Continuing Reviews

When and why are Continuing Reviews done?: Federal regulations require that expedited and full review level research studies must 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.

Who gets the Continuing Progress Report (CPR)?: Only the Principal Investigator (PI) receives the email with the CPR form attached. Other study team members receive the email reminders, but not the attachment. This is to avoid multiple CPR forms being completed/returned.

When are Reminders sent out?: 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.

Who is to submit the CPR?: The PI, a Co-Investigator, a Project Coordinator or an Advisor can submit the CPR form. If the CPR form is not submitted by the PI, it is expected that (1) the PI has read and concurred with the information in the CPR form AND (2) the PI must be copied on the email. The IRB number needs to appear in the subject line of the email. Please note that signatures are no longer required on the CPR form.

What are the supporting documents that need to be submitted along with the CPR?: The supporting documents are the current, approved informed consent/assent form(s) and the current, approved recruitment materials (if applicable, per question #7 on the CPR).

When does the CPR need to be submitted?: The due date for the CPR is not the same as the approval expiration date of the research study. Submitting materials after the due date may result in a delay that would necessitate stopping research activities and/or submission of a new application.

How is the CPR to be submitted?: Applications for all new studies must now be submitted through the IRB eSubmission system, PRAMS. Continuing Reviews for studies that were originally submitted in PRAMS should also be submitted using PRAMS. For studies submitted through the IRB eSubmission system, it is not necessary to re-upload the supporting documents, such as consent forms or recruitment materials. The Office for Research Protections will obtain these documents directly from PRAMS.

The CPR form for continuing reviews for studies that were originally approved in paper (and other supporting documents, if applicable) may be mailed to The 330 Building, Suite 205 or submitted as an email attachment to ORProtections@psu.edu (all documents are to be contained within one email message). Please note that signatures are no longer required on the CPR form.

What about modification requests?: Modification requests must be submitted separately from the CPR form, unless the request is for a title change, removal of personnel, or correction of typos on the informed consent form(s). Any modifications that do not fall into one of these 3 categories must be submitted separately.

How do I close my 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 at Closeout Forms
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