Adding an IRB Review Entry

Once the external IRB modification or continuing review 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 at minimum a Request to Rely review from the WashU IRB and an Initial IRB Review from the External IRB.  If not, email oncore@wustl.edu. 
  
• In the Washington University in St. Louis review block, click Add to manually enter the External 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

  • 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: select Modification or Continuing Review, as appropriate

  • 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 modification or continuing review

  • 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. Only Expiration Dates associated with the Initial and Continuing Reviews will update the IRB Expiration Date displayed in the top right banner of OnCore.

When all details have been added, click Submit and Close

Adding IRB Approved Documents

For documents reviewed by an external IRB, you will need to upload, at a minimum, the Protocol, approved Consent, and when available, a Summary of Changes into the external review submission. You will be responsible for marking the Reconsent Required box for all studies, regardless of which IRB is used. Upload these documents into the corresponding external review 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 each consent and protocol document that was approved as a part of the IRB submission, including each type of consent form 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 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, the Protocol version date for protocols and Summary of Changes, and the Correspondence date for any Clarification memos.
  • Description and Comments are optional and may be added as needed.
  • Reconsent Required?: When adding a consent, there will be a checkbox option in the Reconsent Required column. 
    • If the review caused changes to the consent form that require subjects to be reconsented, selecting this box will flag all applicable subject in the CRA Console with an RR superscript, indicating to clinical coordinators that reconsent is required. The RR superscript will remain until the new consent is entered for that subject.
      
    • When this box is checked, a double arrow will appear next to it (image above). To narrow down which subjects the reconsent applies to, click the double arrows and a pop-up will appear listing subject statuses applicable to this protocol, including specific arms. Select only the statuses that require reconsent, and the RR superscript will only be applied to subjects currently in these statuses. All statuses will be selected by default.
      

• 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.
  
  
• The final step is to complete the Outside IRB Review Notification to CRBS only if new documents are available (consent, protocol, summary of changes, etc) with the review.