-selected. Click to de-select any recipient who should not be included in distribution for the letter.

To add a new recipient from outside the system, click the Add a Recipient button.

A new row is populated in the table. Click the button again as many times as need to add rows.

Enter the Name and a valid E-mail Address for each recipient to be added. If a recipient is added in error, select the checkbox next to the Name and click the Remove Selected Recipients button to delete it from the list.

When all desired recipients are entered, click the Save and Return button to close the Letter Additional recipients page and add the entered names to the Additional Recipient(s) list.

Click the Send to selected recipients’ button on the top right of the Submission Received Notification Letter tab. The system generates a PDF from the Word document and attaches that PDF to the Submission Received Notification Letter.

Routing for Signatures

After a letter requiring signatures is saved, the Submission Letter Signoff Routing List page opens for entry of signoff assignments.

Two types of board signoff can be assigned.

Click the Add Review Board Signoff button to assign a board member for signoff.

Click the Add Non-Review Board Signoff button to assign any user in the system for signoff, regardless of their access to the review board.

The records of users assigned for signoff appear as shown in the screenshot below.

The columns in this table are as follows:

Order Number — order of routing for the signoff task, beginning with zero (0); users with the same order number in this column receive tasks at the same time

Name — name of the user (selected from the dropdown list) who assigned for signoff

Signoff — if the logged-in user is assigned for signoff, the icon in the Signoff column is enabled; click the icon to signoff

Approved —status of the letter (after the user has approved or denied it)

Include Signature — if set to “Yes,” the user’s electronic signature is included in the letter

Allow Change — if set to “Yes,” the user designated for signoff is allowed to edit the letter

Date Received —date the user received the letter for signature

Date Completed — date the user applied their electronic signature

Comments —comments entered by the user with signoff

To remove a user name added for signoff in error, select the corresponding checkbox in the far-left column of the table and click the Delete Selected Signoff(s) button.

After all selections are made, select “Yes” for the Have you completed your selection of required signatures? field (section highlighted green in screenshot below).

Signoff tasks are sent to users assigned for signoff. Click the Save Signoff List button (upper right in screenshot above).

The submission received letter is saved to the system as a PDF.

Review Checklist and Comments

This tab includes three sections: Reviewer Check List, Member Check List and Member Comments (shown in screenshot below).

Reviewers assigned in the Pre-review Screening tab are listed on this page, together with review status details. The first section lists reviewers who are not board members. The center section lists members who are board members. The bottom section for capture of board member reviewer comments desired.

Reviewer Check List

The Reviewer Check List table displays signoff tasks and details of their status.

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.

Other columns in the table are:

Reviewer Role — reviewer role

Reviewer — 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 where review Completed? status is “Yes”

Share Review with Other Review Boards — click the icon in this column to share the review with other review boards

Clicking the icon opens the panel shown below, where available review boards are listed.

Click the applicable checkboxes to select review board(s) in the list, and then click the Save the Selections button (button not shown in screenshot above).

When the review is shared with other boards, the Share Review with Other Review Boards column updates with a green background as shown below.

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 (shown in screenshot above, buttons are located immediately above the Reviewer Check List section of the Review Checklist and Comments tab) to open the Reviewer Checklist form.

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 can add comments for discussion at the board meeting to the submission.

Click the Add Member Comments button (shown in screenshot above, buttons are located immediately above the Reviewer Check List section of the Review Checklist and Comments tab) to open the Member Comments page.

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 with comments made visible to all board members. If this checkbox is unselected, the comments are posted anonymously.

Click the Save the comments button to save the comments and return to the Reviewer Checklist and Comments tab.

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

Review Summary

The Review Summary page contains a summary of any comments added to any of the submission components and a summarized view of any reviewer checklists that have been completed.

Comments from submission components and associated reviewer checklists can be merged into the Submission Discussion, an Outcome Letter, or a Stipulation.

Answers supplied in the Reviewer Checklist and comments added to submission components are summarized here, with three checkboxes next to each question. The options provided in each column are:

— select this checkbox to specify items to be merged into the Submission Discussion, the next tab in submission processing; typically, any item that should be flagged for review at the meeting is merged into the Submission Discussion; click the Merge Comments into Submission Discussion button to apply this merge

— select this checkbox 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 this checkbox 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); click the Merge Comments into Stipulations button to apply this merge

Click the Save the Checklist Status button to save changes.

