LEARNING OBJECTIVES
- Principles of ICH GCP and the ICH GCP Addendum R2
- Roles in clinical research
- Abbreviations and terminology
- Regular study completion and report end of the trial
- Early termination
- Requirements for Clinical Study Report
- Archiving of trial documentation and retention period
DESCRIPTION
The Introductory ICH GCP course is the ideal introduction to Good Clinical Practice (GCP) and archiving (close-out) of international clinical trials. It gives you the tools you need to deal with early termination, report the end of the trial, requirements of the Clinical Study Report, and archiving and retention periods of your essential documents.
This course is tailored to the international ICH GCP regulatory framework and helps anyone involved in the archive (close-out) phase of clinical trials. It is an ideal introductory course for students, research coordinators, CRAs, and research nurses.
- 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 Close-out 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, including the Declaration of Helsinki, and ICH GCP E6 Addendum R2. 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 ICH 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, including the E6 R2 Addendum
- Implementation in laws of Europe, Japan, USA, and other ICH regions
- The roles in clinical research (sponsor, review board, the 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:
- Regular completion of a trial
- Preliminary closing of a trial
- Report end of the study
- Requirements for final report / Clinical Study Report
- Storage and archiving trial documentation
- Retention deadlines for trial documentation
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matyas@igina.net –
This course was put together and executed well.