Online Review (IRB Administrator view)

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Online Review (IRB Administrator view)

The Online Review page of the Protocol document appears as an additional tabbed page to the right of the Protocol Actions page when the IRB Administrator assigns the protocol to a committee (Submission status is Submitted to Committee).

Create New Online Review: It allows you to specify a reviewer, select the Reviewer Type and establish a due date for a new online review of the protocol. An explanation field gives you the ability to describe the purpose of the review. After specifying this basic information and clicking the create button provided, the reviewer will receive the review request in their action list.

Online Review (IRB Administrator and Assigned reviewer views: While each assigned reviewer can access only their individual reviews through the Online Review page, the IRB Administrator can access and manage all the assigned reviewer’s reviews through the Online Review page.

‘IRB Review’ Node - Workflow Implementation Requirement: For Protocol workflow routing to function properly, the ‘IRB Review’ Route (workflow) Node is essential. For the Committee review / IRB approval, this node is required to be present and last for IRB Protocol.

Figure 1228 Protocol Document, Online Review Page Example

Table 428 Protocol Document, Online Review Page - Create New Online Review Section Field Descriptions

Field	Description
Reviewer	Required. Select an individual person to be the recipient of the new online review action request. Use the drop-down menu by clicking the down arrow to display the list, and then click on an item in the list to highlight and select it to populate the box with your selection.
Reviewer Type	Required. Select the reviewer type (primary, secondary) for each reviewer. Use the drop-down menu by clicking the down arrow to display the list, and then click on an item in the list to highlight and select it to populate the box with your selection.
Description	Required. Enter identification text that serves as a brief summary of the purpose of the review. Click within the text box (or press the tab key from a previous field) to relocate the cursor to the field, and then type (or paste from virtual clipboard) to enter text in the box as necessary to provide the appropriate information.
Organization Document Number	Type the desired number for an associated document outside the KC system as necessary according to your institutional requirements. Click within the text box (or press the tab key from a previous field) to relocate the cursor to the field, and then type (or paste from virtual clipboard) to enter text in the box as necessary to provide the appropriate information.
Requested Date	Display-only. The date the new online review request was created.
Due Date	Enter the date the new online review is due from the specified Reviewer. Click the calendar icon to select, or type in mm/dd/yyyy format to populate the box with the desired date.
Explanation	Enter a textual explanation that expands on the Description in greater detail to make the review’s purpose clear. Click within the text box (or press the tab key from a previous field) to relocate the cursor to the field, and then type (or paste from virtual clipboard) to enter text in the box as necessary to provide the appropriate information. Click the add note icon to view/edit/paste text in a new browser window, then click the continue button to return to the text entry field in the document. After saved, click the green arrow symbol to view full text in a separate browser window.

Online Review Section

After filling out the required fields in the Create New Online Review section and clicking the create button, a new tabbed section appears below it name Online Review: First, Last (where First, Last displays the name of the Reviewer). For each assigned reviewer, the system generates an Online Review section. The Online Review page accessible to the IRB Administrator aggregates the Online Review sections for all the assigned reviewers’ one below the other.

Figure 1229 Protocol Document – Online Review Section Example

Manage Online Reviews

As assigned reviewers perform their Online Reviews, the system aggregates each reviewer’s Online Review within the Online Review page for the IRB Administrator to manage. The IRB Administrator can access to both in progress reviews and completed reviews within the Online Review page. Depending on whether the Online Review is in progress or completed, the IRB Administrator can perform a variety of actions on the Online Review. They can approve e the review, accept the review comments, delete the review, return it to the reviewer for further changes, change private and final setting and also enter comments on behalf of the reviewer. The Online Review for each assigned reviewer is stacked one below the other in the Online Review page for the IRB Administrator.

The system helps the IRB Administrator distinguish completed reviews from in-progress reviews within the Online Review section. In progress reviews have a warning message displayed and a document status of Saved within the Online Review sub-section. The IRB Administrator is limited to Approve Review and Delete Review actions on an in-progress review. In contrast, Online reviews that have been completed by the reviewers have a document status of Final within the Online Review sub-section. The IRB Administrator can perform Accept Review comments , Return the review or Delete the review actions on completed reviews.

Figure 1230 Protocol Document – Online Review Section – Manage Online Reviews

Document Overview: The document overview contains identifying information about the Online Review document assigned to the reviewer. All the fields are read only.