Submission Discussion

The Submission Discussion tab is used to capture information related to the submission, such as notes from the analyst or any discussion about the submission that takes place during a meeting. Items from the Reviewer Checklist can be merged into the Submission Discussion tab. Submission Discussion tab content can be merged into letters and meeting minutes.

A text editor is provided for making additions or revisions to the discussion. Click the Save Submission Discussion button to save changes.

Recommendation

The Recommendation tab is where board member recommendations for the submission are maintained.

Use the provided text editor to enter and edit recommendations. Click the Save button to save changes.

Recommendations from this tab can be merged into letters and meeting minutes.

Stipulation

The Stipulation tab is where stipulations for the submission are managed.

The first time the tab is opened for a given submission; only stipulations merged from the Review Checklist and Comments tab are shown. In the example below nothing was merged so no stipulations are listed.

Add a New Stipulation

To add a new stipulation, click the Add New button (shown in screenshot above).

The Review Stipulation page opens for entry of stipulation details.

There are three process steps when adding a stipulation:

— select Stipulation Type

— associate components to the stipulation (optional)

— enter stipulation content

Click in the Stipulation Type field to open it and click an item in the dropdown list to select it. There are three items in the list:

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 — assigned to stipulations that require a separate follow up due date

Any stipulation or recommendation from the board that can be addressed separately from the submission approval criteria would be given this type. When you select “Comments that must be addressed” from the drop down list, a date field will populate, allowing you to specify what the stipulation follow-up due date is.

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

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

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

Enter desired Stipulation Content and click the Save the Stipulation button to save changes.

Associating Components

After selecting a Stipulation Type, it is possible to associate the stipulation with a specific submission component. Associating a component to a stipulation attaches the stipulation to that item such that when the study accesses the stipulations the system directs them to the associated submission component.

To associate components, 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 for creation of the association.

Three buttons are available:

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, which lists all existing associated components

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

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

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 and 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.

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 and 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.

When component associations are complete, click Done. The popup closes and the Review Stipulation page is updated with associated component request details. Click the Save the Stipulation button at the upper right.

Entered stipulations are now listed on the Stipulation tab of the submission processing screens. As shown below, any stipulation linked to a component in the submission is color-coded.

The following columns are included in the table:

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

Edit — click the icon in this column to open the stipulation for editing (editable fields are Stipulation Type, Associated Components, Stipulation Content)

Sorting Number — stipulation priority order

Stipulation Type — type selected for the stipulation

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

Stipulation — stipulation content

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

Link to Component – linking indicator for associated components; includes text reading “Click to link” if no component is yet linked, is color-coded if a linked component exists; click the icon to link a component or view the linked component, respectively

Add Multiple Stipulations

Click the Add Multiple button to add stipulations to a submission in a group.

This tool is used to paste in a pre-existing list of stipulations copied from an outside source, such as a Word document. Copy and paste the source list in the provided form, select the Stipulation Type, and save changes to add all the stipulations at once.

Each stipulation added is created as a separate record.

Add Pre-Defined

Click the Add Pre-defined button to add one or more predefined, or “canned”, stipulations. A panel 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 Selected Stipulations for Study button.

The pre-defined stipulations are added to the submission, and each is created as a separate record.

Merge From Review Summary

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

Comments made within a submission component are listed in the Reference column. The example above shows two comments made in the Study Application form. When these comments are merged into stipulations, the link to the Study Application is merged as well.

To merge any comment shown here into a Stipulation, select the corresponding checkbox in the flagging column, immediately to the left of the Name column. Click the Merge Comments into Stipulations button to complete the merge.

The selected stipulation(s) is/are added to the submission, and each is created as a separate record.

Stipulation Responses

When the submission is returned to the study 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 responses to stipulations populate in the Stipulations with the responses from the previous submission section of the Stipulation tab. Stipulation responses can be reviewed and then either closed/accepted or rejected. If a stipulation is rejected it can be copied into a new stipulation to be routed back to the study.

Click the icon in the Edit column to open the Process Stipulation page. Choose a Review Action and provide a date that the stipulation was closed in the Date Closed field. The date is only required if the stipulation is closed.

Click the Add Memo button to open the Stipulation Memo page. Enter desired memo text and click the Save button to save changes 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 submission processing screens.

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

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

It is possible to set the Review Outcome 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 Outcome 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 the 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 with the changes made.

