彩民宝典

All expedited and full board studies are approved for one year or less, depending on the level of risk. Investigators must submit a Continuing Review submission in eRA to request continuation of research activities beyond the expiration date.听

A study will usually undergo the same level of review for initial and continuing review. For example, a study that was originally reviewed using the expedited review procedure will usually undergo its continuing review on an expedited basis.

Studies certified as exempt are not required to undergo Continuing Review. Continuing Review provides an opportunity to fully reassess the study and ensure the research continues to meet the criteria for IRB approval.

The study expiration date is included in approval letters from the IRB. As a courtesy, 彩民宝典's IRB Office sends out reminder emails before the expiration date; however, it is the investigator鈥檚 responsibility to monitor approval/expiration dates to ensure IRB approval does not expire. Research activities can continue while the IRB reviews the Continuing Review submission听as long as the expiration date has not passed. As such, the IRB recommends Continuing Reviews be submitted 30 days before the expiration date to allow sufficient time for the review process.

There is no grace period extending the conduct of the research past the expiration date.听Extensions will not be granted.听All study research activities听must stop after the expiration date. IRB approval must be obtained before the research activities can resume. If a study is expired for more than 90 days, the study will be administratively closed by the IRB Office. A new application may be submitted for the continuation of the project, which will go through IRB review.

Requirements

Investigators must complete a Continuing Review Form in eRA and submit the following documentation as applicable:

• A copy of the most recent monitoring report, if the study is overseen by an independent monitoring body (e.g., Data Safety Monitoring Board report, Data Monitoring Committee report)
• Any relevant recent literature听
• Any relevant multi-center trial reports
• IND reports

Note: DO NOT submit updated or revised research documents (Protocol, Consent Forms, etc) in your Continuing Review. These documents must be submitted in a separate Amendment Submission.

For step-by-step instructions for creating and submitting a Continuing Review submission refer to the eRA Continuing Review Submission Guide.