Introductory Course to the Site Suitability Procedure for Clinical Trials in the Netherlands

This online course teaches you what you need to know about the new procedure for local feasibility and the Site Suitability Declaration (VGO). The interactive and self-paced online training is developed in co-creation with the DCRF Local Feasibility Working Group. It consists of 1 online training module that can be completed within 1,5 hours and a test of 8 questions at the end. Learn about the VGO at your own pace and time with us.

 50.00

Additional information

Job Role

, , , ,

Language

,

Level

Phase of Study

Region of Regulation

Regulation

Accreditation

, , ,

Need more than 5 licenses?

Connect with our corporate team to discuss your organization’s learning needs and discover how our training solutions can help transform your business.

Category: Tag:

Introductory Course to the Site Suitability Procedure for Clinical Trials in the Netherlands

 50.00

This online course teaches you what you need to know about the new procedure for local feasibility and the Site Suitability Declaration (VGO). The interactive and self-paced online training is developed in co-creation with the DCRF Local Feasibility Working Group. It consists of 1 online training module that can be completed within 1,5 hours and a test of 8 questions at the end. Learn about the VGO at your own pace and time with us.

Category: Tag:

LEARNING OBJECTIVES

You'll specifically learn about:

  • the VGO and the Local feasibility procedure and how it applies to all WMO research in the Netherlands
  • the purpose of the Local feasibility procedure
  • the possible results of increasing the speed and efficiency of local feasibility processes
  • the main elements of the Local feasibility procedure
  • the documents need to be revised following input from the METC during the review procedure
  • that the VGO is a statement by which the Board of Directors declares that the institution is suitable
  • that only Part A of the VGO is submitted and the Appendices do not leave the hospital
  • which document templates are available on the website of the CCMO
  • the timelines for the delivery and signing of the CTA, the protocol, and the VGO

 

DESCRIPTION

The procedure for submitting a local feasibility declaration for research subject to the WMO, the so-called Local Feasibility procedure, will change in 2021. In the new working method, the Research Declaration has been replaced by the Site Suitability Declaration (VGO). The period December 1, 2020, to the end of 2021 is a transition period in which sponsors can choose whether they use the Research Declaration or the VGO to assess the suitability of the participating centers.

Use of the VGO will become mandatory from a date to be determined in 2021. Learn about the new procedure and the VGO to be prepared for this change!

In this training, all steps of the new Local Feasibility procedure are explained on the basis of a recognizable case. The training is suitable for (principal) investigators, research nurses, research coordinators, and other employees at research centers. The training is also suitable for employees of pharmaceutical companies and CROs who are involved in the (preparation of) submission of the submission dossier.

  • Recognized certificate
  • Efficient and interactive online learning
  • Easily accessible via smartphone, tablet, or desktop
  • Modular learning at your own pace

This online training has been developed in close collaboration with the DCRF Working Group Local Feasibility with contributions from experts from STZ hospitals, UMCs, general hospitals, pharmaceutical companies, CROs, and Platform Researchers Networks. 20% of the training fee will be donated to the DCRF.

The training consists of 1 online training module and represents a total workload of 1.5 hours.

 

COURSE CONTENTS

Module: Introduction to VGO

Module: Knowledge Test

Additional information

Job Role

, , , ,

Language

,

Level

Phase of Study

Region of Regulation

Regulation

Accreditation

, , ,

Reviews

There are no reviews yet.

Be the first to review “Introductory Course to the Site Suitability Procedure for Clinical Trials in the Netherlands”

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.

Reviews

Be the first to review “Introductory Course to the Site Suitability Procedure for Clinical Trials in the Netherlands”

Do you know someone who would like this course? Tell them about it…