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.

Sponsor monitoring- Clinical Trials

It is an important oversight process to ensure quality, compliance,and subject safety. Monitors may be employees of the sponsor’s medical staff or a contract research organization, or may be independent contractors. In each case, they represent the sponsor, and visit investigator sites regularly, perhaps every four to eight weeks. They examine subject records in detail and verify that the correct information was transferred to the clinical trial case report forms a process called source data verification. During their site visits, monitors also examine administrative and regulatory documents, including drug supply and dosing records, adverse events documentation and reporting, the informed consent process,and communications between the sponsor company and investigator and between the investigator and IRB. In short, the activities of clinical trial monitors are designed to ensure that all elements of the protocol are being followed. In addition, monitors examine the appropriateness of the qualifications, training, and training records of all site staff involved with the trial, and they communicate changes in site personnel to the sponsor company’s oversight team. Following the completion of a site monitoring visit, the monitor meets with the site staff to review findings and discuss (agree upon) corrections in data or improvements in processes, if needed. Monitors are expected to write a formal
monitoring report promptly after each visit. Reports are sent to the sponsor company’s medical department, which reviews the reports. When necessary, that department’s clinical research associates and physicians recommend remedial action. Regular monitoring ensures continued contact with an investigator site to keep
the sponsor company aware of the site’s safety and compliance status. Periodically, information from many monitoring visits and reports is gathered and analyzed for common problems. When problems are detected, special site- or trial-specific counseling and training is initiated.