Clinical studies annex & Clinical trials regulation (Horizon Europe)

For calls that involve clinical studies (mainly under Horizon Europe Health Cluster, Cancer Mission, the Global Health-EDCTP3 Joint Undertaking and the Innovative Health Initiative (IHI)) applicants must add the Clinical Studies Annex to their proposal application and upload it as separate annex in the Submission System. Find the most recent version of the Annex attached ('information-on-clinical-studies-he-en'). 

The network of Health NCPs, HNN3.0, offers an annotated template of the Clinical Studies Annex with information and tips on how to fill it out. You can find it in attachment. The network organised a webinar recently on the subject which you can rewatch here. 

Why a clinical studies annex?

Clinical studies have a number of methodological, operational and regulatory specificities. Information on these issues is crucial for evaluators to assess the scientific quality and operational feasibility of the proposal. Information provided on this in the annex does not need to be repeated elsewhere in the proposal but can be referred to. There are no page limitations for this annex, but the Commission asks to keep explanations as consice as possible.

Applicability

For Horizon Europe collaborative R&I proposals:

Single-stage and stage-2 proposals: The use of this template is mandatory for single-stage or stage-2 proposals, if the application includes a clinical study AND it concerns a topic including clinical studies. For these topics, you will have the possibility to upload the completed template as a separate part of your application in the submission system.

Stage-1 proposals: In the limited frame of a stage-1 proposal, not all methodological details of clinical studies can be fully elaborated. Depending on the characteristics of the study, however, key aspects of clinical study have to be convincingly addressed already at stage 1. This template cannot be uploaded as a separate document at stage 1, but relevant aspects of this information should be integrated in part B of the stage 1 proposal template.

For Horizon Europe IHI JU and Global Health-EDCTP3 JU proposals:

Single-stage and stage-2 proposals: The use of this template is mandatory for all clinical studies. You can upload the completed template as a separate part of your application in the submission system.

Stage-1 proposals: see under Horizon Europe collaborative R&I proposals

For proposals containing clinical studies submitted to topics not foreseeing clinical studies:

The Commission instructs applicants to use the section headings of the clinical studies annex as an orientation and provide the related information in sections B.1 and B.3 of the proposal, if the submission system does not provide the possibility to upload the template.

Definition 'clinical study'

Clinical study covers clinical studies/trials/investigations/cohorts and means, for the purpose of this document, 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).

Clinical studies annex & Clinical trials regulation

In April 2023, the clinical studies annex was updated in order to include a reference to the mandatory use of Clinical Trials Information System (CTIS). What you need to know about CTIS:

If your application includes clinical trials, note that the EU pharmaceutical legislation known as the Clinical Trials Regulation No 536/2014 entered into application on 31 January 2022, repealing the Clinical Trials Directive (EC) No. 2001/20/EC and national implementing legislation in the EU Member States, which regulated clinical trials in the EU until the Regulation's entry into application. As a result, from 31 January 2023, all initial clinical trial applications in the EU must be submitted via the Clinical Trials Information System (CTIS). CTIS is now the single-entry point for sponsors and regulators of clinical trials for the submission and assessment of clinical trial data. 

The Clinical Trials Regulation foresees a three-year transition period, from 2022 to 2025. By 31 January 2025, all ongoing trials that were approved under the Clinical Trials Directive will be governed by the new Regulation and will have to be transitioned to CTIS.