LEARNING OBJECTIVES
- Principles of ICH GCP and the ICH GCP Addendum R2
- EU Directives 2001 & 2005 and the European Clinical Trial Regulation (ECTR)
- Update to the Medical Research Involving Human Subjects Act (WMO)
- EU Privacy regulation (GDPR)
- Research with medical devices
- Safety reporting for drug and medical device research
- Publication of research results, FAIR data principles
- Insurance for subjects
- Requirements for research with minors
- Monitoring, auditing, and inspections
DESCRIPTION
Are you registered in the Dutch GCP-WMO register and is your registration about to expire? Successful completion of the Re-certification WMO GCP course for Clinical Trials in the Netherlands extends your registration in the GCP-WMO register with 3 years.
This online Re-certification WMO GCP course is suitable for experienced researchers and research staff who are registered in the GCP-WMO register, managed by EMWO.
In this course, you will learn about all changes in the applicable legislation, including Medical Research Involving Human Subjects Act (WMO), the EU Clinical Trial Regulation, ICH GCP Addendum R2, and the GDPR Privacy legislation. The course also explains the requirements for research with medical devices, quality assurance, and risk management, scientific integrity, multicenter research.
After your successful completion of the course, we will inform EMWO who will extend your registration in the GCP-WMO register with 3 years. You will receive notification from EMWO when this has happened.
PLEASE NOTE. Check if you are registered in the GCP-WMO register. This course is only applicable for researchers and research staff who have an active registration in the GCP-WMO register. In case your registration has expired, or if you are not registered, we recommend to take the Expert Course to WMO GCP Course to Clinical Trials in the Netherlands
COURSE CONTENTS
Module: Introduction
- The principles of ICH-GCP incl. R2 Addendum
- Declaration of Helsinki
- EU directives 2001 and 2005, EU Clinical Trial Regulation 536/2014
- Recent changes to laws and regulation clinical research the Netherlands (WMO, WGBO)
- Privacy regulation GDPR
- Additional requirements for clinical trials of a medicinal product
- Requirements for research with medical devices – Directives&Regulation (EU) 2017/745
- Review procedure non-WMO research
- Codes for proper use of human tissue for medical research
Module: Design
- Setting up quality assurance
- Risk inventory and assessment
- Data Safety Monitoring Board
- Setup of monitoring and monitoring plan according to ICH GCP R2 and guidelines of NFU)
- Setup of SOPs and Auditing
- Scientific integrity for data collection
- Research codes
- Fraud, plagiarism and the Code of Conduct for the Use of Data in Health Research (FEDERA)
Module: Preparation
- Contracts and agreements, incl. CTA templates for the Netherlands
- Insurances: Declaration of human subject insurance according to Compulsory Insurance Decree in Medical Research Involving Suman Subjects
- Insurances: requirements for liability insurances
Module: VGO
- The process
- Visualization of the Local Feasibility procedure
- For which types of research does the VGO apply?
- The 4 steps of the Local Feasibility procedure
- Part A and Part B of the VGO
- Relationship between VGO and other documents
- The timelines of the Local Feasibility procedure
Module: Submission
- Composition and procedure reviewing committee (ethics committee or CCMO)
- Review by an ethics committee
- Review by the competent authority (CCMO or Ministry of Health)
- Local feasibility/approval
- Review of multicenter studies
- Review deadlines and changes
- EU Clinical Trial Regulation: process and timelines submission and review
- Notification of medical devices research to the Health Authority
Module: Start
- Data privacy: GDPR and patient data
- Use of CCMO template Patient Information / Informed Consent
- Changes in the requirements for research with vulnerable subjects
Module: Conduct
- Safety subjects medical care and DSMB
- Publishing safety reports (AE / SAE / SUSAR) via Toetsingonline
- Reporting AE/SAE/SADE for medical devices research
- Quality assurance and risk management (R2 Addendum), incl. progress reports
- Monitoring during the trial
- Amendments, deviations, and changes in protocol and trial
Module: Archiving (Close-out)
- Publication in trial registers
- Publication of data and clinical trial results
- Additional requirements for medical device research and research with medicinal products
Module: Knowledge Test
- 40 questions
- Available in Dutch
- Feedback per question (afterwards)
- 3 attempts
- Online certificate with a score of 80 or higher
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Re-certification course:
Very nice presentation of the material, good to read, easy to go forward and backward. Nice lay out
matyas@igina.net –
Very practical and to the point training. Quick and superficial if you want, but enough click-through material if need in-depth training