LEARNING OBJECTIVES
- Principles of ICH GCP and the ICH GCP Addendum R2
- Roles in clinical research
- Abbreviations and terminology
- How to start your study
- Recruitment of subjects
- Informing the subjects
- Requirements for research with vulnerable subjects
- Safety reports and safety of your subjects
- Trial amendments
- Documentation
- Quality Management
DESCRIPTION
The Fundamental GCP course is the ideal foundation for Good Clinical Practice (GCP), and starting and conducting international clinical trials. It gives you the tools you need to start your trial, recruit and inform your subjects, adhere to the requirements for research with vulnerable subjects, ensure the privacy of data, to deal with amendments, deviations, and changes in protocol and research, adding new research locations and researchers, ensure a high level of quality and risk management, and have all safety measurements and reports in place.
This course is tailored to the international ICH GCP regulatory framework and helps anyone involved in the start and conduct phase of international clinical trials. It is an ideal fundamental course for students, research coordinators, investigators, clinical trial site staff, and research nurses.
- Efficient and interactive online learning
- Easy accessible via smartphone, tablet or desktop
- Self-paced and modular
The course consists of 3 online training modules: Introduction, Start, and Conduct of a clinical trial. It represents a total workload of 4 hours. The modules are divided into chapters of 10 minutes and consist of the guidelines which apply to international 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 GCP training package.
After you have completed all components of the Fundamental 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:
- Delegate tasks and Initiation Visit
- Supply, storage, and use of the investigational product in a trial
- Recruitment of subjects
- Informing subjects
- Informed Consent procedure
- Randomization and coding
- Privacy of data
- Requirements for research with vulnerable subjects
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You’ll learn the following in this module:
- Amendments, deviations, and changes in protocol and trial
- Adding new research sites and investigators
- Safety reports (AE / SAE)
- Safety subjects medical care and DSMB
- Documentation and data management (source, CRF, database)
- Monitoring/ Auditing/ Inspection
- Quality assurance and risk management
- Progress reports
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