The ERA4Health partnership is working to develop an EU-harmonised clinical trial site template to facilitate the conduct of academic multinational clinical trials in Europe.
Multinational trials can be challenging to operationalise due to incompatibilities between country-specific policies and infrastructures. Facilitating the contracting of clinical trial sites, especially for multinational trials, is key to ensure the efficient conduct of trials. Increased harmonisation of templates for clinical trial contracts at EU level (EU Clinical Trial Agreement [CTA]) will facilitate the conduct of multinational trials in Europe and contribute to a better integration of clinical research into the European healthcare system.
The objectives of the survey are
- Gather information on existing CTA templates/models across the EU;
- Gain a broader understanding of the issues faced by academic sponsors of multinational clinical trials and other relevant stakeholders when dealing with and negotiating CTAs in the context of multinational clinical trials,
- Identify the negotiable and non-negotiable national specificities (e.g. legally binding provisions) of CTAs
- Find a common understanding of what an EU CTA template should look like so that it can be used as a model in the context of academic multinational clinical trials.
Target audiences:
- Academic sponsors of multinational trials in Europe
- Investigational sites involved in academic multinational trials in Europe
- CROs (Clinical Research Organization) and CTUs (Academic Clinical Trial Units)
- Any other actor involved in the development of national procedures/templates for harmonisation of CTAs (governmental agencies and authorities)
The survey will be open until 30 September 2024.