A Questionnaire Study of the Clinical Trial Sponsor's View for the Activities in the Center for Clinical Trials of Hamamatsu University Hospital.

• YAMADA Hiroshi

  Center for Clinical Trials, Hamamatsu University School of Medicine

• ANEZAKI Ken

  Center for Clinical Trials, Hamamatsu University School of Medicine Department of Pharmacy, Hamamatsu University School of Medicine

• OHASHI Kyoichi

  Center for Clinical Trials, Hamamatsu University School of Medicine Department of Clinical Pharmacology & Therapeutics, Hamamatsu University School of Medicine

Bibliographic Information

Other Title

• 浜松医科大学附属病院治験管理センターの活動状況に対する治験依頼者へのアンケート調査

Abstract

We investigated the clinical trial sponsor's view for the activities of the center for clinical trials of Hamamastu University Hospital, under the revised good clinical practice (GCP) guidelines in Japan for the evaluation of its current supporting systems. Unsigned questionnaire-survey by mail was sent out between October 2001 and November 2001, to a total of 30 clinical trial sponsors. Twenty-five clinical trial sponsors including 28 responders replied to the questionnaire. Seventy-five percent of the responders had a favorable feeling towards receiving the monitoring or audit. Sixty-one percent were not satisfied with the activities of the clinical research coordinators, and wished to have assistance for recording the case report files or the participant's recruitment. For the contract, ninety-three percent had a feeling of abolition of repeated contract on each fiscal year and seventy-one percent were against advance payment. Both speedy and simple processes of contract making were also requested. University hospitals have a responsibility of promoting highly advanced medical services as clinical trials, therefore the solution of the problems presented by the clinical trial sponsors should be considered to achieve high quality and warranted clinical trials.

Journal

• Rinsho yakuri/Japanese Journal of Clinical Pharmacology and Therapeutics

  Rinsho yakuri/Japanese Journal of Clinical Pharmacology and Therapeutics 33 (4), 131-135, 2002

  The Japanese Society of Clinical Pharmacology and Therapeutics

Keywords

• clinical trials
• sponsor
• questionnaire
• good clinical practice (GCP)

Details

• CRID: 1390001205339434240
• NII Article ID: 10013250179
• NII Article ID: 120005305180
• NII Book ID: AN0025404X
• DOI: 10.3999/jscpt.33.4_131
• ISSN: 18828272
• ISSN: 03881601
• HANDLE: 10271/2174
• Web Site: https://hama-med.repo.nii.ac.jp/records/2135
• Web Site: https://search.jamas.or.jp/link/ui/2003032164
• Text Lang: ja
• Data Source:
  • JaLC
  • IRDB
  • Crossref
  • CiNii Articles
• Abstract License Flag: Disallowed