Abstract:Objective To analyze the reasons for data questioning generated by clinical research coordinators (CRCs) entering electronic medical record report forms in phase Ⅰ clinical trials. Methods The phase Ⅰ clinical trial projects of 3 innovative drugs that have completed electronic data entry from 2019 to 2022 in the Phase Ⅰ Clinical Research Laboratory of Huashan Hospital, Fudan University were selected. Electronic data questioning report was provided by the sponsor's data management department. The distribution of data questioning in different stages and modules of the trials were analyzed, and the types of errors were classified and statistically analyzed, and corresponding countermeasures were put forward for continuous improvement. Results (1) Data questioning in the process of clinical trials were most likely to occur in the follow-up period, accounting for 66.78%. (2) The system automatically triggered type of questioning accounts for the highest percentage, and the manual logic verification type of questioning had the most analytical significance. (3) In the manual logic verification type of questioning, the occurrence rate of textual errors was the highest (47.53%), followed by logic errors and page-related errors. The three modules with the highest incidence were laboratory tests (41.25%), vital signs/electrocardiogram (14.64%), and adverse events/combined medications (9.36%). (4) Lack of responsibility and weak professionalism on the part of CRCs were the most significant factors that led to questioning. Conclusion During the process of data entry, it is necessary to focus on improving the sense of responsibility of CRC, strengthening their training on the use of informatization system and professional knowledge, ensuring the truthfulness and completeness of trial data, and reducing the incidence of data entry errors.