What is the purpose of a prestudy visit?

The purpose of a prestudy visit is to assess the site's readiness to conduct the study. During this visit, the study team evaluates whether the facilities, resources, and personnel are adequately prepared to meet the protocol requirements. This includes reviewing the physical infrastructure, equipment, and availability of necessary resources, as well as confirming that the site staff are sufficiently knowledgeable about the study procedures and requirements.

By ensuring that all elements are in place, the sponsor can minimize risks and maximize the likelihood of the study being conducted smoothly and effectively. This assessment is a critical step in the study initiation phase, as it helps to identify any potential issues that may arise before the study begins, allowing for timely adjustments.

While recruiting study participants, finalizing budget requirements, and training research staff are important aspects of a clinical study, these activities are typically addressed in separate phases of study preparation. Therefore, the focus of the prestudy visit is specifically on determining the overall readiness of the site to carry out the study.