Clinical Research Times

February 22, 2023

Dear Colleague:

The IRB strives to continuously update the INSPIR application and IRB templates to prevent mistakes or misinterpretations; however, some common errors persist. To help prevent you from making these errors, and thus facilitate an efficient IRB review process, this month’s Feature Article will highlight the sections of the application that lead to the most common stipulations.

Also check out:

• “Things to Know”
  • On recent updates to BMC’s consulting policy, including the new requirement to submit the BMC Consulting Checklist
  • On an opportunity to work in the BMC/BUMC IRB office
• “Getting to Know ClinicalTrials.gov” on understanding the outcome measures section in ClinicalTrials.gov (Part II)
• “The CRRO Corner” on the 2023 training calendar
• “Spotlight on SOPs” on the Standard Operating Procedure (SOP) entitled “Institutional Clinical Research Policies and Guidance Library”, which discusses what the SOPs are, what is available within the SOP library, and additionally provides a number of other useful institutional resources
• “Dear IRB” for guidance on making modifications to key study personnel while the submission is still awaiting routing sign-offs or IRB review

Learn more at www.bu.edu/crtimes.

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