The Need for Pretrial Audits in Clinical Trials — an Investigator's Perspective

Abstract

The advantages of and the need for performing pretrial audits as a prerequisite to the commencement of clinical trials in the FARMOVS Institute are discussed. The objective of the pretrial audit is to ensure that prior to starting the clinical trial all the necessary pretrial documentation and preparations have been completed to the standards required by both good clinical practice (GCP) guidelines and in-house standard operating procedures (SOPs). The execution of pretrial audits includes the scrutiny of the protocol, case record form (CRF), randomization schedule, ethics approval, informed consent, enrollment of subjects, safety data, trial medication, analytical procudures, apparatus, other disciplines involved, investigator's brochure and in-house SOPs. The main advantage of a pretrial audit is the timely identification of errors and problem areas, thereby ensuring maximum effectiveness during the execution of the trial.