Follow us on  LinkedFit for Health LinkedIN

At what stage of proposal submission/implementation is it necessary to provide the protocol?


For each Horizon 2020 clinical study, three mandatory deliverables (Annex 2 of the template 'Essential information to be provided for clinical trials…’) have to be included in the proposal, whereby the first mandatory deliverable (due prior to enrolment of first study subject) requests a final version of the study protocol. Mandatory deliverables:

1. 'First study subject approvals package' (prior to enrolment of first study subject):
a. Final version of the study protocol
b. Registration number of clinical study
c. Regulatory and/or ethics approvals

2. 'Midterm recruitment report‘ (to be scheduled for the time point when 50% of the study population is expected to have been recruited)

3. 'Report on status of posting results' in the study registry(s) (to be scheduled for the time of expected results posting or for the last months of the project, whichever comes earlier)