Introduction to Clinical Trials and GCP – MicroPharm

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Welcome to the resources page for the Introduction to Clinical Trials and GCP Courses.  Here you will find the course handouts and useful links.

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Handout

Intro to CR and GCP Micropharm 2024 HO

Useful Links

International

Nuremberg Code

Declaration of Helsinki

ICH GCP (R2)

ICH E8(R1)

UK

MHRA GCP forum – lots of useful information and examples

MHRA risk assessment examples

MHRA Inspection Metrics 2019-2020

UK SI 2004 1031 – Medicines for Human Use (Clinical Trials) Regulations

UK SI 2006 1928 – Medicines for Human Use (Clinical Trials) Amendment Regulations

MHRA Guidance Page for GCP

HRA Page on combined approval in the UK

MHRA response to consultation on new legislation

ICO guidance on GDPR in the UK

ABPI guidance on First in Human Studies

Research Reset

O’Shaughnessy report

Kenya

Pharmacy and Poisons Board rules June 2022

https://web.pharmacyboardkenya.org/download/ppb-rules-june-2022/

Clinical Trials Guidance documents for Kenya

https://web.pharmacyboardkenya.org/clinical-trials/

and

https://web.pharmacyboardkenya.org/download/guidelines-for-the-conduct-of-clinical-trials-in-kenya/

NIH information on Clinical Trials Regulation in Kenya

https://clinregs.niaid.nih.gov/country/kenya#regulatory_authority

Australia

New clinical trials website

https://www.australianclinicaltrials.gov.au

New national statement on Research Ethics

https://www.nhmrc.gov.au/about-us/publications/national-statement-ethical-conduct-human-research-2023

Australian Clinical Trials Handbook

https://www.tga.gov.au/resources/resource/guidance/australian-clinical-trial-handbook

US

FDA 21 CFR part 11

FDA 21 CFR part 50

FDA 21 CFR part 54

FDA 21 CFR part 56

FDA 21 CFR part 312

FDA Newly Added Guidance Documents

FDA page on RWD/RWE

FDA Guidance 1572

FDA Guidance Financial Disclosure

FDA Guidance Investigator Responsibilities

FDA Guidance IRB Waiver