Abstract
Good Clinical Practice (GCP) is an international standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials. The goal of GCP is to ensure the protection of the rights, integrity, and confidentiality of clinical trial participants and to ensure the credibility and accuracy of data and reported results. In the United States, trial sponsors generally require investigators to complete GCP training prior to participating in each clinical trial to foster GCP and as a method to meet regulatory expectations (ie, sponsor’s responsibility to select qualified investigators per 21 CFR 312.50 and 312.53(a) for drugs and biologics and 21 CFR 812.40 and 812.43(a) for medical devices). This training requirement is often extended to investigative site staff, as deemed relevant by the sponsor, institution, or investigator. Those who participate in multiple clinical trials are often required by sponsors to complete repeated GCP training, which is unnecessarily burdensome. The Clinical Trials Transformation Initiative convened a multidisciplinary project team involving partners from academia, industry, other researchers and research staff, and government to develop recommendations for streamlining current GCP training practices. Recommendations drafted by the project team, including the minimum key training elements, frequency, format, and evidence of training completion, were presented to a broad group of experts to foster discussion of the current issues and to seek consensus on proposed solutions.
Highlights
Good Clinical Practice (GCP) is the ethical and scientific standard for the conduct and reporting of clinical trials involving human participants
To ensure that results from clinical trials can support authorization of investigational products internationally, the principles of GCP have been adopted by regulatory authorities in Japan, the United States, and the European Union through the International Conference on Harmonisation (ICH) and implemented through the ICH GCP guideline E6.1,i These principles have been adopted by the International Standards Organization (ISO), an independent, nongovernmental membership organization made up of 163 member countries, through ISO-14155:201
In order to reduce these redundancies, the Clinical Trials Transformation Initiative (CTTI) aimed to develop recommendations regarding the key elements of GCP training as well as the optimal frequency for refresher training, format of training, and evidence of completion—which, if implemented, would conserve resources currently used to conduct repeated GCP training.[5,6]
Summary
Good Clinical Practice (GCP) is the ethical and scientific standard for the conduct and reporting of clinical trials involving human participants. Several regulatory agencies, including the United States Food and Drug Administration (FDA), expect clinical research personnel to have an understanding of GCP prior to engaging in clinical research. In order to reduce these redundancies, the Clinical Trials Transformation Initiative (CTTI) aimed to develop recommendations regarding the key elements of GCP training as well as the optimal frequency for refresher training, format of training, and evidence of completion—which, if implemented, would conserve resources currently used to conduct repeated GCP training.[5,6] Further, this would enable investigators and site staff to focus their attention on the safety of patients and the credibility and accuracy of data and reported results
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