Online Review (Assigned Reviewer view)

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Online Review (Assigned Reviewer view)

Once reviewers are assigned to a protocol by the IRB Administrator, each reviewer will be able to access an Online Review page where they can provide review comments, review attachments and a review determination. Each reviewer has access only to their own review.

Online Review (IRB Administrator versus Assigned reviewer view): 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.

Figure 1238 Protocol Document – Assigned Reviewer View - Online Review Section

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

Figure 1239 Protocol Document – Assigned Reviewer View - Online Review – Document Overview Section

Online Review: The Online Review section displays key information pertaining to the review and also allows the reviewer to provide a determination recommendation for the protocol assigned to them.

Figure 1240 Protocol Document – Assigned Reviewer View - Online Review – Online Review Section

Table 433 Protocol Document, Online Review Page – Reviewer View - Online Review Field Descriptions

Field	Description
Reviewer	Display only. The Reviewer field displays the name of the reviewer.
Requested Date	Display-only. The Requested Date displays the date the online review request was created. It is auto populated by the system upon creation of Online Review.
Status	Display only. The Status field shows the document status of the Online Review document.
Due Date	Display only. 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.
Determination Recommendation	This field allows the reviewer to provide an optional recommendation to the IRB Administrator for the protocol assigned to them for review. Select a recommendation from the list of options available (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	Display only. 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 Review Comments section allows the reviewer to select a standard comment or enter comments manually within the comment box. After the Comment box is populated with comments, the Add button needs to be clicked. The reviewer can add multiple comments in this section.

Each review comment added by the reviewer has a private and final flag associated to it. Reviewers cannot see the private and final flags attached to each review comment. The private flag controls review comment visibility by researchers. The final flag indicates that IRB administrator has reviewed and finalized the comment. Once review comments are submitted by the reviewer, the IRB Administrator can override the default private and non-final setting of the comment.

Figure 1241 Protocol Document – Assigned Reviewer View - Online Review – Review Comments Section

Table 434 Protocol Document, Online Review Page – Reviewer View – Review Comments Field Descriptions

Field	Description
Standard Comment	Select and return a predefined comment from the Protocol Contingency Lookup screen. 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	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.
Actions	Click the add button to add your attachment as a row in the table below, which will become a numbered line item.

Review Attachment: The Review Attachment section allows reviewers to add attachments as part of their protocol review. After a description has been provided and a file selected, the Add button needs to be clicked. The reviewer can add multiple attachments as part of their protocol review.

Each review attachment has a “Protocol Personnel can view” indicator associated to it. Reviewers do not have access to update this indicator. Once the reviewer submits their Online Review, the IRB Administrator can set the “Protocol Personnel can view” indicator on the reviewer attachment based on whether or not they want protocol personnel to see the reviewer attachment.

Figure 1242 Protocol Document – Assigned Reviewer View - Online Review – Review Attachments Section

Table 435 Protocol Document, Online Review Page – Reviewer View – Review Attachments Field Descriptions

Field	Description
Description	Enter text that 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	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.
Actions	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: As the reviewer is performing their Online Review, they can save their review periodically. Once the review is complete, the reviewer must approve their review in order to indicate their review is complete and ready to be processed by the IRB Administrator.

Once the reviewer has started their Online review, the system will display a warning to the user indicating to the user that they must click on the Approve Review button in order to complete their review.

Figure 1243 Protocol Document – Assigned Reviewer View - Online Review – Protocol Review Actions

Table 436 Protocol Document, Online Review Page – Reviewer View – Protocol Review Actions Field Descriptions

Field	Description
Save	Click the save button to save your review.
Approve Review	Click the approve review button to finalize your review.