Training in Good Clinical Practice (GCP) is designed to prepare research staff in the conduct of clinical trials. Completion of GCP training will demonstrate that individuals have attained the fundamental knowledge of clinical trial quality standards for designing, conducting, recording and reporting trials that involve human research participants. GCP training complements other required training on protections for human research participants.
Who is required to take this training?
Investigators and clinical trial staff who currently are or will be involved in the conduct, oversight or management of NIH-funded clinical trials. Definitions of “Investigator” and “clinical trial staff” for the purposes of this requirement are found in NIH NOT-OD-16-148.
Summary of the requirement
The principal investigator is expected to confirm at the time of award or progress report that all investigators and clinical trial site staff who are responsible for the conduct, management and oversight of NIH-funded clinical trials have completed training. Refresher courses in GCP topics are required every three years.
Courses that satisfy this requirement:
- The NIAID GCP Learning Center offers a free, 4-6 hour course.
- The NIDA Clinical Trials Network offers a free, 4-6 hour course
- The CITI Program offers two free, 4-6 hour courses:
- 4-6 hour course focused on clinical trials involving drugs and devices.
- 2-3 hour course focused on clinical trials involving behavioral interventions
HSD is willing to assess whether other training you have already completed meets the requirements.