In 2016, the National Institutes of Health (NIH) issued a policy establishing an expectation that all NIH-funded investigators and staff involved in conducting, overseeing, or managing clinical trials should be trained in Good Clinical Practice (GCP) and should refresh their training at least every three years. The purpose of GCP is to ensure the safety, integrity, and quality of clinical trials. GCP provides a standard for compliance, implementation, data collection, monitoring, and reporting, and outlines the responsibilities of Institutional Review Boards (IRB), investigators, sponsors, and monitors.

Researchers will recognize familiar principles in this training, such as ensuring that study participants are fully informed before giving consent and collaborating with IRBs to monitor any adverse events. GCP also highlights principles related to study operations, like adhering to detailed protocols and quality management plans. Although these activities are sometimes seen as extra “paperwork,” GCP underscores their importance in maintaining the rigor, transparency, and ethics of study conduct.

The principles explored in the GCP training are essential to thorough and ethical behavioral and social sciences research. GCP helps investigators and clinical trial staff protect the rights, safety, and well-being of human subjects, ensure that their clinical trials are conducted according to approved plans with rigor and integrity, and that the data collected is reliable.

In 2016 and 2017, OBSSR partnered with the National Center for Advancing Translational Sciences (NCATS) and the Society of Behavioral Medicine (SBM) to develop a GCP training specifically for behavioral and social sciences research. With the recent changes to the NIH definition of clinical trials, more researchers in these fields are now conducting clinical trials. As a result, keeping the course updated with the latest best practices, especially as they relate to trials in the behavioral and social sciences, is more important and relevant than ever.

In 2024, NIH released an updated version of the GCP for Social and Behavioral Research eLearning Course. In addition to updating the accessibility of the training, the course now includes new content relevant to community and partner engagement. The updated training can be accessed free of charge and we encourage researchers to use this tool.