CRA Academy Graduate Creates a Regulatory Binder Template for a Clinical Trial Study Sponsor

A site’s Investigative Site File (ISF) is one of the first files that regulatory agencies look at during an audit. In this video, a CRA student reviews the contents of a typical ISF with a seasoned PI. Each ISF is different because of varying sponsor, CRO and study requirements yet each will typically contain similar sections which include but are not limited to IRBs, safety, training, drug accountability and recruitment.