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Online Review

 

Figure 251 Protocol Document, Online Review Page
Figure 251 Protocol Document, Online Review Page

The Online Review page of a Protocol document appears as an additional tabbed page to the right of the Protocol Actions page when the document has been submitted to the ORIC and assigned to a review committee. This page consists of six sections and indicates who the primary and secondary reviewers are for the protocol and provides the ability to describe the purpose of the review. After being assigned to review a protocol, a reviewer will receive the request in their action list. A reviewer will review the assigned protocol and navigate to the Online Review tab to complete the official review of the protocol and add any review comments.

Document Overview

Figure 252 Protocol Document, Online Review Page – Document Overview Section
Figure 252 Protocol Document, Online Review Page – Document Overview Section

The Document Overview displays the basic identifying information about the protocol document such as the description, status, initiator, and date created.

Online Review

Figure 253 Protocol Document, Online Review Page – Online Review Section
Figure 253 Protocol Document, Online Review Page – Online Review Section

The Online Review section displays the first and last name of the reviewer assigned to the protocol, whether the reviewer is the primary or secondary reviewer, the date the review was requested, and the date the review is due by. The reviewer selects the recommended determination in the Determination Recommendation field by clicking the drop-down menu and selecting from the six options provided.

Determination Recommendation Description
Defer – Substantive Revisions Required IRB Reviewers will select this option if reviewing a Full Board or Expedited protocol that requires revisions before it can be approved.
Defer – Specific Minor Revisions ORIC staff members will select this option if reviewing a NHSR or Exempt protocol that requires revisions before it can be approved.
Approve Review of the Full Board protocol is satisfactory and should be approved by the IRB.
Expedited Approval Review of the Expedited protocol is satisfactory and should be approved by the IRB.
Grant Exemption - Acknowledged Review of the Exempt protocol is satisfactory and will be approved by IRB via ORIC staff review.
NHSR Acknowledged Review of the NHSR protocol is satisfactory and will be approved by the ORIC staff.

Table 80 Protocol Document, Online Review Page – Determination Recommendation Descriptions

General Feedback

Figure 254 Protocol Document, Online Review Page – General Feedback Section
Figure 254 Protocol Document, Online Review Page – General Feedback Section

Complete the General Feedback section, selecting the checklist you will be using to review the protocol. Be sure to indicate if you have a conflict of interest in reviewing this protocol. Click the save Complete the General Feedback section, selecting the checklist you will be using to review the protocol.  Be sure to indicate if you have a conflict of interest in reviewing this protocol.  Click the button after completing the checklist to save your work.

Review Comments

Figure 255 Protocol Document, Online Review Page – Review Comments Section
Figure 255 Protocol Document, Online Review Page – Review Comments Section

Provide any review comments regarding the protocol in the Review Comments section by clicking within the text box and entering text. If the comment is meant only for IRB members or ORIC staff to read, mark the comment private by clicking within the checkbox. Any comment not marked private will be able to be seen by the PI. Once the comment has been entered, mark the comment final.  Click the add add button to add the review comment to the protocol.

Review Attachment

Figure 256 Protocol Document, Online Review Page – Review Attachment Section
Figure 256 Protocol Document, Online Review Page – Review Attachment Section

If applicable, provide a review attachment. If providing an attachment, a description must be provided in the Description field. Locate the file to upload by clicking the browse button in the File Name Field. Click the add add button to add the file to the review.

Protocol Review Actions

Figure 257 Protocol Document, Online Review Page – Protocol Review Actions Section
Figure 257 Protocol Document, Online Review Page – Protocol Review Actions Section

Click the review complete button after adding comments, completing the General Feedback section, and making a determination recommendation.