Quality Assurance

Each pharmaceutical sponsor company should have a quality assurance unit that is independent of the operational area that is, outside the company’s clinical research group. The function of the QA unit is to conduct independent assessments and audits to ensure that appropriate clinical research processes are in place and that clinical operations are being conducted according to relevant regulations and guidelines, and in conformance with the sponsor’s corporate policies, procedures, and trial protocol. QA is to report any variations or deviations it finds to the operational area staff and management and, periodically, to the company’s senior management.

Although organizationally separate from the clinical research component, QA personnel work closely with clinical operations to understand its internal processes and activities and to learn the locations of trial sites and site-related activities. It is important for the QA department to know “where the action is,” and to be there frequently enough to ensure that things are done properly. This means compiling a list of clinical operations group activities and conducting a formal or informal risk assessment to determine which processes and areas are best under control. Examples of risk factors are investigators new to clinical research who require further
training and sites with high staff turnover, which can lead to uncertainties and mistakes in clinical trial practice. QA personnel can then conduct planned audits of sites and medical processes and write reports for QA management review. The management and staff of the audited group receive final reports of the audit
findings, as do designated senior managers throughout the company.

In some cases, “special alert” notations may be marked on audits to trigger specific and prompt action by senior corporate managers. In fact, all audit findings require some response, such as who will address the issue, what the action plans are, and when they will be completed. The QA department tracks the action plans to completion with the goal of continual improvement in quality, compliance, and safety reporting.