Uploading Documents - Who is Responsible?
Documents should be uploaded within seven days of IRB Approval. This is consistent with current WashU IRB requirements to activate an approved modification.
- When WashU is the IRB of Record
Protocol and Consent documents are now auto-added via the integration with myIRB. Prior to April 22, 2022, Clinical Research Billing Support manually uploaded documents.
- The Regulatory Coordinator for the protocol will release any documents that should be available via the document search and (if not a Consent ) in the PC Console > Documents/Info > Attachments/Links page.
- When an External IRB is used:
- The Regulatory Coordinator for the protocol is responsible for uploading documents. Make sure the most up-to-date protocol and consent documents are uploaded to the IRB review as detailed below.
- The Regulatory Coordinator for the protocol will release any documents that should be available via the document search and (if not a Consent) in the PC Console > Documents/Info > Attachments/Links page.
Study Identifiers for External IRBs in OnCore
Protocol No. = HRPO Number (Menu > Protocols > PC Console > Main > Details)
IRB No. = IRB of Record Number (Menu > Protocols > PC Console > Main > Management)
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:
IRB Committee | IRB Committee Description |
WU-IRB | our local WashU IRB |
Affiliate Site IRB | a non WashU IRB that provides review only for the researchers for its organization |
Advarra Central | an IRB (Advarra) that provides review services for multiple sites participating in a trial and is not affiliated with a research organization. Sponsor is submitting to Commercial IRB on behalf of WashU |
Western IRB Central | an IRB (also referred to as WCG IRB) that provides review services for multiple sites participating in a trial and is not affiliated with a research organization. Sponsor is submitting to Commercial IRB on behalf of WashU |
Advarra Local | an IRB (Advarra) that provides review services for multiple sites participating in a trial and is not affiliated with a research organization. WashU is initiating the submission to the Commercial IRB. |
Western IRB Local | an IRB (also referred to as WCG IRB) that provides review services for multiple sites participating in a trial and is not affiliated with a research organization. WashU is initiating the submission to the Commercial IRB. |
Other Commercial IRB | a commercial IRB aside from Advarra or Western IRB |
NCI Central IRB | an NCI IRB that provides review services for multiple sites participating on a trial |
Other CIRB | a central IRB that provides review services for multiple sites participating in a trial |
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
Expiration Date: date the review decision of the protocol expires. If no expiration date please use common change rule and enter 12/31/2099.
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 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 if this documents should be available in 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.