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International Council for Harmonisation of Technical Requirements
for Pharmaceuticals for Human Use (ICH). Guideline for

*
Good Clinical Practice E6(R2). 2016. PDF
National Institutes of Health (NIH). Protocol templates for

Clinical Trials. Webpage, accessed 12 October 2023.
U.S. Department of Health and Human Services (DHHS).

Guidance Portal. Clinical trials eprotocol/template tool.
HHS-0925-2018-F-8086, issued 11 January 2018. Available

from the DHHS website
U.S. Food and Drug Administration (FDA). Understanding

Sex Differences at FDA. Webpage, content current as of
04/12/2019.

World Medical Association. WMA Declaration of Helsinki –
ethical principles for medical research involving human

subjects. 2013. Available on the WMA website
World Medical Association. WMA Declaration of Taipei on

ethical considerations regarding health databases and
biobanks. 2016. Available on the WMA website

* 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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