Presented by
Management Forum
A Practical Introduction to Good Clinical Practice (GCP) In-house Training
This highly interactive and practical one-day course will introduce you to both the principles of GCP and give you an understanding of how to practically apply it in different settings.
- Format: Live online
- CPD: 6 hours for your records
- Certificate of completion
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Course overview
This one-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.
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 researcher 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 course will introduce you both to the principles of GCP, and give you an understanding of how this applies in different settings.
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.
Benefits of attending
- Understand the importance of Good Clinical Practice (GCP) in clinical research studies
- Learn about how to apply GCPractice to real world settings
- Gain an opportunity to discuss GCP scenarios with experts with industry, academic and NHS experience.
- Participate in interactive sessions with other delegates, such as breakout rooms
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 delivery of introductory training slides
The role of institutional review boards in GCP
- Training slides supported with a role play of an Institutional Review Board (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
- Further training slides to support learning around informed consent
GCP and the protocol
- Breakout rooms assigned to sections of the protocol to discuss how GCP influences or is apparent in protocol design
- Training slides on protocol
- Activity linking protocol design day 1 topics (IRB, Informed Consent, Safety), supported with further training slides
Participant safety and wellbeing in the context of GCP, including: data safety, security and confidentiality
- Further training slides to review key areas such as date safety
- Scenario discussions to apply learning to real world setting
The importance of good documentation and the 'Attributable, Legible, Contemporaneous, Original, and Accurate' (ALCOA) principles
- Quiz on documentation supported by examples of common errors in documentation
- Training slides to introduce good documentation, ALCOA principles and highlight key learnings
Deviations, violations and serious breaches
- Training slides on GCP violations
- Break out rooms to discuss scenarios to apply learning to different perspectives (sponsor, site, CRO)
Who does what: roles and responsibilities in GCP
- Training 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
- Further training slides to provide additional examples in different settings
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.
Malta
- Orphalan Ltd.
Run A Practical Introduction to Good Clinical Practice (GCP) Live online for your team
2 days
Typical duration
Pricing from:
- GBP 1,000
- Per attendee, based on 10 attendees
- Course tailored to your requirements
- At your choice of location, or online
We can customise this course to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.
Contact our in-house training experts Aleksandra Beer and Yesim Nurko to discuss your requirements:
