CTA template will save time
From 27 February 2025 , the new template Clinical Trial Agreement (CTA) is also available on the CCMO website in English. All parties involved have given their blessing to this template for medical research under the Dutch WMO Act and the European regulations MDR and IVDR. Using this template will save sponsors and participating centres a lot of time. The publication and implementation of the template is therefore an important part of the National Clinical Research Action Plan.
A detailed guidance to the template is available as well. This guidance clarifies articles and includes recommendations when using the template.
Less coordination needed
This template was developed and agreed upon jointly by parties united in the Dutch Clinical Research Foundation (DCRF). The parties involved are:
- Cooperating Top Clinical Teaching Hospitals (STZ),
- Dutch Federation of University Medical Centres (NFU),
- Association Innovative Medicines (VIG),
- Dutch Cancer Institute - Antoni van Leeuwenhoek Hospital Foundation (NKI/AvL),
- Association of Contract Research Organisations in the Netherlands (ACRON)
- Princess Máxima Centre Centre for Paediatric Oncology (Máxima).
If, in exceptional cases, an adaptation of the CTA template is nevertheless necessary, the deviation from a clause is preferably recorded in an annex.
Living document
Because developments in daily practice may also require adjustments, this template is a living document. The DCRF will actively ask users for feedback. In addition, users may report problems and suggestions through their own umbrella organisations or directly to the DCRF at secretariaat@dcrfonline.nl . The feedback received will be reviewed by a DCRF working group in which stakeholders are represented. Any changes to the template will be reported via the DCRF and CCMO websites.
Use of template strongly recommended
To speed up the submission process, use of the (unmodified) CTA template is strongly recommended.
Please note that hospitals and companies may need up to three months to set up their systems to use the new template CTA. The DCRF assumes that from mid-May 2025, the new template will be commonplace. As mentioned, an important step in the National Action Plan, driven by the love of clinical research.
In the time to come, DCRF will pay extra attention to the implementation of the template.