@article{oai:kanazawa-u.repo.nii.ac.jp:00015279,
 author = {古川, 裕之 and 内潟, 将宏 and 松嶋, 由紀子 and 長田, 幸恵 and 横山, 英子 and 石崎, 純子 and 清水, 栄 and 神谷, 晃 and 宮本, 謙一},
 issue = {1},
 journal = {臨床薬理 = Japanese journal of clinical pharmacology},
 month = {Jan},
 note = {The major problem in the management of information on adverse events is found in both the clinical trial sponsor and the trial institution. The primary cause is inconsistency in the sponsors and trial institutions due to the use of original management methods which differ among sponsors or among trial institutions. In order to solve this problem, it is proposed to classify adverse events into three groups: "Case Report A", "Case Report B" and "Accumulated Information" based on the detected place (Japan or foreign country), the detected phase (clinical trial or post-marketing), unknown or known event, and the degree of severity. "Case Report A" and "Case Report B" will be evaluated individually, and "Accumulated Information" will be evaluated collectively in the institutional review board. Electronic list data is provided to the trial institution as the standard version only, and individual alteration request to the list data from institutions should not be accepted. Therefore, each institution should arrange the list data for creating its own database, if needed. The list data is presently provided by electronic media which are currently used widely such as the floppy disk or CD-R etc, but it might be necessary to plan for use by electronic mail. By classifying the adverse events and using electronic data for providing information about adverse events, more efficient information management is expected in both sponsors and trial institutions.},
 pages = {7--12},
 title = {臨床試験における有害事象情報の効果的な提供システムの構築},
 volume = {34},
 year = {2003}
}