Regarding the working hours generated by clinical trial project services under the guidance of good clinical practice (GCP), taking the standard process of a cancer project screening period as an example, and relying on a standardized management model, this paper uses standard time measurement methods to calculate the standard time of the 12 regular tasks in the GCP project. On this basis, it analyzes the GCP project process in detail to find out the reasons for wasted performance hours, and proposes a series of improvement methods and suggestions, such as formulating and implementing a target assessment mechanism, developing standard format cards, using double-line operations research to carry out parallel operations, using quadrant method to divide tasks, using site management organization and resources of hospital departments to reduce coordination loss, and introducing big data management systems, so as to make the work process of clinical research coordinators more refined and professional.
Establishing and improving the quality control system of drug clinical trial institutions is the key to ensure the quality of clinical trial. In recent years, the number of drug clinical trial has been continuously improved, and the quality control requirements have been continuously improved. However, in clinical work, the workload of medical staff is heavy, and the energy devoted to clinical trial is limited. Clinical research coordinator (CRC), as a participant and coordinator of clinical trial, has carried out transactional work related to non-medical judgment under the authorization and guidance of researchers, and has undertaken any specific work in clinical trial. Based on the quality control management experience of nosocomial CRC and hospital drug clinical trial institutions in West China Hospital of Sichuan University, this paper discusses the mode of nosocomial CRC participating in clinical trial quality control. By participating in the quality control of clinical trial, the nosocomial CRC has improved the quality control efficiency, enriched the quality control team and improved the overall level of CRC. This model enriches the quality control system of drug clinical trial.
