Adding Initial IRB Approval Review Entry

Once the external IRB submission is approved:

• From the Menu, navigate to Protocols > PC Console and enter the protocol number in the Select Protocol search field.
• Click the Reviews vertical tab, and then the IRB horizontal tab.
• You should see an entry for a Request to Rely review from the WashU IRB. If this protocol has received HRPO approval. If not, email oncore@wustl.edu 
  
• In the Washington University in St. Louis review block, click Add (shown above) to manually enter the Initial Review.  You will be directed to an Update IRB Review page.
• Complete the following Required Fields in the Review Information block:
   

  • Review Date: date the external IRB reviewed/approved the WUSM site for this protocol.  Start typing the date and select from the drop-down menu (otherwise you will get an error).

  • Submit Date: date submitted for review (if this date is unknown, please use the Review Date again)

  • Committee: committee who completed the review. Options and descriptions below:

• • 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

  • Action: the action that resulted from the review (i.e., the committee's decision): Approved, Approval Released, Deferred, etc.

  • Action Date: date the external IRB released approval for the WUSM site to participate in the protocol

  • 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. 

Adding IRB Approved Documents

For documents reviewed by an external IRB, you will need to upload, at a minimum, the Protocol and approved Consent into the external review submission. Upload these documents into the external review submission. Do not upload these documents into the request to rely submission. 

• First, save the documents you will be uploading to your desktop (or a known folder). The following characters are not allowed in file names for documents added to OnCore  / \ : * ? < > 
• In the Details block, click Add.
  
• Add the protocol document and each consent that was approved as a part of the IRB submission. Include each consent type if there is more than one (e.g., Main Consent, Ancillary Consent, etc.)  
• Complete the following required fields in each consent entry: 
  • Type: Record of each approved consent must be entered here, to be available for use in Subjects console. Enter any/all consent records that are associated with each IRB review. 
  • Amendment No.: If applicable, this field indicates which protocol amendment number the documents is associated with.
  • Received date: Indicates the date the Regulatory Coordinator received the documents (not only the approval memo) from the IRB.  In rare cases (MedOnc, usually) it may indicate the date the review detail was received by the IRB; often the same date as the Submit Date in the Review Information block above.
  • Version date: Used to identify the most recent version of each document type for display in the document search.  This is the date the IRB approved the consent document and the Protocol version date for protocols.
  • Description and Comments are optional and may be added as needed.
• Click Save after each entry.

You should now see something like the below, with a hyperlink to Attach a File or URL (circled in red below) for each document type.

• 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 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.