...
Review Reason: in this case, select Initial Review
Review Type: this corresponds to whether the review was a Full Review or Administrative Review from the IRB of Record this should always be Facilitated for external IRBs.
Action: the action that resulted from the review (i.e., the committee's decision): Approved, Approval Released, Deferred, etc. the action should be Approval Released if the items were approved. Approved is only used for CRs.
Action Date: date date the external IRB released approval for the WUSM site to participate in the protocolemailed the approval documents.
Review Expires: This setting enables or disables the Expiration Date field for an IRB review.
When set to Yes, the date entered in the Expiration Date field will be used.
For reviews that will not expire, set to No; the Expiration Date field is disabled and no date is saved for the IRB review. The expiration dates will display as N/A in fields, headers, exports, and document/consent related areas throughout OnCore.
Expiration Date: date the review decision of the protocol expires.
When all details have been added, click Submit. You are ready to add the IRB approved documents to this review.
...
- Click on the File hyperlink. You will see a Choose File button appear (as shown below).
- Click on Choose File.
- You will be prompted to select the file from your computer. Locate the file, click on it, and press Open.
- Make sure your file has been added below the document details on the IRB Review (as circled below). Click Submit.
- You should now see the option to Release or Delete the file. Click the Release checkbox if this documents should be available in to make this document available to others and to send these documents to the PC Console > Documents/Info > Attachments/Links page. This does not apply to Consent Documents.
- When all documents associated with the review have been added, click Submit and Close.
...