Attempt to improve quality control system of clinical trial data using electronic checklist

Increasing numbers of global studies in Japan are playing important roles in reducing the so-called "drug lag." The increase in number of clinical trials with complicated protocols, including the global studies, increases the workload on clinical research coordinators (CRC). Therefore, more efficient implementation of CRC tasks is necessary. In addition, improvements are required in quality control (QC) systems in institutions conducting clinical trials, including the employment of a local data manager (LDM). We have introduced a QC system in our institution using paper checklists usually provided by the sponsors of clinical trials. However, it is difficult to prevent the occurrence of human error. Therefore, we attempted to improve the QC system by switching from paper-based to electronic checklists (e-checklist) and supplementing the content confirmation process by staff via cloud computing. The e-checklist developed by our institution is a task management tool that does not require input of source data. The CRC can enter the e-checklist by iPad when working with a subject, and the data are immediately shared between related staff of our institution via Google Docs. The results of a questionnaire survey about the operability and usefulness of the e-checklist indicated a positive evaluation for operability on the iPad. We also found that content confirmation by other staff is useful to reduce errors when the CRC works with a subject. In conclusion, this QC system is useful for institutions conducting clinical trials, especially for those without an LDM.