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.

When are continuing review reminders sent out?

PRAMS - 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.

CATS - Continuing Review (CR) reminder email notifications are sent to the PI, Primary Contact (if assigned) and PI Proxy(ies) (if assigned) 90, 75, 60 and 30 days prior to the approval end date of the study. These reminders are also logged in the history log of the study as part of the study record. Each of these notifications are the same and state that researchers must submit their continuing review or closeout information at least 45 days prior to the approval expiration date of the study.

When does the CR need to be submitted?

The due date for the Continuing Review is not the same as the approval expiration date of the research study.  Researchers must submit their continuing review or closeout information at least 45 days prior to the approval expiration date of the 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 CR to be submitted?

Continuing Reviews for studies that were originally submitted vie the eSubmission process are to also be submitted using PRAMS or CATS-IRB.  It is not necessary to re-upload the supporting documents, such as consent forms or recruitment materials as for the Office for Research Protections will obtain these documents directly from existing legacy documents.

How do I close my research study?

When your study has concluded, it is necessary to complete a Continuing Report (CR) in CATS-IRB to satisfy federal requirements that the research study is formally closed. The CR provides an option to close the study if renewed approval is not needed (for more information regarding this process, please see the "How do I Close out a Study" section within the Investigator Manual (HRP-103), which is also located in the CATS-IRB Library). For studies that originated via the PRAMS system and have not yet been converted into CATS-IRB, researchers will need to log into PRAMS to begin the continuing renewal process in order to close out the study.">CATS-IRB to satisfy federal requirements that the research study is formally closed.  The CR provides an option to close the study if renewed approval is not needed (for more information regarding this process, please see the "How do I Close out a Study" section within the Investigator Manual (HRP-103), which is located in the CATS-IRB Library).    

For studies that originated via the PRAMS system and have not yet been converted into CATS-IRB, researchers will need to log into PRAMS to begin the continuing renewal process in order to close out the study.