Horizon Europe Cluster 1 Health: use of Clinical Studies template

The following additional information was provided concerning the 'Template for essential information to be provided for proposals including clinical trials/studies/investigations/cohorts' (under FAQ on the Funding and Tender Portal):

The use of the template is MANDATORY IF the application includes a clinical study AND it concerns one of the following topics: HORIZON-HLTH-2021-CORONA-01-01; HORIZON-HLTH-2021-CORONA-01-02;HORIZON-HLTH-2022-STAYHLTH-01-01-two-stage; HORIZON-HLTH-2021-STAYHLTH-01-02; HORIZON-HLTH-2022-STAYHLTH-01-04-two-stage; HORIZON-HLTH-2022-STAYHLTH-01-05-two-stage; HORIZON-HLTH-2022-STAYHLTH-02-01;HORIZON-HLTH-2021-ENVHLTH-02-01; HORIZON-HLTH-2021-ENVHLTH-02-02; HORIZON-HLTH-2021-ENVHLTH-02-03;HORIZON-HLTH-2021-DISEASE-04-01; HORIZON-HLTH-2021-DISEASE-04-03; HORIZON-HLTH-2021-DISEASE-04-04; HORIZON-HLTH-2021-DISEASE-04-07; HORIZON-HLTH-2022-DISEASE-06-02-two-stage; HORIZON-HLTH-2022-DISEASE-06-03-two-stage; HORIZON-HLTH-2022-DISEASE-06-04-two-stage; HORIZON-HLTH-2022-DISEASE-07-03;HORIZON-HLTH-2021-TOOL-06-01; HORIZON-HLTH-2021-TOOL-06-03; HORIZON-HLTH-2022-TOOL-11-01; HORIZON-HLTH-2022-TOOL-11-02; HORIZON-HLTH-2022-TOOL-12-01-two-stage.

If a concerned application is submitted without the duly filled-in template, then it will be considered as incomplete (missing crucial information) and fail the admissibility criterion.

Applicants should upload the dedicated Annex ‘Essential information for clinical trials/studies/investigations/cohorts’ (a Word template is provided under ‘download templates’ in the upload section for Part B and Annexes). This document should include the relevant information of each clinical study included in the work plan of the project proposal. ONE template is to be used per EACH clinical study, however, only one file can be submitted. Therefore, in case of multiple clinical studies, all the completed templates should be converted into one pdf or merged into a long document containing all the completed templates.

Note: For a stage-1 proposal, this template cannot be uploaded as a separate document at stage 1, but relevant aspects of the clinical study should be integrated into part B of the stage 1 proposal template.

Definition: Clinical study means any systematic prospective or retrospective collection and analysis of health data obtained from individual patients or healthy persons in order to address scientific questions related to the understanding, prevention, diagnosis, monitoring or treatment of a disease, mental illness, or physical condition. It includes but it is not limited to clinical studies as defined by Regulation 536/2014 (on medicinal products), clinical investigation and clinical evaluation as defined by Regulation 2017/745 (on medical devices), performance study and performance evaluation as defined by Regulation 2017/746 (on in vitro diagnostic medical devices).

Source: Funding and Tender Portal