Abstract
To clarify the current situation and problems in clinical trials with the electronic medical record system (EMR), a survey of 183 hospitals and 45 sponsors was undertaken. Among them, 133 hospitals replied and 31 are using EMR. More than 60% fulfilled “the check items to secure the reliability of clinical trial data in medical institutions using EMR systems” issued by the Japan Pharmaceutical Manufacturers Association. However, several problems have been revealed. It is necessary to clarify either paper-based data or electric data as source documents and to stipulate it in standard operating procedure since both of them are often used together. The identification and authentication of monitors, partition of patient's information, and controlling the access rights at source document verification (SDV) are not properly conducted in all hospitals. Also 35 replies were obtained from the sponsors, and they are generally favorable to EMR because EMR can improve the reliability of data. In conclusion, currently few hospitals perform clinical trials with EMR, and it is necessary to solve several problems, especially relating SDV with EMR.
