Requirements for who must take Good Clinical Practice (GCP) training just changed
NIH clinical trials: NIH-funded investigators and clinical trial staff who are currently involved in the conduct, oversight, or management of clinical trials must complete Good Clinical Practice (GCP) training prior to the first of the year, per an NIH policy released in September.
GCP training requirements can be met one of two ways:
- Completing the GCP training available at citiprogram.org. Yes, citiprogram.org is the same place you can access the required human subject protection (HSP) training. And no, GCP training does not take the place of the required HSP training; GCP training is done in addition to the HSP training.
- Send a record/certificate of current GCP training to Catrice Banks-Johnson at CRBanksjohnson@uams.edu.
GCP training is valid for 3 years.
Clinical trial staff is defined as: Individuals, identified by the investigator, who are responsible for study coordination, data collection and data management. The central focus of clinical trial staff is to manage participant recruitment and enrollment, to maintain consistent study implementation, data management, and to ensure integrity and compliance with regulatory and reporting requirements. These individuals may also seek informed consent from prospective participants, enroll and meet with research participants, and collect and record information from research participants. Clinical trial staff may also be called the research coordinator, study coordinator, research nurse, study nurse or sub-investigator.
Even if you are not currently involved in NIH-funded research, we strongly suggest that anyone who is a PI now and anyone who falls into the clinical staff definition go ahead and complete the training as soon as possible. That way, you’ll be ready to participate in NIH-funded research. Also, there is chatter in the regulatory world that GCP training is likely to be mandated more broadly within the next 6-12 months, as many institutions, journals, and other funding sources are trending toward this requirement.