Good Clinical Practice (GCP) Training and Certification

Good Clinical Practice (GCP) training is required for all individuals involved in the conduct of clinical trials in any of the following categories:

• Biomedical clinical trials submitted for initial IRB approval on or after November 1, 2016, with any source of funding or support; and
• Social-behavioral clinical trials that are submitted for initial approval on or after May 1, 2017, with any source of funding or support; and
• Clinical trials supported by the National Institutes of Health (NIH), with any submission date.

There are three options that satisfy the GCP initial training requirement:

• Completing the GCP Training through CITI (Collaborative Institutional Training Initiative) for Boston University Medical Campus/Boston Medical Center (available for both Biomedical and social-behavioral researchers).
• Attending one of two GCP-based courses offered by the Clinical Research Resources Office on or after January 1, 2014:
  • Fundamentals in the Conduct of Clinical Research: BMC and BU Medical Campus Research Professional Staff Training
  • The Principal Investigator Role: What Every New and Seasoned PI Needs to Know about the Conduct and Oversight of Clinical Research
• Completing other GCP training, if adequate documentation is provided to the IRB (medirb@bu.edu) regarding the topics covered and the individual’s completion of the course and the IRB Director considers the training to be acceptable.

Renewal of GCP Training:

GCP training must be renewed every 3 years through one of the following:

• Completing the CITI GCP “refresher module” that is available for those who have completed the initial CITI GCP training.  For those taking the GCP training module, the refresher course will auto-populate in the individual’s course menu 90 days before the training expiration date.  CITI will send reminder emails beginning 90 days before the GCP expiration in CITI.
• Completing any training that satisfies the initial GCP training requirement (including the Fundamentals or PI in-person training offered by the CRRO).
• For those who took in the past the Fundamentals or PI training offered by the CRRO which was counted towards their GCP Training, and now need to renew their GCP training (get a 3-year refresher option), they can:
  • Call CRRO to ask to take the CITI refresher (and the GCP refresher option will be made available), or
  • Take the Fundamentals or PI training again.