GCP Courses
We offer several courses in Good Clinical Practice (GCP). For full details, availability and to register for a course please go to our Glasgow Clinical Research Facility Education Unit Website
Course Details
Introduction to Good Clinical Practice (GCP)
This full day course is appropriate for all staff who are involved in any context with clinical research, in particular for those conducting a Clinical Trial for an Investigational Medicinal Product it is a regulatory requirement.
Topics include:
- History of Clinical Trials and the development of GCP
- Deciding what is a clinical trial
- Informed consent
- Responsibility of Research Personnel
- Pharmacovigilance
- Monitoring
This session is relevant to individuals who have no previous GCP training
Good Clinical Practice (GCP) Refresher Course
These sessions are appropriate for all staff who are involved in any context with clinical research, in particular for those conducting a Clinical Trial of an Investigational Medicinal Product it is a regulatory requirement.
Topics include:
- Regulation Amendments
- MHRA Inspections
- Pharmacovigilance
- Standard Operating Procedures
- Trials master files
- Clinical Trials in Glasgow
This session is relevant to individuals who have had previous GCP training.
Pharmacovigilance for CTIMP's
This workshop is intended for research personnel involved in clinical trials of investigational medicinal products (CTIMPs) sponsored by NHSGGC.
It is particularly relevant to those who are responsible for recording, assessing, or reporting drug related safety issues.
AIM
The aim of the workshop is to equip attendees with the knowledge and skills they require to fulfil their responsibilities in safety reporting.
OBJECTIVES
On completion of the workshop attendees will:
- Define the terms used in Pharmacovigilance
- Know who is responsible for safety reporting
- Identify and assess medical events for seriousness, causality and expectedness
- Apply the process for safety reporting in CTIMPs sponsored by NHS GGC
