Written by Jo Nugent, Online Communications Officer, Greater Manchester CLRN
I started working for GM CLRN in March 2011 and as part of my training I’ve recently completed a Good Clinical Practice (GCP) training course.
The course was delivered by Julia O’Toole, Senior Manager,Greater Manchester Comprehensive Local Research Network (GM CLRN) and is aimed at GPs, practice nurses, healthcare assistants and admin personnel who will be working in the clinical research area.
The course outlined the principles and key components of GCP, as well as the regulations and the responsibilities of the different people and organisations involved in research.
As I’m new to research, I found the course was really good at giving me a background to the field as well as providing valuable information on:
- Why research is important and lessons learned from past experiences
- Responsibilities of the Sponsor, Investigator and Care Organisations
- Consent – who can take consent, what this means and how to obtain consent
- Trials – provides background information, description of objectives and details about the different phases of research.
- Phase 1 – The experimental drug or treatment is given to a small group of healthy volunteers (20-80) to evaluate its safety, determine a safe dosage range and identify side effects
- Phase 2 – a larger group of participants (100-300) trial the experimental drug or treatment to see if it is effective and to further evaluate its safety
- Phase 3 – large groups of participants (1,000-3,000) trial the experimental drug or treatment to confirm its effectiveness, monitor side effects, compare it to commonly used treatments and collect information that will allow the experimental drug or treatment to be used safely
- Phase 4 – this phase involves post marketing studies to delineate additional information including the drug’s risks, benefits and optimal use
- Safety – talks about Adverse Events (AE), Serious Adverse Events (SAE) and Suspected Unexpected Serious Adverse Reaction (SUSAR) and how they should be reported
- Documentation – outlines responsibilities of keeping the Trial Master File (TMF) up to date, importance of storage and archiving
- Audit – Accurate and complete records that are legible and data should be consistent with source documentation and made available for inspection
GM CLRN organises a number of GCP training events for all levels of people who are involved in research. If you would like to attend GCP training or for more information please email the GM CLRN Training team