Welcome!
Welcome to the resources page for the GCP Course. Here you will find the course handouts and useful links.
Feedback
Please take a moment to complete the feedback form below:
Handout
GCP Update Webinar Bionical 0923 HO
Video of Webinar
Useful Links
International
Transcelerate ICH E8 Implementation resources
UK
MHRA GCP forum – lots of useful information and 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 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
US
FDA Clinical Trial Guidance Documents
FDA Guidance Financial Disclosure
FDA Guidance Investigator Responsibilities
RWD/RWE
Draft FDA guidance on Demonstrating substantial evidence
ICH Reflection paper on RWD/RWE terminology
Data Analysis and Real World Interrogation Network (DARWIN EU)