- Principles of ICH GCP and the ICH GCP Addendum R2
- Roles in clinical research
- Abbreviations and terminology
- Preparation of product information (IB/IMPD)
- Creation of patient information (PIF/IC form)
- Compensation and insurance
The Introductory ICH GCP course is the ideal introduction to Good Clinical Practice (GCP) and preparing international clinical trials. It gives you the tools you need to prepare product information, arrange the required insurances, setup Patient Information documentation, and have all necessary contracts and agreements in place.
This course is specifically tailored to the requirements for clinical trials in ICH regions and helps anyone involved in the start-up phase of international clinical trials. It is an ideal introductory course for students, research coordinators, CRAs, pharmacists, sponsors, and research staff.
- 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 Preparation 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.
- 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
- Packaging, labeling, importing and supplying investigational products
- Compose product information (Investigator’s Brochure)
- Draw up patient information and other trial documents
- Contracts and Agreements
- Insurance (Trial Insurance and Liability)