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 In the new working method, the Research Declaration has been replaced by the Site Suitability Declaration (VGO).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

[toggles title="Module:  Introduction to VGO"]
You'll learn about the following:

• 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

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

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

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