Internal Routing

The Internal Submission Routing tab is used by review board Analysts to route the submission internally, any number of times, to all intended recipients simultaneously. Internal routing can be used to share a submission with a Chairperson or specialty reviewer.

The Internal Review Routing panel contains a table where internal routing history is tracked. From here, it is possible to create a routing list for the submission, create a note to accompany the submission, and send it.

Click the Assignment notes link (immediately above the highlighted completion block in the above screenshot) to create a routing assignment.

Click the Add Review Board Routing button to add a new routing assignment row to the table. Select a member from the dropdown list (shown below).

To add a user who is not a board member, click the Add Non-Review Board Routing button. The Search User Directory page opens for system user lookup.

Users added to the routing are listed in the order added, as indicated by the numbers in the Order Number column, beginning with zero (0). To re-order the users, change the numbers in this column. If two or more users in the list are given the same Order Number those users will receive the routing at the same time.

To add a reviewer-specific, reviewer-private assignment note to an individual user, click the Assignment Comments button above that user’s name. A text editor opens for entry of comments. Copy and paste text into the box or enter it manually, then click the OK button to save the comment.

The comments populate to the right of the Assignment Comments link when the applicable user opens their review task, as shown below. These comments will not be visible to any other users in the distribution list.

Repeat the process as described to add as many users as are needed to the routing distribution list. When all users are added and all comments are entered, click to select “Yes” for the Have you completed your selection of required routings? field (see highlighted block in the screenshot below) and click the Save Routing List button at the upper right of the Internal Review Routing panel.

The submission is now routed with associated notes to each assigned reviewer in the distribution list in order, beginning with the Order Number zero (0). As each user receives and completes the routing task, the next user in the distribution list is notified of the task until all reviews are complete. Users assigned the same Order Number are notified at the same time. If a user who has already been notified is deleted, routing continues with the next user, in ascending order.

As shown below, the tab updates with user routing assignment completion details and their comments as the submission is routed. Additional users can be added to the routing, if needed.

Vote / Expedited By / Acknowledged By

The assigned review process dictates the next tab to populate in the Submissions area sidebar menu.

When viewing a submission assigned for a full board review the Vote tab appears. The Expedited By tab appears when viewing a submission assigned for Expedited review. When viewing a submission assigned as Exempt the Acknowledged By tab appears.

Vote

The Vote tab allows you to capture the meeting vote for a full board review submission.

You can capture the vote at the time of the meeting, or any time afterwards but before you complete the submission processing. Start by clicking the Add Motion button.

The vote can be captured at the meeting, or any time between the meeting and completion of submission processing.

Click the Add Motion button to open the Submission Motion page.

Manually enter or copy and paste desired motion text into the text editor. Select a template from the Pre-canned Motion text dropdown list to use a pre-formatted motion template; then click the Add Canned Language button.

Click the Save Changes button to save the motion and close the page.

A motion is added in the Meeting Vote panel of the Vote tab, and voting member names are listed.

Note that voting members are not listed in the Meeting Vote panel until meeting attendance is set. Any voting member marked as present at the meeting is listed here.

Select the vote type in the Vote column to the left of each Member Name. Each member’s Gender, Specialty, Relationship to the Institution, Affiliation, Representational Capacity, and Representative of Specific Entity information is also shown, under the corresponding columns.

After votes for the motions are set, click the Save the Members Vote button. The vote is saved and can be used to merge into the outcome letters and meeting minutes templates (see the IACUC Review Board Administration manual).

Anonymous Voting

If anonymous voting is set up for the institution the Meeting Vote panel appears as shown below.

Enter the number of members who voted according to each Vote Type in the corresponding Number field. Add any comments, if desired. Click the Save the Vote Summary button to save the votes.

Expedited By

If the submission is set for expedited review, the next Submissions tab displays as Expedited By. Expedited reviewers can be assigned here in addition to any who were previously assigned in the Pre-review Screening tab.

The Expedited By panel contains a table of review board members. Click to select the checkbox in the Expedited column to indicate a board member’s approval or acknowledgement of the submission.

Click the Save the Acknowledgement button to save changes.

Acknowledged By

If the submission is set for exempt processing the next Submissions tab displays as Acknowledged By.

The Acknowledged By panel contains a table of review board members. Click to select the checkbox in the Acknowledged column to indicate a board member’s approval or acknowledgement of the submission.

Click the Save the Acknowledgement button to save changes.

