What is required at a prestudy site visit?

A prestudy site visit is a critical step in the clinical trial process that involves assessing the adequacy of the research site to conduct the study effectively. The primary objective of this visit is to evaluate the site's capacity, which includes reviewing the resources available, such as staff qualifications, equipment, facilities, and the overall ability to meet the study requirements and ensure participant safety.

During this evaluation, the study sponsor or representative investigates whether the site has the necessary infrastructure, including access to potential participants, compliance with regulatory requirements, and the ability to maintain accurate and timely data. This comprehensive assessment helps to mitigate risks associated with conducting the trial at the site and ensure that it aligns with Good Clinical Practice (GCP) standards.

While training on the study protocol, reviewing informed consent forms, and inspecting investigational agents are undoubtedly important parts of the clinical trial process, they typically occur after the site has been deemed capable and ready to participate in the study. Hence, the evaluation of the site's capacity to conduct the study is the primary focus of the prestudy site visit.