Clinical Research Times

September 25, 2024

Dear Colleague:

The National Science Foundation (NSF) has made two new significant changes to their required training for the responsible conduct of research (RCR). This month’s Feature Article discusses these changes, and provides information on resources available to satisfy these RCR training requirements.

Also check out:

• “Things to Know” on updated Exempt Information Sheet templates that include Abbreviated HIPAA authorization language; new and revised HRPP Policies and Procedures that took effect since the last June 2024 issue of the CR TIMES; 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 upcoming trainings (Fundamentals in the Conduct of Clinical Research and Principal Investigator Role training), as well as the Clinical Research Seminar and RPN calendars for the remainder of 2024
• “Getting to Know ClinicalTrials.gov” on the implementation of the modernized Protocol Registration and Results System (PRS), as well as guidance on when you should continue to use the Classic PRS
• “Spotlight on SOPs” on the Standard Operating Procedure (SOP) entitled “Quality Management”, which provides best practice recommendations for conducting self-assessment monitoring of study documentation and processes
• “Dear IRB” on whether modifying subject compensation in exempt research requires an amendment to the IRB, as well as a broader discussion on when exempt amendments are needed

Learn more at www.bu.edu/crtimes.

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