The sponsor “is responsible for implementing and maintaining quality assurance and quality control systems with written standard operating procedures to ensure that trials are conducted and data generated, documented, and reported in compliance with the protocol, good clinical practices, and the applicable regulatory requirements.” To accomplish this, institutions must have quality assurance programs to assure that each participating investigator is fulfilling his/her responsibilities. Quality assurance provides institutes with data about the quality of execution of their clinical research, and it provides investigators an opportunity to learn through external evaluation. The Clinical Research Group ensures that clinical trials are monitored adequately and centrally. The Clinical Research Group also determines the appropriate extent and nature of monitoring based on considerations of the study objectives.