治験コーディネーターから見た日本とオーストラリアにおける薬物臨床試験の実施状況の比較 : 荏原病院とQ-Pharmを中心に

概要

論文の詳細を見る
原著論文A comparison was made on the conduct of clinical trial at the Tokyo Metropolitan Health and Medical Treatment Ebara Hospital in Japan and Q-Pharm Pty Limited in Australia. The followings were pointed out as the differences of role and responsibility between CRC of Ebara Hospital and SC of Q-Pharm.. 1) The SC of Q-Pharm is actively involved in managing clinical study itself, such as organizing study team members. The attitude of CRCs of Ebara Hospital is inclined to assist investigator rather than manage. The CRCs also make considerable effort in coordinating functions in the hospital andare involved in the study. 2) The coverage of CRC at Ebara Hospital is wider than that of SC of Q-Pharm. The tasks of CRC extend from contacting to sponsor before the contract is signed, complementary explanation of the study to recruited study subjects, participation to study audit. The main tasks of SC start from initiation of a study. The SC does not get involved in obtaining the informed consent from study subjects. 3) The role and responsibility of SC of Q-Pharm is described in the job description, whereas, no job description is available for CRC of Ebara Hospital. 4) It is presumed that the clarification of the job of CRC in Japanese study sites will lead to the improvement of efficiency of clinical study conduct.