Clinical Research Times

June 30, 2024

Dear Colleague:

“Chart reviews” are research studies that only involve data that have been collected, or will be collected, solely for non-research purposes (such as medical treatment or diagnosis). Chart reviews are one of the most common types of research studies submitted to the Boston Medical Center/Boston University Medical Campus Institutional Review Board (BMC/BUMC IRB). This month’s Feature Article discusses chart review research, and provides detailed step-by-step instructions on how to complete the IRB application for this type of study.

Also check out:

• “Things to Know” on new and revised HRPP Policies and Procedures that took effect this month; a reminder about the modified requirements for research involving publicly available data; and a reminder about the new process for closing exempt studies without the need for submission of a Final/Closure Report form
• “The CRRO Corner” on using self-assessment processes and available tools for monitoring compliance with study procedures and study documentation to maintain high quality research
• “Getting to Know ClinicalTrials.gov” on the implementation of the modernized ClinicalTrial.gov website and the subsequent retirement of the classic website
• “Spotlight on SOPs” on the Standard Operating Procedure (SOP) entitled “Essential Research Documents”, which describes requirements for the essential documentation in regulatory and participant files, and provides guidance in the management of this documentation throughout the course of a study
• “Dear IRB” on data retention and destruction, as well as how to locate your study’s expiration date in the INSPIR system

Learn more at www.bu.edu/crtimes.

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