Errors Identified by Early, Risk-adapted, Triggered On-site Monitoring in Physician-initiated Clinical Trials not for Regulatory Approval in Cardiovascular Diseases-Reference-Cited by-同舟云学术

Errors Identified by Early, Risk-adapted, Triggered On-site Monitoring in Physician-initiated Clinical Trials not for Regulatory Approval in Cardiovascular Diseases

Published:2023-01-31 Issue:1 Volume:54 Page:9-16
ISSN:0388-1601
Container-title:Rinsho yakuri/Japanese Journal of Clinical Pharmacology and Therapeutics
language:en
Short-container-title:Jpn. J. Clin. Pharmacol. Ther.

Author:

IKEHARA Yumi¹,MORIMOTO Takeshi²,IKEDA Masayuki³,NODE Koichi⁴,UEDA Shinichiro¹

Affiliation:

1. Department of Clinical Trials & Management, University of the Ryukyus Graduate School of Medicine, Okinawa, Japan

2. Department of Clinical Epidemiology, Hyogo Medical University, Hyogo, Japan

3. Department of Medical Informatics, Kagawa University School of Medicine, Kagawa, Japan

4. Department of Cardiology, Saga University of School of Medicine, Saga, Japan

Publisher

Japanese Society of Clinical Pharmacology and Therapeutics

Subject

Pharmacology (medical),Pharmacology

Link

https://www.jstage.jst.go.jp/article/jscpt/54/1/54_9/_pdf

Reference26 articles.

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2. Retracted article. Lancet. 2013; 382（9895）: 843. doi: 10.1016/S0140-6736（13）61847-4.

3. 2) Sawada T, Yamada H, Dahlöf B, Matsubara H; KYOTO HEART Study Group. Effects of valsartan on morbidity and mortality in uncontrolled hypertensive patients with high cardiovascular risks: KYOTO HEART Study. Eur Heart J, 2009; 30（20）: 2461‒9. doi: 10.1093/eurheartj/ehp363. Retracted article. Eur Heart J. 2013; 34（14）: 1023. doi: 10.1093/eurheartj/eht030.

4. 3) Ethical Guidelines for Medical and Biological Research Involving Human Subjects. ［https://www.meti.go.jp/press/2021/03/20220310006/20220310006-1.pdf （accessed 2022‒08‒26）］（in Japanese）

5. 4) Clinical Research Act. ［https://www.mhlw.go.jp/content/10800000/000524508.pdf （accessed 2022‒08‒26）］（in Japanese）