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Hindi Review Article
AUDIT OF AN INVESTIGATOR SITE - A CRUCIAL TASK IN CLINICAL RESEARCH TO ENSURE A RELIABLE CLINICAL TRIAL: REVIEW OF PLANNING, METHODOLOGY AND TECHNIQUES
Abstract
Clinical trials for establishing the safety and efficacy of a drug can be among the most costly and time-consuming elements of product development. The success of any clinical trial is dependent on assuring that the data collected are of good quality. Clinical investigator site audits may be conducted at any medical facility or institution where clinical trials are conducted on human volunteers or subjects. Due to the increasing complexity of clinical trials and regulatory scrutiny, the components of a site audit program and the approaches taken towards designing and managing audits are constantly evolving. Audit forms an important part of a quality system to determine if clinical studies are being conducted in compliance with applicable statutory and regulatory requirements paying particular attention to subject rights, safety and well-being, and to provide verification of data integrity. Although auditing alone cannot transform a poorly planned, executed, monitored, or analyzed trial into a credible one, an active clinical trial audit program will point out potential problem areas early, so solutions can be found before it is too late. Used effectively investigator site audits can reduce costs, maintain project schedules, and ensure regulatory compliance. To make sure that these benefits will be realized, however, sponsors must develop a comprehensive auditing strategy.
