(2 customer reviews)

Re-Certification WMO GCP Course for Clinical Trials in the Netherlands

This course was previously called “WMO-GCP Re-certification”. The online GCP re-certification course is applicable to researchers and research staff registered in the Dutch GCP-WMO register (EMWO) who need re-certification after 3 years of being registered. Includes 7 interactive modules.

 125.00

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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

[toggles title=”Module:  Introduction”]
You’ll learn the following in this module:

  • 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

[/toggles]

[toggles title=”Module:  Design”]
You’ll learn the following in this module:

  • 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)

[/toggles]

[toggles title=”Module:  Preparation”]
You’ll learn the following in this module:

  • 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

[/toggles]

[toggles title=”Module:  Submission”]
You’ll learn the following in this module:

  • 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

[/toggles]

[toggles title=”Module:  Start”]
You’ll learn the following in this module:

  • Data privacy: GDPR and patient data
  • Use of CCMO template Patient Information / Informed Consent
  • Changes in the requirements for research with vulnerable subjects

[/toggles]

[toggles title=”Module:  Conduct”]
You’ll learn the following in this module:

  • 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

[/toggles]

[toggles title=”Module:  Archiving (Close-out)”]
You’ll learn the following in this module:

  • Publication in trial registers
  • Publication of data and clinical trial results
  • Additional requirements for medical device research and research with medicinal products

[/toggles]

[toggles title=”Module: Knowledge Test”]
The knowledge test includes:

  • 40 questions
  • Available in Dutch
  • Feedback per question (afterwards)
  • 3 attempts
  • Online certificate with a score of 80 or higher

[/toggles]

Learn anytime, anywhere

Learn at your own pace on your smartphone, tablet or desktop. You will have one year of access to the training and resources so you can look up information even after you’ve completed the course.

Learn Continiously

Continuous Learning can both improve clinical research quality and ensure a motivated research team. You’ll benefit from better knowledge retention and reduced risks.  We When a regulatory update is announced, we update the training modules and notify you, so that you can take the updated module and earn a new GCP certificate.

Earn your gcp certificate

With our courses, you can earn and maintain your vital industry-recognized certificate. In your GCP Passport, you can now see exactly which version of a training module you were most recently trained on. This documentation in combination with the changelog will inform auditors, managers, and inspectors of the associate’s compliance with current regulations.

2 reviews for Re-Certification WMO GCP Course for Clinical Trials in the Netherlands

  1. .

    Re-certification course:
    Very nice presentation of the material, good to read, easy to go forward and backward. Nice lay out

  2. 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

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