The NIH GCP training policy is part of a multi-faceted NIH initiative to enhance the quality, relevance, feasibility, efficiency, and transparency of NIH funded clinical trials through stewardship reforms (see Hudson KL, Lauer MS, Collins, FS. Toward a New Era of Trust and Transparency in Clinical Trials. JAMA. 2016; 316(13):1353-1354). The principles of GCP help assure the safety, integrity, and quality of clinical trials. GCP provides a standard for ensuring clinical trial compliance, implementation, data collection, monitoring, and reporting (e.g., safety data, accrual reports, study status, protocol deviations, unanticipated problems, or final data), and outline the responsibilities of Institutional Review Boards (IRBs), investigators, sponsors and monitors. GCP addresses elements related to the design, conduct and reporting (e.g., safety data, accrual reports, study status, protocol deviations, unanticipated problems, or final data) of clinical trials. NIH applauds institutions that promote even higher standards by requiring their clinical trial investigators to surpass the baseline GCP standard.
Institutions need not regard the policy’s effective date as a deadline by which we would expect NIH-funded investigators and clinical trial staff involved in the design, conduct, oversight, or management of clinical trials to be GCP trained. Rather, as long as steps are being taken to meet the expectation, e.g., staff who have not yet been trained have signed up for a course, the training itself can be completed after the effective date.
The policy applies to NIH-funded clinical investigators and clinical trial staff who are responsible for the design, conduct, oversight, or management of clinical trials. The policy describes the investigator as the individual responsible for the design and conduct of the clinical trial at a trial site or, if a team of individuals at a trial site are involved, the investigator leading the team. The policy describes clinical trial staff as those who are responsible for study coordination, data collection, and data management. It provides examples of the activities such individuals may carry out such as participant recruitment and enrollment, including obtaining informed consent, data collection and documentation, and regulatory compliance and reporting. It notes that clinical trial staff may be referred to variously as a research coordinator, study coordinator, research nurse, study nurse or sub-investigator. 2 12-20-2016 The policy also applies to investigators and clinical trial staff: ? Whose clinical trials are exempt from the Common Rule (exempt categories defined in 45 CFR part 46.101(b)); ? Whose names are added on to non-competing progress reports; and, ? Who are on subawards, foreign awards, or foreign subcontracts. The policy does not apply to those who may consult with the clinical trial team but have no role in the design, conduct, oversight, or management of a clinical trial (e.g., a biostatistician acting as an independent consultant). Nonetheless, since consultants would likely also benefit from an understanding of GCP principles, they should not be discouraged from taking GCP training. In addition, if institutions find it easier to take a broader approach and apply the GCP policy to everyone on a covered protocol, they may do so.
The policy applies to investigators and staff involved in clinical trials. At the same time, however, understanding the principles of good clinical practice may be helpful to clinical researchers generally. The definition of clinical trial and guidance about it are available at http://osp.od.nih.gov/office-clinical-research-and-bioethics-policy/clinical-researchpolicy/clinical-trials.
The 2000 policy pertains to all research involving human subjects. Its goal is to ensure that investigators conducting such research understand the goals and principles of human subjects protections as well as the relevant regulations governing such research. The GCP policy applies to NIH-funded investigators and staff who are involved in the design, conduct, oversight, or management of clinical trials. Its goal is to ensure that NIH-funded clinical investigators understand ethical and scientific standards for clinical trial design, conduct, recording, and reporting.
The principles of ICH (E6) apply generally to all clinical trials. Some measures, e.g., reporting of adverse drug reactions to regulatory authorities, are pertinent specifically to trials of interventions involving drugs and devices, rather than to trials of behavioral interventions. However, the underlying principle of safety monitoring and reporting is relevant to all clinical 3 12-20-2016 trials and can be a guide to behavioral investigators in their monitoring and reporting of safety events to relevant oversight bodies, e.g., the Institutional Review Board.
The policy does not specify that a particular GCP course or program be taken. The policy includes links to GCP training courses sponsored by NIAID and NIDA (see, respectively, https://gcplearningcenter.niaid.nih.gov/Pages/default.aspx and https://gcp.nihtraining.com/about). In addition, NCATS has developed a GCP training program geared to behavioral clinical trial investigators (see https://obssr.od.nih.gov/training/web-based-learning/good-clinical-practice-forsocial-and-behavioral-research-elearning-course/). These courses are free of charge. Other free courses as well as fee-based courses are available.