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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. 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.
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- 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.
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- 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.
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