Monitoring visits are an essential component of any clinical research project.  They help the sponsor and the Clinical Research Associate (CRA) confirm the integrity of the study data as well as ensuring the safety of the study subjects/participants.  During these visits the CRA will confirm if the study sites are following the protocol, ICH/GCP guidelines, regulatory requirements, and if the data collected is accurate and reliable.

In this article and episode of the "Let's Get Clinical" podcast, we will discuss the different types of monitoring visits that a CRA can perform during a clinical trial.

Pre-Study Visits (PSV) Explained:

Pre-Study Visits (PSVs) or Site Selection Visits (SSVs) are the first type of monitoring visit and are usually completed before the study begins. In addition to confirming the qualifications and experience of an investigator, a PSV/SSV is performed in order to assess the adequacy of a site (including assessment of facilities and equipment), potential pat...