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Clinical Research Times

May 31, 2022

Dear Colleague:

An effective Corrective and Preventive Action (CAPA) plan helps to protect the rights, safety and welfare of study subjects, and the reliability of the data. This month’s Feature Article includes the release of an updated Corrective and Preventive Action (CAPA) Plan template to be used effective immediately; and provides background about CAPA plans, examples of inadequate corrective actions, and the steps necessary for developing a strong CAPA plan.

Also check out:

  • “Things to Know”
    • On a new requirement for Principal Investigators (PIs) to sign off on the submission of Reportable Event and New Information (RENI) forms
    • On collection of information about the targeting of BMC inpatients and/or outpatients in the INSPIR application
    • On recent changes to INSPIR for studies that involve inpatient and/or outpatient nursing staff, including a new question in the cede application
    • On the upcoming IRB Office drop-in hours for June 2022
  • “Getting to Know ClinicalTrials.gov” for tips on submitting results and documents on ClinicalTrials.gov, and what can be done to make that process more efficient
  • “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 AY 2021/2022
  • “Dear IRB” for guidance on when the BMC/BU Medical Campus IRB requires local IRB review, versus when you are permitted to cede to an external IRB

Learn more at www.bu.edu/crtimes.

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