DB31/T 899-2015 Active Shanghai CityLocal standards

DB31/T 899-2015 Standards and operational guidance for ethical review of biomedical research involved human participants

DB31/T 899-2015 Standards and operational guidance for ethical review of biomedical research involved human participants

Publish Date: 2015-03-27 Implement Date: 2015-07-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: DB31/T 899-2015
Standard Type: Local standards
Standard Status: Active
is_force_gb: no
CCS Name: Medicine
ICS Name: Integrated medical science and healthcare devices
Publish Date: 2015-03-27
Implement Date: 2015-07-01
Pages: 48 pages

Scope

This standard stipulates the basic requirements that ethical committees of various institutions should meet during the review of biomedical research projects involving humans, the basic process of ethical review, types of ethical review, document management, and evaluation.
This standard applies to the ethical committees of institutions conducting biomedical research involving humans in Shanghai, including those established by medical institutions and scientific research universities.
This standard applies to the review of ethics in biomedical research involving humans in Shanghai.

Development Information

Word Count: 85 Thousand words Pages: 48 pages

Referenced Standards

药物临床试验质量管理规范(2003年) 国家食品药品监督管理局(SFDA) 涉及人的生物医学研究伦理审查办法(试行)(2007年) 卫生部(MOH) 药物临床试验伦理审查工作指导原则(2010年) 国家食品药品监督管理局

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