LEARNING OBJECTIVES
- Principles of ICH GCP and the ICH GCP Addendum R2
- Roles in clinical research
- Abbreviations and terminology
- Develop trial protocol
- Selection of research sites and staff
- Setting quality assurance: monitoring plan, auditing, DSMB, SOPs
- Essential documents
- Delivery, randomization, and blinding
- How to prepare product information
- How to inform your subjects
- Compensation and insurance
- Agreements
- Review procedures
- IEC/IRB submission
- Terms and conditions
- 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
- Regular study completion
- Early termination
- Archiving and close-out
DESCRIPTION
The expert course to ICH GCP is the self-paced online training solution for researchers, pharma professionals, and research staff who conduct international clinical trials in ICH regions and need to be aware of the Good Clinical Practice guidelines applicable to clinical research with human subjects. It 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.
- Transcelerate acknowledged GCP certificate
- Efficient and interactive learning
- Easy accessible via smartphone, tablet or desktop
- Self-paced and modular
The course consists of 7 online training modules in a logical order: from the design to close-out of a clinical trial. It represents a total workload of 6 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, recognized by Transcelerate.
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
Module: Introduction
- 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
Module: Design
- Protocol development and content
- Select research team
- Selection of investigators and research locations
- Selection criteria for researchers and research locations
- Create and store essential documents (Investigator Site File)
- Risk inventory and assessment
- Setting up quality assurance: monitoring plan, auditing, DSMB, SOPs
Module: Preparation
- 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)
Module: Submission
- Composition of standard research file
- Composition and procedure reviewing committee
- Review by an ethics committee
- Review by the competent authority
- Review deadlines and changes
- Review process and approval
- Terms and obligations after approval
Module: Start
- 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
Module: Conduct
- 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
Module: Archive (Close-out)
- 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
matyas@igina.net –
Very useful, great to have links to all documentation. Will keep many of the downloads as reference. Very well explained and touches upon all roles, responsibilities, and steps. Great for a starter.