GCP Essentials in 90 minutes (R3) – eLearning
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| Date | Product | Location | Price | |
|---|---|---|---|---|
| GCP Essentials in 90 minutes (R3) | eLearning | USD 175 | Book | |
| If you would like to have this course as an in-house session click here | ||||
About this course
Reasons to attend
This GCP training (R3) 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 ICH GCP E6 (R3) and responsibilities 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
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
- Necessary resources, documents & records, and Handling of Essential Records for the conduct of a clinical trial
Learning objectives
Principles of GCP
- Understand the Rationale and objectives of ICH GCP Guidelines
- Explain what the ICH Good Clinical Practice guidelines include
- Describe the origins and history of ICH GCP in brief
- Understand the importance of compliance with the ICH Good Clinical Practice Guideline
- Understand the Data Governance requirements in ICH GCP
- Describe the responsibilities of the Independent Ethics Committee/ Institutional Review Boards, Investigators and Sponsors.
- Learn about the important activities and resources that are required in order to safeguard the rights, safety and well-being of all trial participants.
- Understand the necessary resources and documents and records
- Describe the purpose and content of the Investigator's Brochure
- Describe the purpose and content of the Clinical Trial Protocol and Protocol Amendments
- Describe the handling of the Essential Records for the Conduct of a Clinical Trial
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.
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