LEARNING OBJECTIVES
- Principles of ICH GCP and the ICH GCP Addendum R2
- EU Directives 2001 & 2005
- Declaration of Helsinki
- Privacy laws EU (GDPR)
- Roles and responsibilities in clinical research
- Abbreviations and terminology
- Development of trial protocol
- Selection of site and research staff
- Setting up quality assurance: monitoring plan, auditing, DSMB, SOPs
- Agreements
- Review procedures
- Terms and conditions
- Recruitment of subjects and requirements for research with vulnerable subjects
- Safety, including reporting of SUSARs
- Documentation
- Quality Management
- Completion and archiving of clinical trials
DESCRIPTION
The expert course to GCP in Europe is the self-paced online training solution for researchers, pharma professionals, and research staff who conduct clinical trials in Europe, and need to be aware of the Good Clinical Practice guidelines and EU laws 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 regulatory 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, ICH GCP E6 Addendum R2, EU Directives 2001, and 2005 and the EU Privacy law.
After you have completed all components of the GCP e-learning course, for clinical trials in Europe 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 online learning modules on your smartphone, tablet, or desktop computer.
COURSE CONTENTS
Module 1: 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 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
Module 2: Design You’ll learn the following in this module:
- 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 3: Preparation You’ll learn the following in this module:
- Packaging, labeling, importing, and supplying investigational products
- Compose product information (Investigator’s Brochure, IMPD)
- Draw up patient information and other trial documents
- Contracts and Agreements
- Privacy laws EU (GDPR)
- Insurance (Trial Insurance and Liability)
Module 4: Submission You’ll learn the following in this module:
- 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 5: 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
Module 6: 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
Module 7: Archive (Close-out) You’ll learn the following in this module:
- Regular completion of a trial
- Preliminary closing of a trial
- Report end of the trial
- Requirements for Clinical Study Report
- Storage and archiving trial documentation
- Retention deadlines for trial documentation
Published –
The GCP course was excellent! I appreciate the online, self-paced learning.