How to Submit Continuing Review

Timeline for Continuing Review

• Continuing review is required, not less than once per year, for all submissions determined to be greater than minimal risk by the Institutional Review Board.
• Minimal risk research reviewed under the old Common Rule (pre-2018) requires continuing review, not less than once per year, unless the IRB has determined that continuing review is no longer required.
• Minimal risk research reviewed under the 2018 Common Rule (submitted after January 2019) generally does not require continuing review. However, as permitted by the 2018 Common Rule, continuing review may be required by the IRB for some research, such as FDA regulated research. In this case, continuing review is required not less than once per year.

When continuing review is required, the expiration date for a submission is noted in the original approval letter and will be provided on the stamped informed consent form.

How to Submit Continuing Review

This section details instructions on how to submit a continuing review submission.

The Continuing Review application in eIRB is a Smartsheet and the questions that have a asterisk are required fields. The IRB review is dependent on all the required fields and sections being completed. The IRB is no longer accepting emailed CR submissions for legacy paper records. All CR submissions should be submitted in eIRB. 

Please note that a standalone progress report document is no longer a requirement when submitting the CR application in eIRB. The progress report should be added to the “II. Project Summary: section in the CR application. Please include the following information in the Project Summary section:

• • A narrative summary of the study activities that occurred during the approval year including notable comments, notable subject experiences, any delays in study activities, and expected activities for the coming year. Please do not re-iterate the enrollment numbers provided in this form unless a specific clarification is needed.

  • If applicable, a summary of any deviations that required expedited reporting in the past year.

  • If applicable, a summary of any adverse events that required expedited reporting in the past year.

  • A summary of any planned/outstanding amendments that will be submitted to the IRB for review including the planned timeline for submission and the impact the changes have for enrolled subjects, as applicable.

     

Study Monitoring/Quality Control section:

Penn Medicine Research: For Greater Than Minimal Risk protocols where there is no sponsor appointed monitor, complete the PICA via REDCap. The PICA can be completed by any member of the study team, but PI review and confirmation via signature is required. If you have questions about the PICA form, please contact OCR Compliance at psom-ocrcompliance@pobox.upenn.edu. Do not submit the PICA to the IRB.

• A Deviation Log is required when there is no Sponsor appointed monitor, i.e., the PI and study team are conducting all quality control activities. Please be sure to include these logs/reports in the Continuing Review Additional document section in eIRB for IRB review. Verification that the PICA has been submitted via RedCep for OCR review is required to be checked off in the CR application as well. 

• A Deviation Log is NOT required when the Regulatory Sponsor’s designated study monitor is conducting quality control activities by reviewing the study records and there is an independent monitoring entity. A PICA is also not required.

Safety Monitoring / AE Assessment section:

• AE logs are not required, but could be requested by the IRB. Summarize events that required expedited reporting in your progress report, as applicable.

Document Requirements

If your eIRB record is complete, including the uploading of your current study documents (i.e., protocol, consent, IB, package insert, device brochures, other patient facing materials, etc.) into the record, you do not have to re-upload your study documents into the continuing review form. 

If your eIRB record is NOT complete, please upload your current study documents into the continuing review form. 

• Please ensure that all documents provided are in a searchable format, and not a scanned PDF. It is the responsibility of the study team to keep current editable versions of study documents in case changes to study documents are needed.

• Please ensure that consent form(s) are submitted in Word version (preferred) or searchable PDF format. Please do not submit the currently stamped version of the consent form, as the document has to be re-stamped. Additionally, please ensure that there is no text in the footer bottom center of the consent form, eIRB automatically stamps the consent forms now and will stamp over any existing text in the bottom center of the footer.

• The IRB strongly recommends the file names of the documents indicate the protocol number, type of document (e.g., Full Protocol; Informed Consent Form), and the date). This will facilitate IRB review processes.

If a study lapses in approval at any time, research related activities must cease immediately, including enrollment of participants.

What if my study is expired / lapsed in approval?

Click below for guidance on lapsed approval and other continuing review frequently asked questions (FAQs).