治験の品質向上を目的としたミーティングチェックリストの作成

Ariuchi, Kazuyo, 楊河, 宏章, Miyamoto, Toshiko, Imura, Mitsuko, Nishiya, Masako, Nakanishi, Rika, 苛原, 稔

In clinical trials, the emphasis is on following the study protocol and maintaining subject numbers. Numerous conditions are described in the protocol for each clinical study, and misunderstandings sometimes occur between the sponsor and investigators. At times, these differing interpretations of the protocol can result in study violations. The clinical research coordinator （CRC） plays a crucial role in the efficient progress of clinical trials by arranging close communication between the sponsor, participants, and investigators. In order to minimize misconceptions in study protocols, the CRC can be recruited to optimize communication between the sponsor and investigators. We have developed a checklist to ensure the clarification of protocol details before the beginning of clinical trials. The CRC used and modified the checklist during the mandatory introductory meetings for six trials that began in May and June of ２００４. Various points, such as concomitant medications, expense issues, and eligibility and exclusion criteria, were pointed out in the modification process. Further study is warranted to evaluate the benefit of the modified meeting checklist to minimize protocol violations in clinical trials.

治験の品質向上を目的としたミーティングチェックリストの作成

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