Transferring Paper Studies to Penn eIRB
All active protocols that were approved by the IRB either by paper submissions or emails must be entered in Penn eIRB. The IRB will no longer review email submissions. This includes amendments to paper protocols, and FDA updates to expanded access single patient treatment use. Please see below for further information.
Completeness QA for Approved Paper Protocols
All paper protocols that are approved and active have been migrated to Penn eIRB with minimal information.
In Penn eIRB all study teams managing paper protocols will need to:
- Complete the full eIRB application via an Amendment submission or an Amendment+Continuing Review combo submission (if you are due for a Continuing Review); and
- Upload all current documents; and
- Include a cover letter that outlines:
- Purpose of the submission (e.g. record completion, amendments to protocol and record completion, etc.)
- If submitting an amendment, differentiate between documents being uploaded for application completeness versus documents being revised to facilitate IRB review.
- List of any uploaded documents
It is recommended that study teams plan ahead and assess their inventory of paper protocols to determine their own time and effort to conduct this activity.
For information if your paper study should be completed in Penn eIRB please email Heather Emery at heathern@upenn.edu.
For Expanded Access Single Patient Treatment Use Requests, there is a new Single Patient Treatment Use Submission that mirrors the paper form. Active protocols should be updated in Penn eIRB.
All emailed Single Patient Treatment Use (SPTU) protocols that are approved and active have been migrated to Penn eIRB with minimal information. If you have a patient actively receiving treatment you will need to complete your protocol in Penn eIRB.
In Penn eIRB all study teams with active SPTU protocols will need to:
- Complete the full eIRB application via an Amendment submission
- Upload all current documents; and
- Include a cover letter that includes:
- Purpose of the submission (e.g. record completion, or record completion and FDA update)
- Document List of any uploaded documents to be included in letter
NOTE: The eIRB system will be available on 2/09/2026; to transfer the Single Patient Treatment Use Protocol to the eIRB, enter the IRB legacy protocol number and use the new Single Patient Treatment Use Application that mirrors our current paper form and upload all current documents to the eIRB application.
If you are unsure if you need to complete your submission, please contact Diane Pinder at pinder@upenn.edu.
How to Submit
Step by step instructions on how to submit your revised documents in eIRB as well as how to revise the eIRB application.
- Go to eIRB.
- To request an amendment, scroll to the top of your protocol in eIRB and look for a series of blue boxes and select the “New Amendment” box.
- You now have the option of selecting a New Amendment or Continuing Review OR a New Amendment based on the type of study/expiration date.
- Click “Request” to open the e-Amendment Form and you will complete the “Create New Amendment” sheet.
- Select the “Type” of form you are filling out using the dropdown arrow. (Note you may ignore this step if the form type auto-filled correctly.)
- Select the type of change you are requesting using the search or dropdown menu. (i.e. Research Team for this example). Note you may select multiple changes at one time.
- Complete the rest of the fields as necessary. Make sure to indicate whether the current amendment changes the content of the consent form.
- To continue click “Save” in the bottom right corner of the e-form.
eIRB Instructional Walkthrough