UPDATE ON PREVIOUS ANNOUNCEMENTS REGARDING THE NEW SITE SUITABILITY DECLARATION/VGO
As of 1st November, the VGO became mandatory for drug trials, replacing the current Research Declaration for studies subject to the Medical Research Involving Human Subjects Act (WMO) in the Netherlands.
This means that since 1st November, you’re no longer allowed to submit the old Research Declaration for the assessment of the suitability of participating centres.
VGO cuts life-threatening delays
Implementation of the VGO signifies a strong step forward towards a faster and more streamlined process from the initial Research Declaration until the start of the study. By pulling the local feasibility assessment forward, the VGO cuts out the time delay that currently exists between the Ethical Committee’s positive decision and the study’s starting date.
Shortening the total timeline has multiple major consequences:
- Improved health care: the sooner trials and studies conclude, the sooner their results can be used to develop new innovative treatments and to make new medicines available to patients;
- More efficient use of resources since delays in research are costly;
- Global relevance: “If we, the Netherlands, want to stay relevant as a research country, we have to make sure our research procedures are flawless. Any delays caused by the system itself have to be eliminated,” says Eric Klaver, Quality Consultant at Trial & Eric and advisor to Diagram Research.
Need help with the transition?
With Diagram’s commitment to quality and adherence to laws and regulations, we already integrated the VGO into our protocols. Reach out for support in implementing the new procedure Local Feasibility and the new Site Suitability Declaration (VGO). Click here to get in touch.