CRAs responsibility is to make sure that sites are ready for any type of audit or inspection at any stage of the study.
A systematic and independent examination of trial-related activities and documents to determine whether the evaluated trial-related activities were conducted, and the data were recorded, analyzed, and accurately reported according to the protocol, sponsor’s standard operating procedures (SOPs), good clinical practice (GCP), and the applicable regulatory requirement(s).
The purpose of a sponsor’s audit, which is independent of and separate from routine monitoring or quality control functions, should be to evaluate trial conduct and compliance with the protocol, SOPs, GCP, and the applicable regulatory requirements.
During the audit, the trial will be discussed with the PI and other relevant clinical study personnel. The purpose of the interview is to figure out how clinical trial is managed at the specific site, to know how the procedures are supervised, determine the procedures for delegating study tasks by the PI. Also, it is important to know what is the experience of the clinical study team, while working on the particular study.
During the any type of audit and inspection CRA will provide full support to the site team, participating during site personnel interview with auditor if required, also translation of study documentations or source data.