LEARNING OBJECTIVES
- Principles of ICH GCP and the ICH GCP Addendum R2
- EU Directives 2001 & 2005
- Roles in clinical research
- Abbreviations and terminology
- How to start your study
- Investigational product
- Recruitment of subjects
- Informing subjects (GDPR updated)
- Including subjects
- Screening
- Vulnerable subjects
- Safety reports and safety subjects medical care
- SAEs and SUSARs
- Trial amendments
- Documentation
- Quality management
DESCRIPTION
The Fundamental GCP course is the ideal foundation for Good Clinical Practice (GCP), and starting and conducting clinical trials in Europe. 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 specifically tailored to the European regulatory framework and helps anyone involved in the start and conduct phase of clinical trials in Europe. 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 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 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 myGCP learning modules on your smartphone, tablet, or desktop computer.
COURSE CONTENTS
[toggles title=”Module: Introduction”] 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
[/toggles] [toggles title=”Module: Start”] 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 (GDPR)
- Requirements for research with vulnerable subjects
[/toggles] [toggles title=”Module: Conduct”] 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 / SUSAR)
- Safety subjects medical care and DSMB
- Documentation and data management (source, CRF, database)
- Monitoring/ Auditing/ Inspection
- Quality assurance and risk management (R2 Addendum)
- Progress reports
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matyas@igina.net –
I also found the GCP training useful concerning the study materials and other reference materials provided to us.