Continuing Reviews. . .and a Final Note

As a courtesy, reminders of Continuing Review due dates are sent out automatically via email at 75 and 45 days prior to expiration. These reminders are sent only as a courtesy - ultimately, it is the investigator's responsibility to assure that their research studies are renewed each year and do not expire. Signed originals and copies (if applicable) need to be submitted by the due date designated on the email. The due date is not the same as the expiration date of the research study, and submitting materials after the due date may result in a delay that would necessitate stopping data collection or submission of a new application.

The Continuing Progress Report (CPR) for Continuing Review is attached only to the PI's email reminder. The text of the reminder is also emailed to other study team members - Co-I's, Project Coordinator, Advisors. The CPR is attached only to the PI's email so that duplicate CPRs are not submitted by more than one study team member. Modifications must be submitted separately from the CPR, unless the request is for a title change, removal of personnel or correction of typos on the informed consent form(s).

Submitting CPR materials for research reviewed at FULL LEVEL:
The original, completed and signed CPR, current consent form(s) and current recruitment materials must all be submitted in paper form to the ORP/IRB at 201 Kern Graduate Building, University Park, along with 17 copies of each of these items (collated and stapled). The CPR, current consent form(s) and recruitment material should also be submitted electronically to speed the return of the updated versions to you after review and approval from the full IRB. Send to ORProtections@psu.edu.

Submitting CPR materials for research reviewed at EXPEDITED and EXEMPT LEVELS:
The original, completed and signed CPR, current consent form(s) and current recruitment materials must all be submitted in paper form to the ORP/IRB at 201 Kern Graduate Building, University Park. The CPR, current consent form(s) and recruitment materials should also be submitted electronically to speed the return of the updated versions to you after IRB review and approval. Send to ORProtections@psu.edu.

Frequency of Continuing Reviews
Federal regulations require that expedited and full review level research studies be reviewed at least once per year (some studies may be reviewed more frequently, as determined by the IRB). Please be mindful of the due dates and be sure to meet them so that your research study can continue without interruption.

Concluding Your Research Study
When your study has concluded, it is necessary to complete either the CPR or a Project Closeout Form to satisfy federal requirements that the research study is formally closed. The Project Closeout Form is used if the continuing review date is not imminent. The link for the Project Closeout Form can be found under "Other Forms" at http://www.research.psu.edu/orp/areas/humans/applications/index.asp#other

Record Retention
As you wrap up your study, remember to retain all research records for at least 3 years. Other timelines may apply, depending on the type of study and records, as well as what was approved on your application, so check your IRB application/approval and the Record Keeping link for more information: http://www.research.psu.edu/orp/areas/humans/policies/investigatormanual/ch9.asp#f

A Final Note!

When contacting (phone, email) the Office for Research Protections, always have your IRB number at hand. This 5-digit number appears in all correspondence from the ORP/IRB and should be included in all correspondence to the ORP/IRB. By having the number readily at hand when you call and including it in all emails, personnel at the ORP can quickly access your study from the thousands of studies listed in PRAMS (the electronic management system).

Go to