LEARNING OBJECTIVES
- ICH GCP and ICH GCP R2 Addendum
- EU Directives (2001 and 2005)
- Dutch legislation: Medical Research Involving Human Subjects Act (WMO), WGBO and Wet BIG
- Roles in clinical research
- Privacy in clinical research (GDPR)
- Informing research participants
- Essential documents
- Review by the Ethics Committee
- Safety reports and safety of your subjects, incl. AEs, SAEs, and SUSARs
- Quality management
- Amendments and derogations
- Final report
- Audits and inspections
DESCRIPTION
The in-company blended WMO GCP course for Clinical Research in the Netherlands is the optimal mix for companies: your team learns about GCP guidelines and Dutch (WMO) legislation online, at their own pace, and apply the GCP and WMO rules to company-specific situations in an instructor-led classroom session at your company.
The self-paced online course gives a practical understanding of the ICH GCP guidelines and the Medical Research Involving Human Subjects Act (WMO) 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 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 in the clinical research industry in the Netherlands or experienced staff looking for an extensive update on ICH GCP and WMO.
The completion of the training takes 12 hours, including 8 hours of online learning and a interactive classroom session of 4 hours.
After the attendees have completed all components of the blended WMO GCP course for clinical research in the Netherlands, they will receive a WMO/GCP Certificate, recognized by Transcelerate and accredited by many quality registers.
All training courses include one-year access to their online training. With our continuous learning model, we will keep your team up-to-date with changing regulations and guidelines.
COURSE CONTENTS
Module: 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)
- Legal framework for clinical research in the Netherlands (WMO, WGBO, Wet BIG, AVG) and scope
- The roles in clinical research: sponsor, METC, competent authority CCMO or Ministry of Health (VWS), monitor, auditor, researcher, 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
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: Preparation
You’ll learn the following in this module:
- Package, label, import and deliver a research product
- Drafting product information (Investigators Brochure, IMPD)
- Drafting patient information and informed consent with Model Subject Information 2019
- Contracts and agreements
- Privacy legislation (AVG)
- Insurance (subject insurance and liability)
Module: Submission
You’ll learn the following in this module:
- Composition of standard research file
- Composition and procedure of the review committee (METC or CCMO)
- Review by an ethical review committee
- Review by the competent authority: CCMO or Ministry of Health (VWS)
- Review timelines and submission of amendments
- Review process and approval
- Conditions and obligations after approval
Module: 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 (AVG)
- Requirements for research with vulnerable subjects
Module: 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: Close-Out (Archiving)
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
Module: Classroom session (tailor-made)
You’ll learn the following in this module:
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
Courses
Regulation
Job Role
Learn More
Learner
For Employers
matyas@igina.net –
One of the best educational experiences that I have ever had.