Outcome

The Outcome tab is where submission outcome is set.

Note that screen elements shown on this tab may vary by institution.

If a submission is assigned a status of “Pre-review changes requested”, the Outcome tab only contains a Study / Protocol Status field for updating overall study status, as shown in the IACUC example below (other boards’ Outcome tabs work the same way). The review board may change the status to a selection indicating the study is in revision. Click the Save the Submission Outcome button to save any status change.

For submissions assigned a review processes, the Outcome tab is where outcome information for the submission is entered into the system.

Note that sections of the Outcome tab are shown in isolation in this manual section because the tab’s content is roughly ten scrolls long.

Notice that where a submission has an association to multiple boards, an alert section displays at the top of the page (see screenshot above) and lists all applicable boards.

Select the applicable Review Outcome from the dropdown list.

If the submission cannot be reviewed on its assigned meeting date, select a Review Outcome of “Tabled”, then and assign the submission to a different meeting for review. Leave Submission Approval and Study Status as is.

If an Outcome that will return the submission to the study is selected in the Review Outcome dropdown list (e.g., returned for stipulations), the column for Additional information required toggles from “No” to “Yes”, as shown in the screenshot below.

“Yes” indicates the submission is to be returned to the study for stipulations from the review board. In that case, the Submission Approval date field toggles 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 (shown below), leave the Submission Approval field empty and change the Study Status to a denied status type.

If an approval Outcome is selected in the Review Outcome dropdown list (shown below) and the Additional Information required field displays “No”, when the submission is marked complete here it moves completely out of the workflow.

Completing an Approval Outcome

Enter the applicable Submission Approval date (see screenshot below) by clicking the calendar widget and navigating to the desired date.

Enter the applicable Meeting Approval Date by clicking the calendar widget and navigating to the desired date.

Select the applicable Study Status.

For submissions assigned a review type of “Expedited”, “Exempt”, or “Administratively Processed”, fields are provided to Assign the Submission to Agenda. Complete that section as follows:

Committee Name – select the applicable committee from the dropdown list

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 from that list

Agenda Category – select the applicable category from the dropdown list

As shown below, three types of comments can be entered beneath Outcome details:

Internal Comments — comments visible only to members of the review board to which the submission is assigned

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

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

Complete the next section as follows.

IRB of Record defaults to “Yes”, indicating that the board processing the submission is the IRB of Record; this is the default setting for initial Reviews that submitted to the IRB; select “No” to indicate the IRB is processing the submission on behalf of another board; the system excludes those 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 in the Please Select the Type of Review Notification that Must be Sent field to open the dropdown list, then click the desired item to select it.

The next group of data fields in the Outcome tab is shown in the screenshot below.

Complete these data fields as follows.

IRB Initial Approval – click the calendar widget and navigate to the date the IRB initial approval was/is granted, then click to select that day; the initial approval date is entered here when processing an initial review and once entered, the field becomes read-only

Review Cycle – click in the field to open a dropdown list, then click the desired review cycle item to select it; review cycle used to update the IRB Expiration date based on the Submission Approval date

IRB Expiration Date – Outcome expiration date, can be manually entered or calculated by the system via a the Calculate Expiration Date button; with a Submission Approval date entered and an option selected in the Review Cycle drop down list, click the Calculate Expiration Date button to auto-calculate; the calculated date is based on the selected Review Cycle, minus one day

Note: when processing a submission that is not in Initial Review or Continuing Review status, 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 – click in the field to open a dropdown list, then click the desired number of days item to select it

Continuing Review Due – click the calendar widget and navigate to the date a continuing review is due, then click to select that day

Study Follow-up – click the calendar widget and navigate to the date a study follow-up is due, then click to select that day

The following fields are used only where applicable to the study:

Temporary Closed — set this flag to “Yes” to temporarily close the study; note that this change causes the Temporary Closure Start and Temporary Closure End fields to populate

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

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

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

The next section of the Outcome tab is shown below.

Risk Assigned — click in this field to open the pre-configured dropdown list of general risk profiles, and click to select the applicable item

Adult Risk Assigned — click in this field to open the institution-defined dropdown list of adult-specific risk profiles, and click to select the applicable item

Adult Benefit Assigned — click in this field to open the institution-defined dropdown list of adult-specific benefit profiles, and click to select the applicable item

Pediatric Risk Assigned — click in this field to open the institution-defined dropdown list of pediatric-specific risk profiles, and click to select the applicable item

The next group of data fields in the Outcome tab is shown below.

