GCP Part 2 for NuCana


Welcome to the course resources page for Part 2 of the GCP Course. If you were unable to attend the live session you can view the video in the Course Content section at the bottom of this page. Once you have viewed the video your certificate will be available to download.


Please take a moment to complete the feedback form below:

Course Handout

GCP Part 2 2021 ho

In answer to the question which was raised during the course regarding Information on GMP for N Ireland:
From what I can see the Northern Ireland protocol currently allows for a loophole in the QP release issue which means that you can import to and export from Northern Ireland under the either the UK or EU QP rules, so if your QP is in N Ireland you don’t need a re-certification in the EU. Whether this will remain the case is uncertain. Links to some relevant documents are below:

This document says: “For the export of IMPs from Great Britain to the EU, on the other hand, sponsors must organize a new importer and batch releaser, plus a new QP declaration. The only workaround for this is to have the IMP manufactured in Northern Ireland and then ship it to the EU, as it is then not considered an imported IMP under the Northern Ireland Protocol.”

EU Clinical Trials Regulation

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

EMA training on the Clinical Trials Regulation

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

HRA Page on combined approval in the UK

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

search previous next tag category expand menu location phone mail time cart zoom edit close