When is the evaluation of a site's performance records typically conducted?

The evaluation of a site's performance records is typically conducted at the site initiation visit. This is an important phase because it allows the research team to assess whether the site is prepared to conduct the study according to the established protocols and regulatory requirements. During this visit, the team reviews the site’s capabilities, staff qualifications, and previous performance in clinical research, which helps to ensure they understand the sponsor's expectations and the specific study requirements.

This proactive assessment is crucial in identifying any potential issues before the actual study begins, thereby enhancing the likelihood of smooth operations later on. Evaluating performance records at this stage also facilitates any necessary training or adjustments to be made, which can directly impact the quality of data collected during the study. This foundational evaluation helps ensure compliance and integrity throughout the study process.