GCP Course for Lindus Health 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 For Lindus 0923 HO

GCP Webinar For Lindus 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

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