LEARNING OBJECTIVES
- Principles of ICH GCP and the ICH GCP Addendum R2
- EU Directives 2001 & 2005
- Roles in clinical research
- Abbreviations and terminology
- Review procedures ethics committee and the competent authority
- IEC submission requirements, timelines, and decisions
- Composition of a standard research dossier
- Terms and obligations after approval
DESCRIPTION
The Introductory GCP course is the ideal introduction to Good Clinical Practice (GCP) and the submission of clinical research files in Europe. It gives you the tools you need to compose the standard research file, how to submit the files to the ethical review committee, and any conditions and obligations you are facing after approval.
This course is specifically tailored to the requirements of the European regulatory framework and helps anyone involved in the submission phase of clinical trials in Europe. It is an ideal introductory course for sponsor and CRO staff, clinical trial assistants, and research coordinators.
- Efficient and interactive online learning
- Easy accessible via smartphone, tablet or desktop
- Self-paced and modular
The course consists of 2 online training modules: introduction and Submission of a clinical trial. It represents a total workload of 2 hours. The modules are divided into chapters of 10 minutes and consist of the guidelines which apply to clinical trials in Europe, including the Declaration of Helsinki, ICH GCP E6 Addendum R2, and the EU Directives. If you require additional knowledge for the execution of other phases of the trial, you can easily add these modules by upgrading to an Expert online GCP training package.
After you have completed all components of the Introductory GCP e-learning course, you will receive a Certificate.
All training courses include one-year access to the online training. With our continuous learning model, we will keep you up-to-date with changing regulations and guidelines.
Enroll now to get started with the online learning modules on your smartphone, tablet, or desktop computer.
COURSE CONTENTS
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You’ll learn the following in this module:
- Introduction to medical research
- Types of clinical research (interventional, therapeutic, multi/single center)
- History of legislation and regulations clinical research (Code of Nuremberg, Declaration of Helsinki)
- The principles of ICH GCP incl. R2 Addendum
- Laws and regulation clinical research Europe (EU directives 2001 and 2005, EU Regulation 536/2014)
- The roles in clinical research (sponsor, IEC, competent authority, monitor, auditor, investigator, research professional)
- Additional requirements for clinical trials of a medicinal product
- Phases of a clinical trial of a medicinal product
- Abbreviations and terminology in medical scientific research
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You’ll learn the following in this module:
- Composition of standard research file
- Composition and procedure reviewing committee
- Review by an ethics committee
- Review by the competent authority
- Review deadlines and changes
- Review process and approval
- Terms and obligations after approval
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matyas@igina.net –
It was a good experience taking up the GCP course. The training & learning materials were awesome, which included the content. Overall, I am satisfied and highly recommend GCP Central for online training courses.