Page 112 - แนวปฏิบัติสากลว่าด้วยเรื่องธรรมาภิบาล

International Agency for research on Cancer (IARC), Common
minimum technical standards and protocols for biobanks

dedicated to cancer research, 2017. PDF
International Council for Harmonisation of Technical

Requirements for Pharmaceuticals for Human Use (ICH).
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*
International Organization for Standardization (ISO). ISO
20387:2018. Biotechnology – Biobanking – General

requirements for biobanking. Available from ISO website
International Society for Biological and Environmental

Repositories (ISBER), Best Practices: Recommendations
for Repositories, Fourth Edition 2018. Available from the

ISBR website U.S. Code of Federal Regulations, Title 21,
Part 11 (21.CFR.11). Available on the FDA website, content

current as of 7 June 2023.
U.S. Food and Drug Administration (FDA). Data Management

Plan. FDA Form 4070 (10/19). PDF
UNESCO International Bioethics Committee. Report on big

data and health. 2017. Available from the UNESDOC
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* The draft third revision of the ICH Harmonised Guideline on Good Clinical
Practice (GCP), E6(R3), was under public consultation at the time of
writing this document.

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