You’ll specifically learn about:
- the principles and background of ICH Good Clinical Practice (GCP)
- the responsibilities of the Sponsor according to section 5 of ICH GCP in all stages of the trial
- the ethical and scientific quality standards that lead to reliable trial results
- quality management, internal quality controls, and quality assurance during the trial set-up
- the sponsor’s involvement in gathering data and preparing documents to submit to the IRB/IEC, the reviewing committee
- the ethical review that happens prior to the first subject entering a trial
- the sponsor’s role during the trial including monitoring the quality of the conduct of the trial, IP Management, Safety, and quality controls
- the requirements for closing the trial and archiving
The expert course to ICH GCP for Sponsors is the self-paced online training solution for clinical research professionals who initiate and monitor international clinical trials in ICH regions. It is specifically for those who need to be aware of the sponsor responsibilities as laid down in Chapter 5 of the Good Clinical Practice guidelines applicable to clinical research with human subjects.
This training is applicable for CRA’s, research coordinators, sponsor’s and initiating investigators. It allows you to initiate clinical research in ICH and is the best choice for those who like the flexibility of online learning at their own pace and time. This course translates the GCP framework to practice and gives you the tools to directly implement the knowledge in your daily practice.
• acknowledged GCP certificate
• Efficient and interactive learning
• Easy accessible via smartphone, tablet, or desktop
• Self-paced and modular
The course consists of 6 online training modules in a logical order: from the design to the close-out 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.
After you have completed all components of the ICH GCP e-learning course, you will receive a GCP Certificate. This course complements the Expert ICH GCP for Investigators which fulfills TransCelerate Biopharma’s minimum requirements for the mutual recognition of GCP training for investigators.
All training courses include one year of access to 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.
- The Sponsor and ICH-GCP
- Principles of ICH-GCP
- Uniformity to Reliability
Module: Trial Set-Up
- Essential Documents
- Quality Management
- Internal Quality Control
- Quality Assurance
Module: Trial Preparation
- Investigational Product
- Investigator Selection
- Trial Subject Information
- Clinical Trial Review
- Continued Review
Module: Start & Conduct
- IP Management
- Safety, Definitions & Reporting
- Quality Control
Module: Close-Out & Archiving
- Trial & Site Close-out
Module: Knowledge Test
- 25 questions
- Available in English
- Feedback per question (afterwards)
- 3 attempts
- Online certificate with a score of 80 or higher