GCP Essentials in 90 minutes – eLearning
Book a session
| Date | Product | Location | Price | |
|---|---|---|---|---|
| GCP Essentials in 90 minutes | eLearning | EUR 175.00 | Book | |
| If you would like to have this course as an in-house session click here | ||||
About this course
Reasons to attend
This GCP online training is for all those who need to grasp the essence, but not all the details of the Good Clinical Practice (GCP) guideline. In 90 minutes, essentials of GCP and inspectors expectations are presented for a basic, but sound GCP-mindset.What's included?
- Documents and materials related to this course are included
- Globally recognised certificates awarded after test completion
- This course has been reviewed by the Belgian GCP Inspectorate.
Course schedule
- Course credit: 1.5h (3 months period to complete course)
- Complete the course at anytime, anywhere!
Course Description
If you need to acquire a basic but solid GCP- mindset, without going into too much detail, this GCP online training is for you. In a mere 90 minutes, GCP is presented without leaving out any important elements: starting with the reason that GCP exists, its definition, its main elements, and what it entails for the parties involved during clinical trials. For completeness, the connection with legislative obligations is also covered.Furthermore, what GCP- inspectors are looking for, what is their approach and examples of non-compliance are included. In short, the course covers all information one needs for GCP- wise thinking.Programme highlight
- Reasons for Good Clinical Practice
- GCP’s key elements: ethics, science, quality, traceable data & documents
- GCP requirements for Ethics Committees, for Sponsors, for Investigators
- “GCP in practice”: implementation during clinical investigations, from start to finish
- Thinking like a GCP-inspector: legislative ground, procedures and findings
Learning objectives
- Clarify crucial principles and key elements of GCP
- Be able to identify what is indispensable for sponsors and research sites
- Explain accurate documentation according to GCP
- Identify what GCP means during the life cycle of clinical investigations
- Delineate the legal context of GCP and inspection procedures
- Exemplify inspection findings with frequently occurring non-compliances
- Develop a GCP-mindset
Who should attend
This GCP online training is developed for people who need to acquire GCP awareness without going into details.
No specific experience is required: people from various backgrounds and departments (Senior Management, Regulatory Affairs, Biometrics, Data Management, Medical Writing, Laboratory, Pharmacovigilance, …) can benefit.Competencies
This course covers competencies that are part of the ECCRT Competency Framework
- Scientific Concepts & Research Design (0)
- Ethical & Participants Safety Considerations (0)
- Investigational Product Development and Regulation (2)
- Clinical Studies Operations (GCPs or ISO 14155) (4)
- Study and Site Management (0)
- Data Management and Informatics (2)
- Leadership and Professionalism (0)
- Communication (0)
- Teamwork (0)
- Business acumen (0)
Be aware that attending one of ECCRT open course does not guarantee that the competency is acquired but only guarantees that the related knowledge has been trained.
Trainers
Stephan Duparc
Medicines for Malaria Venture
David Reddy
Medicines for Malaria Venture
Vaiva Deltuvaite-Thomas
IDDI