Quality Management in Clinical Trials

Abstract

Clinical trials are conducted to collect the data necessary to provide information for academia, industry, and regulators to make decisions about the safety and efficacy of the disease, illness, or preventative medicines under study. To ensure investigators are following the protocol, complying with regulatory and Good Clinical Practice (GCP) standards, and collecting and reporting quality data, sponsors of clinical trials monitor the progress of clinical trials performed by the investigators during the clinical trial. The core components of monitoring are to ensure patient protection and to validate integrity of the data. Monitoring involves periodic on-site visits by monitors each year for the duration of a study as part of a quality process. Significant findings identified as a result of monitoring are escalated for review by the sponsor's Clinical Teams and Quality Assurance (QA) Departments, which may then be managed as a suspected significant deviation. Risk assessments and evaluations are then conducted. There are circumstances where decisions have to be made with regard to taking remedial actions, which may include notifying regulatory authorities and ethics committees of any significant regulatory and/or GCP requirements. At all times, the safety and rights of subjects are the top priority for the trial sponsor. Components for Quality Clinical research quality is designed and embedded in the clinical trial processes and study protocol well in advance of enrollment of the first patient. Components of the quality process related to clinical trial sites include: • Creating, implementing, and upholding standard operating procedures (SOPs) for trial execution • A quality scientific and medical design of the protocol • Clinical investigator and site pre-assessment and selection • Regulatory agency and ethics committee approval • Developing and providing appropriate informed consent (language, transparency of benefits and risks) and obtaining ethics committee approval of the informed consent process • Investigator meetings and training • Adequate recording and reporting of data • Periodic monitoring • Audits Appropriate planning before the trial, adequate oversight and monitoring during the trial, and verification to ensure accurate reporting of results at the conclusion of the trial, create a framework for assuring quality in clinical studies.