Non-Human Subject Research (NHSR) — select “Yes” to indicate 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; where Subject Management is in use, the number of approved subjects in this field controls the number of subjects the study can enroll

Subject Justification — enter the text of the subject justification statement

Controls Approved — number of allowable controls approved for the submission

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

The next section of the Outcome tab is shown 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

The next section of the Outcome tab includes fields to specify Risk Level and to Select Categories for Study. Click to select the desired checkbox(es) and picklist items.

The following sections of the Outcome tab cover optional categorizations that can be applied to the submission by clicking to select the desired checkbox(es). Note that the sections, items and item text shown in these sections can be configured by the institution when the outcome form is configured in the Forms 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.

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

The custom subform is added by creating a new electronic data capture form and associating it to the applicable review board in the Forms Designer.

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

The form type to which the subform will be associated is selected; in this case, the Review Board Outcome Form.

The user is prompted to associate the form to a specific board, ensuring the subform will appear in the correct Outcome tab per the applicable module.

Finally, the user can add the desired data capture fields to the subform.

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

A table beneath the designated custom subform 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.

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 entered details to the protocol version amendment table on the Outcome tab.

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

Click the Save the Submission Outcome button (red arrow and box in screenshot below) to save all changes and the selected Outcome. Any changes made to the study are applied immediately, but the submission is not returned to the study until Submission Complete tab processing is finished.

Configurable Validation Rules for Outcome Processing

The Outcome tab in IRB 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, a configurable Submission Outcome validation feature was introduced for IRB Assistant in the 12.01 release of iRIS™.

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

The setup for the Outcome validations is done within the IRB Assistant Review Board Administration section via the Setup Submission Outcome Validation link.

Clicking that 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 the button opens the Add Outcome Validation popup, shown below.

The upper part of the popup provides fields to name the validation, associate it to a specific field on a specific submission form, provide an error message for display to the user when the field’s content fails to pass the validation, 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.

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 when the validation fails.

In this example, the Study Follow-up data field was chosen as the associated field. The error message “Please enter a Follow-up Date” 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 Follow-up Date validation mentioned above.

On the submission processing side, the Study Follow-up date field will contain the tool tip as shown below.

Validation rules are entered in the lower part of the Add Outcome Validation popup, to assign logic to the validation. This is done using the system’s “rule builder” table, highlighted by the red box in the screenshot below.

See the IRB Assistant – Submission Outcome Validations manual for full details of outcome validation configuration.

Outcome Tab Validations

Configured validation rules run in the Outcome tab when the Save the Submission Outcome button is clicked (see below).

Note that more than one validation may be applicable to a given submission outcome and validation checks run in the order the associated fields appear on the Outcome tab. If a validation fails when the user attempts to save the outcome the error popup shown below displays, displaying the error message configured during submission outcome validation setup.

Graphical user interface, text, application

Description automatically generated

When the user clicks the Go to the Outcome Tab button in the popup, the popup closes and the field that caused the validation error to fire is highlighted with error text on the page, as shown below.

Recall that each validation configured is run in order when the Save Outcome button is clicked. The outcome cannot be successfully saved until all validation checks are run and pass for the submission.

Submission Complete Tab Validations

Validations run in the Submission Complete tab when the Save the Submission Complete button is clicked (see below).

If a validation fails when the user attempts to save the outcome the error popup shown below displays, displaying the error message configured during submission outcome validation setup.

Graphical user interface, text, application

Description automatically generated

When the user clicks the Go to the Outcome Tab button in the popup, the popup closes, the user is returned to the Outcome tab and the field that caused the validation error to fire is highlighted with error text on the page, as shown in the example below.

The system retains the checkbox in the Submission Processing Complete field on the Submission Complete tab (first screenshot below), so that once any validation error(s) is/are corrected the submission is marked complete and locked against further changes immediately after the Save the Submission Outcome button on the Outcome tab (second screenshot below) is clicked.

It is not necessary for the user to return to the Submission Complete tab to mark the submission complete and save it again, the system completes those steps automatically.

Outcome Letter

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

Select the applicable Notification Letter type from the dropdown list. A Create Letter button populates (button is not shown in screenshot below).

Click the Create Letter button.

The Letter page opens for creation of the letter, as shown below. Any template associated with the selection Notification Letter type is automatically imported to the text editor, 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.

