DONETs
How DONET works: from clinical question to study
A simple and structured procedure to develop a research project and prepare it for implementation within DONET.
How the process works – from idea to implementation
Completion of a research proposal form or interest in collaborating on an international clinical trial
Do you have a research idea, a clinical trial proposal or a clinical question that could form the basis for clinical research?
Or do you want to participate in an international clinical trial?
Fill out a simple form – together with you we will grasp the proposal, elaborate and prepare it for implementation or involvement.
Joint facilitation of the project proposal
The DONETs team with you:
✓ Defines the research objectives and study design,
✓ help to determine primary and secondary endpoints,
✓ Optimises the feasibility and clinical impact of the study.
The aim is to turn your idea or collaboration into a high-quality, methodologically sound proposal with real benefits for clinical practice.
This step is carried out in close collaboration between the clinical investigator, the DONET leader and CZECRIN experts.
Validation by DONET
Each project is then reviewed by the DONET Sector Board, which:
✓ Evaluates the technical relevance, innovation and clinical benefit of the proposal,
✓ Provides a validation opinion on the project that confirms the professional support for the medical field,
✓ may recommend additions, extensions or modifications to the proposal.
Once approved, the project is included among the validated CZECRIN proposals, which allows the involvement of centres and partners interested in collaboration.
Allocation of CZECRIN expert support (open access)
On the basis of the validation, the study or its proposal may be assigned expert and methodological support from the CZECRIN infrastructure, including:
✓ Biostatistical expertise,
✓ medical writing, designing or finalizing the protocol,
✓ datamanagement and monitoring,
✓ regulatory advice and pharmacovigilance,
✓ project coordination and methodological guidance.
The allocation of these capacities is decided by the CZECRIN Evaluation Committee according to the principles of open access – i.e. transparent and equal access for all applicants.
Project preparation and implementation
After the approval of the support, the research team together with CZECRIN experts focuses on:
✓ finalisation of the protocol and study documentation,
✓ preparation of documentation for review by the Ethics Committee and the Regulatory Authority,
✓ planning and coordination of the centres involved,
✓ and support system setup (monitoring, datamanagement, project management…).
The aim is that each project should be methodologically sound, feasible and have a concrete impact on patient care and clinical practice.
Do you have a research project or clinical question?
The first step is the form – we’ll go through the rest with you.