NIH leadership released a new policy requiring GCP training as of January 1, 2017 (see: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-148.html).
There are three important components of this policy that may require some research teams to take additional GCP training:
- The policy extends to all clinical trials including behavioral interventions.
- The entire research team ((Principal Investigator (PI) and all clinical trial staff)) must complete the training. The training must be updated every three years.
- While the new JHM policy only applies to individuals conducting clinical trials, GCP training is relevant to all types of clinical research and will count as a component toward the more general Human Subjects Research Training recertification requirements.
Over the past few years, clinical research leaders have expressed the benefits of GCP training for those wishing to conduct high quality clinical trials. As clinical trials have increasingly become multicenter, the need for common training has become apparent. Many NIH clinical trial groups already require GCP training, as do some corporate sponsors. To avoid confusion, our Johns Hopkins Medicine policy will require up-to-date GCP training for the entire research team, including staff, on all clinical trial protocols no matter who is funding the research. There are "trials" that would not qualify as more than minimal risk that would still require adherence to the NIH policy.
GCP FAQ’s
What Is Good Clinical Practice (GCP)?
A standard for the design, conduct, performance, monitoring, auditing, recording, analyzing and reporting of clinical trials. Compliance with GCP provides assurance that the study data are credible and accurate and that the rights, safety, confidentiality and well-being of research participants are protected.
What is a Clinical Trial?
A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.
Who is Principal Investigator?
The individual responsible for the conduct of the clinical trial at a trial site.
Who are Clinical Trial Staff?
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, data analysis, 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 the 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.
What is accepted as GCP training?
Principal Investigators and research teams who are subject to this new policy can meet the training requirement by completing the CITI GCP training course. Other GCP training will be accepted as meeting the requirement if the course is approved by TransCelerate. The JHM IRB now offers certified GCP training, which satisfies the NIH training requirement. http://lms14.learnshare.com/l.aspx?CID=89&A=2&T=339728
How does someone best access GCP training?
- Johns Hopkins OHSR Compliance Monitoring Program monthly seminar: GCP Fundamentals: Understanding and Applying GCP to Human Subjects Research (In-person course) http://lms14.learnshare.com/l.aspx?CID=89&A=2&T=339728
- CITI GCP training course (http://lms14.learnshare.com/l.aspx?CID=89&A=2&T=521555)
- The NIAID GCP Learning Center website (http://gcplearningcenter.niaid.nih.gov)
- National Drug Abuse Treatment Clinical Trials Network (https://gcp.nihtraining.com/)
How does someone indicate to the IRB that they have taken GCP training?
A question will be added to the eIRB application requiring Principal Investigators to certify that they, and all members of the study team, have completed the required GCP training. PIs will be required to answer this question as part of all new applications and new change in research applications submitted after the next eIRB update. Random audits for certificates of completion will begin in the spring of 2017. If GCP training is taken other than through CITI, individuals must print the certificate of completion and keep it on file.
If I have already completed GCP training, how do I know that it is Transcelerate-approved?
http://www.transceleratebiopharmainc.com/gcp-training-attestation/#headline4
How do I identify in my NIH grant application (PHS 398) the personnel that must complete GCP training?
Review your NIH application’s sections entitled, “SENIOR/KEY PERSONNEL” and “OTHER SIGNIFICANT CONTRIBUTORS.” The individuals that you have listed are required to complete TransCelerate certified GCP training. Minimally, all research personnel that have submitted a biosketch are required to complete GCP training.
How should I document that all study team members have completed required GCP training?
As a part of your regulatory file, consider developing a training log that lists the names of all study team members on the project, and includes dates indicating the completion of required training (including GCP). For monitoring purposes and to confirm compliance with institutional and NIH requirements, it is also advised that the certificates of GCP training completion be maintained in the regulatory file.
Questions related to GCP training should be sent to gcpcompliance@jhmi.edu.