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 in-company blended GCP course for Clinical Research in Europe is the optimal mix for companies: your team learns about GCP guidelines and European Directives and Regulation online, at their own pace, and apply the GCP rules to company-specific situations in an instructor-led (virtual) classroom session at your company.
The self-paced online course gives a practical understanding of the ICH GCP guidelines and European legislation in a logical order: from design to the closeout of clinical trials. After completion of the 7 modules of the online course, the attendees have the knowledge to have in-depth discussions at the (virtual) classroom session.
The program of the classroom session is tailored to the needs of the attendees and allows maximum interaction. They are challenged to apply their GCP knowledge to solve company-specific case studies. They will exchange knowledge and experiences with their colleagues and have in-depth discussions with the experienced trainer to maximize their learning experience.
This course is ideal for teams working on European clinical trials and experienced staff looking for an extensive update on ICH GCP and the current European legislation.
The completion of the training takes 10 hours, including 6 hours of online learning and a virtual* classroom session of 4 hours. (*We provide virtual classroom training due to corona restrictions)
After the attendees have completed all components of the blended GCP course for Clinical Trials in Europe, they will receive a GCP Certificate, recognized by Transcelerate.
All training courses include one-year access to online training. With our continuous learning model, we will keep your team 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 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: 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, IMPD)
- Draw up patient information and other trial documents
- Contracts and Agreements
- Privacy laws EU (GDPR)
- Insurance (Trial Insurance and Liability)
Module: Submission
- Composition of standard research file
- Composition and procedure reviewing committee
- Review by an ethics committee
- Review by a 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 (GDPR)
- 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 / 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: Archive (Close-out)
- 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
Module: (Virtual) classroom session (tailor-made)
- Apply GCP knowledge to company-specific situations and case studies
- Discuss remaining questions with the trainer and colleagues
- Get detailed insights into topics of interest or specific company policies
matyas@igina.net –
The GCP blended training of GCP Central is a very complete, easy to understand training on GCP. The online part is very clearly written. I could do it on all my devices (tablet, laptop, desktop, phone). Also, I could start, stop, and re-start at my own time. The ‘classroom’ part is interactive, I could ask all the questions I had at the moment I had them. I also got some more background information on the development of GCP and other rules- and regulations, which is very useful for me. I enjoyed following this training, both the online part and the ‘classroom’ part.