A systematic and independent examination of trial related activities and documents to determine whether the evaluated trial related activites were conducted, and the data recorded, analyzed, and accuratedly reported according to ther procol, sponsor's standard operating procedures, GCP, and the applicable regulator requirement(s).
A declaration of confirmation by the auditor that an audit has taken place.
A written evaluation by the sponsor's auditor of the results of the audit.
Documentation that allows reconstruction of the course of events.
A procedure in which one or more parties to the trial are kept unaware of the treatment assignments.
Usually refers to the subjects being unaware of their treatment assignment.
Usually refers to the subject's investigators, monitors, and in some cases data analysts being unaware of the treatment assignment.
Case Report Form
A printed, optical, or electronic document designed to record all of the protocol required information to be reported to the sponsor on each trial subject.