GCP for BionicalEmas 2023


Welcome to the resources page for the GCP Course.  Here you will find the course handouts and useful links.


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GCP Update Webinar Bionical 0923 HO

Video of Webinar

Useful Links


Nuremberg Code

Declaration of Helsinki


ICH E8(R1)

CTTI CtQ resource

Transcelerate ICH E8 Implementation resources


MHRA GCP forum – lots of useful information and examples

MHRA risk assessment examples

MHRA Inspection Metrics 2017-2018

MHRA Inspection Metrics 2018-2019

MHRA Inspection Metrics 2019-2020

MHRA Infringement Notice: Freelance monitor

MHRA Infringement notice: Investigator

MHRA Serious Breaches Guidance

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

MHRA Guidance on Access to Electronic Health Records

MHRA Guidance on oversight and monitoring of Clinical Trials

MHRA Guidance on Risk Adapted approaches to Clinical Trials

MHRA Guidance on responding to Inspection findings

HRA Page on combined approval in the UK

MHRA response to consultation on new legislation

Research Reset

O’Shaughnessy report


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 Clinical Trial Guidance Documents

FDA Guidance 1572

FDA Guidance Financial Disclosure

FDA Guidance Investigator Responsibilities

FDA Guidance IRB Waiver


MHRA guidance on RWD/RWE

FDA page on RWD/RWE

Draft FDA guidance on Demonstrating substantial evidence

ICH Reflection paper on RWD/RWE terminology

EMA page on Big Data

Data Analysis and Real World Interrogation Network (DARWIN EU)

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