Versions Compared

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.

...

Info
titleDocuments 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

  1. From the Menu, navigate to ePRMS > Submission Console
  2. Under the Create Submission vertical tab, choose Continuation

...

  1. Review (Renewal), Change

...

  1. Review (Amendment), or Closure as appropriate.

...

  1. Image Modified

  2. A new form to create your review will open. In the Review

...

  1. Type field, choose from the drop down.

...

  1. If unsure, choose Admin.

...

  1. In the Protocol No. field, enter the study HRPO/IRB number, then click the magnifying glass box (Image Modified) and select your protocol.

    Image Modified

  2. Click Create Submission.

 

 

Updating a Submission

  1. In the Competing Protocols block, enter any competing studies in order of priority. If none, check the box for No competing protocols.
  2. In the Documents block

...

  1. , complete the following required fields:
    1. Document type
    2. Description
    3. Version Date
    4. Expiration Date (if applicable)

...

  1. Upload the

...

  1. PRMC 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

...

  1. to the Documents block.  For a list of PRMC required documents, please reference PRMC Submission Forms and Instructions.
  2. Click Add after selecting each document to be uploaded.

Warning
titleSpecial Characters

The following characters are not allowed as part of file names for documents added to OnCore:

/ \ : * ? < > .

 

...

.

Sending a Submission

  • When finished updating the submission, click Send at the bottom of the page.
  • 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.