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.

Make changes to the content of the letter as desired.

Click the Expand Word Window button to expand the text editor to the full width of the window. Click the Minimize Word Window button to return to the normal view.

Where 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, 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

Send — this column contains an active Send icon (left icon below) for letters that have not yet been sent, a disabled Send icon (right icon below) for sent letters with pending signoffs, and a Resend icon (center icon below) for sent letters without signoffs pending (see

When the Send or Resend 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.

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

Title — title and version number of the Outcome letter as displayed in the 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 icon 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 — an icon 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 the page displays required signoff names and their respective signoff statuses

Copy — click the icon 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 Saabertech 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.

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 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 convert from a Word document to a PDF.

Click the Back button to navigate back to the Letter page. The Outcome Letter now appears in the window as an un-editable PDF document.

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 above displays the PDF letter, meaning 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 denies and saves the letter, the system will update the letter record in the Outcome tab, in the Submission Processing screens. The Status updates to reflect the signature was denied and the letter cannot be sent.

Click the Route Signoff 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. You can click on this to view any suggested changes.

A new page will open. The modified letter is displayed in the embedded Word editor. You can view the changes and make any other necessary modifications. Once necessary changes are made, click the Copy Revised Letter.

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 signature and send to the study. The screenshot bellow shows two Outcome Letter records, Version 1 and Version 2. Version 1 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. Version 2 of the Outcome Letter is in an editable state and can be routed for signoff or it can be 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, similar to the screenshot above.

Returning to the Outcome tab in the Submission Processing screens, the letter record will update indicating that signature routing is complete in the Status column.

At this point, the Send icon will be selectable, allowing you to send the letter to the study personnel.

You can click on the icon in the Route Signoff column 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. And 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.

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.

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 tab.

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 submission moves to the Submission Complete tab.

The submission remains in an Assigned status (and is listed on the Assigned tab in the Submissions queue) until the Submission processing complete checkbox (shown in screenshot above) is selected and the Save Submission Complete button is clicked on the Submission Complete tab.

Until those steps are taken, the submission approval process is not complete.

CAUTION: Do not complete these steps 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 reset in the General Information tab of the board submission processing area. However, if the submission was returned to the study for corrections, outcome status cannot be reset until the study returns the submission to the board.

Select the Submission processing complete checkbox and click the Save Submission Complete button in the Review Complete panel of the tab to complete submission processing. The submission record moves from the Assigned tab to the Completed tab in the submissions queue.

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

The Review Outcome Letters panel of the tab lists outcome letters generated for the submission. Letters that have not yet been sent can be opened for revision by clicking the icon for the applicable letter in the Edit/View column. Letters previously sent can be viewed by clicking the same icon, but are locked against revision.

The last panel on the tab is Display Submission components status, which lists all submission components and their current status.

See the Submission Components section of this manual for details of working with submission components. The functionality of the Submission Components tab extends to this panel of the Submission Complete tab.

Review Board Limited Administrative Rights

Common Rule Display

Documents Sync Across Boards for Parallel Submissions by Default

Board Submissions Page

Submission Processing

General Information

Submission Components

Folder View vs. List View

Document Versions

Viewing Submission Items

Commenting on Submission Items

Viewing Additional Submission Item Details

Attach New Submission Component

Consents

Other Study Documents

Create PDF Packet

Approve Attachment(s)

View in Separate Window

Compare to Last Approved

Correspondence

Correspondence Attachment Size Validation

Submission History

Pre-Review Screening

Assign Reviewers

Comments to Reviewers

Reviewers Workload

Submission Received Notification Letter

Sending a Letter

Routing for Signatures

Review Checklist and Comments

Reviewer Check List

Member Check List

Member Comments

Review Summary

Submission Discussion

Recommendation

Stipulation

Add a New Stipulation

Associating Components

Add Multiple Stipulations

Add Pre-Defined

Merge From Review Summary

Stipulation Responses

Internal Routing

Vote / Expedited By / Acknowledged By

Vote

Anonymous Voting

Expedited By

Acknowledged By

Outcome

Completing an Approval Outcome

Configurable Validation Rules for Outcome Processing

Outcome Tab Validations

Submission Complete Tab Validations

Outcome Letter

Routing for Signatures

Denying the Outcome Letter

Approving the Outcome Letter

Sending a Letter

Submission Complete

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