Fundamentals of Clinical Research Document Management
These materials are set at Fundamentals level according to the NIHR CRN Training Plan (see Supporting Materials at the bottom of the page) and are here for you to work through as a self-directed learning package.
Although not exclusive, this piece of learning was originally created for staff who are:-
not required to complete GCP training by the Sponsor but need to support a team member who does
may have a GCP certificate but wish to re-engage with topic materials to help consolidate knowledge
You will need:-
to work through the materials from left to right & be prepared to answer questions at certain points.
to have reviewed the first document below.
for the second & third documents below - you need the named document for the study you are working on. Alternatively, there is a link to relevant NIHR templates to support you as you work through.
NB - A few questions would have been considered as a whole group - please still consider those questions as you may identify issues for you to discuss as a team.
If you wish to save evidence of learning, this is through self-reflection. We've provided a reflective account below for you to download and use.