You are here
Frequently Asked Questions (FAQ) - Template
For the purpose of the Template, a clinical study is defined as any clinical research involving a substantial amount of work related to the observation of, data collection from or diagnostic or therapeutic intervention on multiple or individual patients. It includes but is not limited to the clinical trials in the sense of the EU Clinical Trials Directive (2001/20/EC). So according to this definition would be regarded as a clinical trial.
Collecting data from or diagnostic or therapeutic intervention on multiple or individual patients is considered a clinical trial and the template needs to be submitted. If you are not sure, if your work would be considered a CT, we recommend to fill in the template to be on the safe side.
You should use the template as a guidance document. Although there is only limited space in stage 1 proposals, you should include all info that is important for the reviewers to understand what you are planning to do and that you have considered all important issues (according to the template).
For these topics you cannot upload the clinical trial template as a separate document, but you should use the template as a guiding document include this information in your proposal.
The template for essential information on clinical trials is mandatory at stage 2 (full proposal) for projects addressing all topics marked with an asterisk in the slides (slides are available on the FFH2.0 website) or indicated on the template.
You are supposed to fill in the template for each study, no matter how many study centers will be invlvoved in one study. If you have 3 Studies included in your project, you'll have sections 1-9 filled in for each of those (1.1, ...1.9; 2.1,...2.9 ....), please remember to upload everything as one single document.
There is one template consisting of 9 sections. All sections have to be completed for each study of your project. So there will be one single document to be uploaded containing information (section 1-9) for each study.
As a separate document.
Yes, this was a technical mistake.
In the version of August 2014 it is mentioned: " Single-stage- and stage-2 proposals: The use of this template is mandatory for all clinical studies included in a single-stage- or stage-2 proposal submitted to topics PHC-2, PHC-3, PHC-11, PHC-14, PHC-15, PHC-16, PHC-18, PHC-22, PHC-24, PHC-33 and HCO-62. For these topics, you will have the possibility to upload the completed template as a separate part of your application in the submission system."
The template can only be uploaded for those topics that are marked accordingly. For all other topics, you can use it as a 'checklist' to make sure you cover all relevant aspects, but cannot upload it. All info needs to be mentioned in the proposal body in those cases.
Annexes are to be uploaded with the full proposal, and yes, accessible for the evaluators. You do not have to repeat everything in the proposal body, but can be more concise there and make cross references to the annexes. In stage 1, you must be very brief, as the overall page limit is the same for all proposals, including those that entail clinical study elements.
Some of the information that is part of the protocol will also appear in the proposal body at places where you describe your study. The protocol as such can be included in a draft version as part of the extra documents that are to be uploaded. The final protocol does not have to be part of the proposal.