Documents Update for Closure
Consent documents must be removed from the Documents/Info section of the PC Console after the study is closed to accrual.
Creating a Submission
From the Menu, navigate to ePRMS > Submission Console
Under the Create Submission vertical tab, choose Continuation review (Renewal), Change review (Amendment), or Closure as appropriate.
A new form to create your review will open. In the Review type field, choose from the drop down. (If unsure, choose Admin.)
In the Protocol No. field, enter the study HRPO/IRB number, then click the magnifying glass box () and select your protocol.
Click Create Submission.
Updating a Submission
In the Competing Protocols block, enter any competing studies in order of priority. If none, check the box for No competing protocols.
In the Documents block:
- Complete the following required fields:
- Document type
- Description
- Version Date
- Expiration Date (if applicable)
- Attach the following required documents:
- Consent form (if revised)
- Investigator Brochure (if revised)
- myIRB Application
- Protocol (if revised)
- PRMC Form, as required, found on the PRMC website
- any other required documents
Special Characters
The following characters are not allowed as part of file names for documents added to OnCore:
/ \ : * ? < > .
Click Add after selecting each document to be uploaded.
Sending a Submission
When finished updating the submission, click Send at the bottom of the page.
You will see an alert when the submission is sent to PRMC. Also, you will receive email notifications as the submission moves through the review process.
Deleting a Submission
If you have created a submission in error or you wish to remove a submission for any reason (i.e., delete it), you may choose the Withdraw option instead of Send in the bottom right corner of the page.