Figure 1231 Protocol Document – Online Review Section – Manage Online Reviews- Document Overview

Online Review: The Online Review section displays key information pertaining to the review and reviewer and includes the determination recommendation made by the reviewer. The IRB Administrator can override the recommendation provided by the reviewer and also change the reviewer type, due date and requested date from within this section.

Figure 1232 Protocol Document – Online Review Section – Manage Online Reviews – Online Review section

Table 429 Protocol Document, Online Review Page – Online Review Field Descriptions

Field	Description
Reviewer	Display only. The Reviewer field displays the name of the reviewer.
Requested Date	The Requested Date displays the date the online review request was created. It is auto populated by the system upon creation of Online Review. The requested date can be updated.
Status	Display only. The Status field shows the document status of the Online Review document. A Final status indicates that the reviewer has completed their review. Saved status indicates that the review is in progress.
Due Date	The Due Date displays the date the review is due. It is populated only if the IRB Administrator specifies a due date for the Online Review. The Due Date for a reviewer can be updated from within this section.
Determination Recommendation	This field displays the Determination Recommendation provided by the reviewer. It can be overridden by the IRB Administrator or entered by the IRB Administrator on behalf of the reviewer. The selection options are (Specific Minor Revisions, Substantive Revisions Required, Approve, Expedited Approval, Grant Exemption, Close Administratively, Terminate and Disapprove). Use the drop-down menu by clicking the down arrow to display the list, and then click on an item in the list to highlight and select it to populate the box with your selection.
Reviewer Type	The reviewer type specifies whether the assigned reviewer is primary or secondary. All assigned reviewers must be assigned a primary or secondary reviewer type.

Review Comments: The IRB Administrator can view and manage the review comments provided by the assigned reviewers within the Review Comments section. The IRB Administrator can edit the comments, change the private/final setting on each comment, re-arrange the order of the comments and delete the comment. Review comments can also be entered by the IRB Administrator on behalf of the reviewer. Any changes made by the IRB Administrator will be tracked and noted by the system within the Last Updated By column.

Figure 1233 Protocol Document – Online Review Section – Manage Online Reviews – Review Comments section

Table 430 Protocol Document, Online Review Page – Review Comments Field Descriptions

Field	Description
Standard Comment	For manually entered comments, the Standard Comment column will display n/a. If the IRB Administrator chooses to override a standard comment entered by the reviewer or add a new comment they can click the lookup icon to search for and return the value to populate the box automatically, or if known, type the value in the box.
Comment	Reviewer entered comments are displayed within the Comment box. The IRB Administrator can edit comments made by reviewers or enter comments on behalf of the reviewer. Click within the text box (or press the tab key from a previous field) to relocate the cursor to the field, and then type (or paste from virtual clipboard) to enter text in the box as necessary to provide the appropriate information. Click the add note icon to view/edit/paste text in a new browser window, then click the continue button to return to the text entry field in the document. After saving, click the green arrow symbol to view full text in a separate browser window.
Private	The private flag on a review comment indicates that protocol personnel will not be able to view the comment. By default, all reviewer entered comments will have the Private flag checked. The IRB Administrator can override the private flag setting on a review comment. Click within the checkbox to select the item. A check mark appears within the checkbox to indicate the item is selected. Click within the checkbox again to clear the mark and deselect the item.
Final	The final flag on a review comment indicates that the IRB Administrator has completed processing the comment and it can appear on all official communication related to the protocol if it is non-private comment. By default all reviewer entered comments are marked as non-Final. The IRB Administrator can override the final flag setting on a review comment. Click within the checkbox to select the item. A check mark appears within the checkbox to indicate the item is selected. Click within the checkbox again to clear the mark and deselect the item.
Last Updated By	Display only. The user who last updated the comment and the timestamp of update is displayed in this column. If the IRB Administrator updates a reviewer’s comment, the system overrides this column with the IRB Administrator’s user name and time stamp of update.
Created By	Display only. The user who created the comment and the timestamp of creation is displayed in this column.
Actions	For reviewer entered comments, the IRB Administrator is allowed to reorder the comments and delete it from within the Actions column. Click the delete button to remove a previously-added line item row from the table. Click the up/down arrow buttons as necessary to adjust the line item order. If an IRB Administrator is entering comments on behalf of the reviewer, the actions column will contain an Add button. Click the add button to add your selection to as a row in the table below, which will become a numbered line item. For more information about basic line item functionality, see “Common Line Item Operations” in Common E-Doc Operations.

