Presented by
Management Forum
Introduction to Good Clinical Practice (GCP) In-house Training
This course will introduce you both to the principles of GCP, and give you an understanding of how this applies in different settings.
- Format: Live online
- CPD: 12 hours for your records
- Certificate of completion
Course overview
Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, recording and reporting trials that involve the participation of human subjects. GCP exists to both protect participants and ensure the integrity of data.
GCP training is an essential requirement for all researchers conducting Clinical Trials of Investigational Medicinal Product (CTIMPs) and is recommended learning for researchers involved in observational trials. There are different responsibilities of GCP depending on if you are the study sponsor, the Contract Research Organisation delegated to manage the study, or are working at the site.
This two-day introductory course gives attendees the opportunity to learn the basics of GCP, as well as understand how to apply GCP throughout the research lifecycle.
This course is part of our GxP training (Good x Practice) course collection, which features a variety of topic areas to ensure you comply with the most recent quality guidelines. For more information on the latest EU GMP regulations, see our GMP training course covering the Annex 1.
Benefits of attending
- Understand the importance of Good Clinical Practice in clinical research studies
- Learn about how to apply Good Clinical Practice to real world settings
- Gain an opportunity to discuss Good Clinical Practice scenarios with experts with industry, academic and NHS experience
Who should attend?
- Sponsor personnel responsible for trial design, sponsorship or ethical applications
- CRO personnel involved in regulatory processes, site set up, monitoring or close out activities
- Site personnel involved in regulatory processes, site set up, monitoring or close out activities
This course will cover:
Introduction to GCP, including the historical context
- Interactive opportunities to gauge current knowledge and deliver didactic training slides
The role of institutional review boards in GCP
- Didactic training slides supported with a role play of an IRB around a key GCP issue
Informed consent and GCP
- Instructor led example of poor informed consent with breakout rooms to dissect what we can learn from bad practice
- Didactic training slides to support learning
Participant safety and wellbeing in the context of GCP, including: data safety, security and confidentiality
- Return from break quiz on hot safety topics in GCP
- Didactic training slides to review key areas
- Scenario discussions to apply learning to real world setting
Deviations, violations and serious breaches
- Didactic training slides
- Break out rooms to discuss scenarios to apply learning to different perspectives (sponsor, site, CRO)
GCP and the protocol
- Breakout rooms assigned to sections of the protocol to discuss how GCP influences or is apparent in protocol design
- Didactic training slides
- Activity linking protocol design day 1 topics (IRB, Informed Consent, Safety), supported with didactic training slides
The importance of good documentation and the ALCOA principles
- Quiz on documentation supported by examples of common errors in documentation
- Didactic training slides to introduce principles and highlight key learnings
Who does what: roles and responsibilities in GCP
- Didactic slides to introduce key roles and responsibilities in a trial to align to GCP principles.
- Breakout rooms to create a roles and responsibilities matrix for a provided trial scenario.
- Didactic training slides to provide additional examples in different settings
Managing research misconduct
- Didactic training slides on topic
- Paired conversations on the soft skills needed for managing research misconduct (handling confrontation, difficult conversations)
Joe Milne
Scottish Brain Sciences
Joseph is a clinical trials specialist who has worked in laboratory and contract research organisations, and has led a clinical trials team for one of the world’s largest pharmaceutical companies. Joseph has a degree in Toxicology from Edinburgh Napier University and has been involved in research studies and clinical trials for over a decade. He is the Director of Clinical Research at Scottish Brain Sciences.
Sarah Gregory
Scottish Brain Sciences
Sarah is a postdoctoral researcher with a background in psychology, mental health and dementia clinical trials and large dementia prevention cohort studies. With experience of working in the NHS and academic institutions, she is particularly interested in Patient and Public Involvement work as well as ethical considerations of research, and is an active member of two research ethics committees. Sarah is the lead of a large cohort study at Scottish Brain Sciences and a research fellow at the University of Edinburgh.
