Effect of Drug Clinical Trials Information Systems in Quality Control Phase I Clinical Trial

OBJECTIVE To investigate the application of drug clinical trial information management system in quality control of phase I clinical trials. METHODS The drug clinical trial information management system was applied in the four Phase I clinical trials from August 2017 to August 2018. According to "the key points of onsite drug clinical trial inspection", the problems found in the original data verification and quality control were analyzed and it was compared with four phase I clinical trials of the traditional paper record management model. RESULTS Problems occurred in data integrity of subjects' screening/inclusion, data traceability of clinical trial inspection/assay, management and records of trial drug, and subject management were significantly lower after the use of the drug clinical trial information management system(χ²=11.922, P<0.001). CONCLUSION The application of drug clinical trial information management system in Phase I clinical trial projects guaranteed the integrity of the information, the standardization of drug management, the authenticity, integrity, credibility and traceability of clinical trials, and can improve the quality of Phase I clinical trials.