GCP Update Webinar – Monday 11 April 2022

 

 

Welcome!

Welcome to the course resources page for the GCP Update course. If you need a certificate for this course please view the video and then open the lesson at the bottom of this page to confirm your completion of the course. You will then be able to download your certificate.

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Course Video

Course Handout

GCP Update 0422 ho

Useful Links

EU Clinical Trials Regulation

Eudralex Vol 10 – here you can find all the legislation and guidance for Clinical Trials in the EU

EMA page on the Clinical Trials Information System

ICH GCP (R2)

ICH E8(R1)

MHRA Inspection Metrics 2018-2019

MHRA Guidance on Access to Electronic Health Records

HRA Page on combined approval in the UK

Q&A on Reference Safety Information

FDA Clinical Trial Guidance Documents

BIMO Inspection Report 2021

Transcelerate Risk Based Monitoring Page – lots of information and tools

COVID-19

MHRA Guidance: https://mhrainspectorate.blog.gov.uk/2020/03/12/advice-for-management-of-clinical-trials-in-relation-to-coronavirus/

AND: https://www.gov.uk/guidance/managing-clinical-trials-during-coronavirus-covid-19

HRA Guidance: https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/covid-19-guidance-sponsors-sites-and-researchers/

EMA Guidance: https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-10/guidanceclinicaltrials_covid19_en.pdf

AND:

https://www.ema.europa.eu/en/documents/scientific-guideline/points-consider-implications-coronavirus-disease-covid-19-methodological-aspects-ongoing-clinical_en-0.pdf

FDA Guidance: https://www.fda.gov/media/136238/download