Review Attachment: The IRB Administrator can view and manage review attachments added by the assigned reviewers within this section. The system allows the IRB Administrator to view, delete and control visibility of the review attachment by protocol personnel.

Figure 1234 Protocol Document – Online Review Section – Manage Online Reviews – Review Attachments section

Table 431 Protocol Document, Online Review Page – Review Attachment Field Descriptions

Field	Description
Description	The IRB Administrator can modify the text description entered by reviewers or enter a description if they are adding an attachment on behalf of the reviewer. The text entered describes the attachment. Click within the text box (or press the tab key from a previous field) to relocate the cursor to the field, and then type (or paste from virtual clipboard) to enter text in the box as necessary to provide the appropriate information.
File Name	For attachments added by the reviewer, this field is display only. It displays the name of the file added by the reviewer. The IRB Administrator can also add an attachment on behalf of the reviewer. Click the Browse button. In the File Upload dialog box (Windows), use the Look in: dropdown menu to locate the file, click on the file to highlight and select it, then click the Open button. The File Name field now displays the directory, folder path and filename you selected.
Protocol personnel can view	This field controls whether or not protocol personnel can view the review attachment. By default all review attachments added by the reviewers have the Protocol personnel can view field unchecked – to prevent protocol personnel from viewing the review attachment. The IRB Administrator can override this field. Click within the checkbox to select the item. A check mark appears within the checkbox to indicate the item is selected. Click within the checkbox again to clear the mark and deselect the item.
Last Updated By	Display only. The user who last updated the review attachment and the timestamp of update is displayed in this column.
Created By	Display only. The user who created the review attachment and the timestamp of creation is displayed in this column.
Actions	For reviewer added attachments, the IRB Administrator is allowed to view or delete the review attachment from within the Actions column. Click the view button to open and view the attachment. Click the delete button to remove a previously-added line item row from the table. The IRB Administrator can also add review attachments on behalf of the reviewer, Click the add button to add your attachment as a row in the table below, which will become a numbered line item.

Protocol Review Actions: Once the reviewer has marked their review complete, the IRB Administrator can accept all review comments, delete review or return the Online Review back to the reviewer. If the review has not been completed by the reviewer, the IRB Administrator first needs to approve the review before other actions become available,

• Accept Review comments: The Accept review comments action indicates that the IRB Administrator has finalized all the review comments. After this action is activated, the system removes other actions such as Delete review and Return to reviewer and only allows the IRB Administrator to save changes they might make to review comments. The Accept Review comments action also automatically sets the Final flag on all review comments.

• Delete review: Delete review removes the review comments, review attachment and determination recommendation provided by the reviewer. Prior to deleting the Online Review the system prompts the IRB Administrator with a warning message and a comment box to enter the reason for the delete review action. The IRB Administrator is provided with a choice to proceed with the delete or abandon the action.

Delete Review Notification: If the notification for Delete review action has been activated by an implementing institution, the reason for the delete action entered by the IRB Administrator is sent as part of the message body of the notification.

Figure 1235 Protocol Document – Online Review Section – Manage Online Reviews – Delete Review warning

• Return to reviewer: The Return to reviewer action allows the IRB Administrator to return the Online Review document back to the reviewer for corrections. Once returned back the reviewer can make changes to the review comments, review attachment and determination recommendation and submit it again to the IRB Administrator. Prior to returning the Online Review the system prompts the IRB Administrator with a warning message and a comment box to enter the reason for the return to reviewer action. The IRB Administrator is provided with a choice to proceed with the return to reviewer or abandon the action.

Return to Reviewer Notification: If the notification for return to reviewer action has been activated by an implementing institution, the reason for the return to reviewer action entered by the IRB Administrator is sent as part of the message body of the notification.

Figure 1236 Protocol Document – Online Review Section – Manage Online Reviews – Return to Reviewer warning

Figure 1237 Protocol Document – Online Review Section – Manage Online Reviews – Protocol Reviewer Actions

Table 432 Protocol Document, Online Review Page – Protocol Review Actions Field Descriptions

Field	Description
Save	Click the save button to save your review.
Accept Review Comments	Click the accept review comments button to finalize review comments. Once activated only the save button will be available.
Delete Review	Click the delete button to delete the Online Review submitted by the assigned reviewer. The system prompt the user for a reason for the delete review action.
Return to Reviewer	Click the return to reviewer button to return the review back to reviewer to make changes to their Online Review. The system prompt the user for a reason for the return to reviewer action.