Clinical Research Times

March 28, 2024

Dear Colleague:

This month’s Feature Article discusses the process for submitting a Status Check-In Report for Expedited, Exempt, and Ceded research studies that do not require annual continuing review. We will also discuss a new policy that permits Principal Investigators to close Exempt research without submitting a Final/Closure Report.

Also check out:

• “Things to Know”  on new and revised HRPP Policies and Procedures that took effect this month; and a notification from the BMC Clinical Data Warehouse for Research (CDW-R) about upcoming CDW-R downtime, including a delineation of the services that will continue, and the services that will be impacted
• “The CRRO Corner” on best practices related to protocol deviations; how to document and report protocol deviations that are identified, as well as strategies for preventing future deviations
• “Getting to Know ClinicalTrials.gov” on “Good Cause Extension” requests for extending the results reporting deadline for Applicable Clinical Trials (ACTs) and NIH-funded clinical trials
• “Spotlight on SOPs” on protocol deviation reporting
• “Dear IRB” for guidance on creating a repository study to support the conduct of separate retrospective chart review studies that seek to use the same dataset

Learn more at www.bu.edu/crtimes.

Matthew Ogrodnik, MS, CIP, Editor, CR TIMES
Director, Office of Human Research Affairs