Clinical Research Times

November 10, 2026

Dear Colleague:

This month’s Feature Article describes the recent change that allows IRB review and ancillary routing review to run concurrently, including what does and does not change, and how to check the status of your sign-offs in INSPIR.

Also check out:

• “Things to Know”
  • On the activation of cross-hospital research for BMC Health System researchers, including manual chart review, primary data collection, and recruitment at hospitals beyond their home institution; the approvals required before those activities begin; and the data access restrictions that remain in place
  • On the two new INSPIR questions that capture cross-hospital BMCHS recruitment and data access
  • On the IRB Global Reliance Agreements now in effect between the BMC/BUMC IRB and the Boston University Charles River Campus (CRC) IRB, which streamline multisite collaborative research
• “Getting to Know ClinicalTrials.gov” for the latest updates on the Protocol Registration and Results System (PRS) modernization, including the timeline for phasing out the Classic PRS
•  “The CRRO Corner” on utilizing the CRRO Study Documentation Templates library, which include 24 customizable templates and guidance for study tracking and data collection, plus regulatory binder resources
• “Dear IRB” for guidance on whether a project that meets the HRPP Policy criteria for Quality Improvement (QI) needs to be submitted to the IRB

Learn more at www.bu.edu/crtimes.

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