The European Commission has now published the new template for clinical trials in Horizon 2020 health calls. The template was introduced at the Health Info Day 2015 in September and is specifically mandatory for clinical studies included in proposals submitted to topics PM-01, PM-02, PM-06, PM-07, PM-08, PM-09, PM-10, PM-11 and HCO-07. For these selected topics, applicants will be able to upload the completed template separatly to the submission system.
Major changes to the earlier template are in section 1.2 'Study Design and endpoints' and 1.7 'Conduct'. In addition, Annex 2: 'Mandatory deliverables for clinical studies' has been added. One new mandatory deliverable of clinical trials has been introduced – the midterm recruitment report is scheduled for the time point when 50% of the study population is expected to have been recruited. The report will include an overview of recruited subjects by study site, potential recruiting problems and a detailed description of implemented and planned measures to compensate delays (if applicable).
More information about the clinical studies in 'health, demographic change and well-being' societal challenge calls can be found in the presentation 'Clinical Studies in H2020 Proposals' held at the Health Info Day 2015. The template as well as all presentations and videos of the event can be found on the EC Research & Innnovation - Health website.