<b>Compensation, Insurance, and Management of Injuries in Investigator-Initiated Clinical Trials in Japan </b>-Reference-Cited by-同舟云学术

Compensation, Insurance, and Management of Injuries in Investigator-Initiated Clinical Trials in Japan

Published:2016 Issue:6 Volume:47 Page:219-228
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:

KURIHARA Chieko¹,HOSHI Junko²,SUZUKI Chieko³,SUZUKI Kazuko¹,KASAI Hiroi⁴,MORISHITA Noriko⁵,SATO Yayoi⁶,SUHARA Tetsuya¹,WATANABE Hiroshi⁷

Affiliation:

1. National Institute of Radiological Sciences, National Institute for Quantum and Radiological Science and Technology

2. Office of Planning Coordination Section, Pharmaceuticals and Medical Devices Agency

3. Center for Clinical Research, Hamamatsu University Hospital

4. Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital

5. Division of Clinical Research Promotion Institute for Clinical Research, National Hospital Organization Osaka National Hospital

6. Innovation Center for Clinical Research, National Center for Geriatrics and Gerontology

7. Department of Clinical Pharmacology and Therapeutics, Hamamatsu University School of Medicine

Publisher

Japanese Society of Clinical Pharmacology and Therapeutics

Subject

Pharmacology (medical),Pharmacology

Link

https://www.jstage.jst.go.jp/article/jscpt/47/6/47_219/_pdf

Reference11 articles.

1. 1) World Medical Association. Declaration of Helsinki: Ethical principles for medical research involving human subjects. Adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964, and last amended by the 64th WMA General Assembly, Fortaleza, Brazil, October 2013. [http://www.wma.net/en/30publications/10policies/b3/index.html (accessed 2015-12-25)]

2. 2) CIOMS (Council for International Organizations of Medical Sciences). International Ethical Guidelines for Biomedical Research Involving Human Subjects. 2002.

3. 3) International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). ICH Harmonised Tripartite Guideline: Guideline for Good Clinical Practice (ICH E6). 1996.

4. 4) Kurihara C, Kusuoka H, Ono S, Kakee N, Saito K, Takehara K, et al. High rate of awarding compensation for claims of injuries related to clinical trials by pharmaceutical companies in Japan: a questionnaire survey. PLoS One. 2014; 9(1): e84998. doi: 10.1371/journal.pone.0084998. eCollection 2014.

5. 5) Japanese Pharmaceutical Industry Legal & Business Affairs Association. Guidelines on compensation for injury resulting from participation in clinical trials. Legal Mind. 2009; Supplement 35: 6-20. (in Japanese)

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