TY - JOUR
T1 - The current situation and problems in clinical trials with electronic medical record system
AU - Ishiyama, Kaoru
AU - Sakurai, Machiko
AU - Kitagawa, Tomoko
AU - Nabata, Yuho
AU - Ono, Kyoko
AU - Masamichi, Shuji
AU - Koretsune, Yukihiro
AU - Kusuoka, Hideo
PY - 2007/9
Y1 - 2007/9
N2 - 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.
AB - 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.
KW - Clinical trial
KW - Electronic medical record system
KW - Source document verification
KW - Sponsor
UR - http://www.scopus.com/inward/record.url?scp=35748975990&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=35748975990&partnerID=8YFLogxK
U2 - 10.3999/jscpt.38.341
DO - 10.3999/jscpt.38.341
M3 - Review article
AN - SCOPUS:35748975990
SN - 0388-1601
VL - 38
SP - 341
EP - 348
JO - Japanese Journal of Clinical Pharmacology and Therapeutics
JF - Japanese Journal of Clinical Pharmacology and Therapeutics
IS - 5
ER -