The successful implementation of clinical study projects requires thorough planning and preparation. The central task in the Clinical Trial Consulting unit is to assist in scientific questions concerning drug trials, medical devices trials and biomedical research projects.
In a non-committal initial interview, clinical and medical as well as methodological and regulatory aspects are discussed. The clinician will thus gain a clear picture of the trial-related responsibilities accompanying the planned project.
The planning of methodical aspects is carried out in close consultation with the Institute of Biostatistics and Clinical Research (IBKF).
In the course of the counselling interview, special emphasis is placed on the topics of potential sponsorship by UKM, funding, contracting, procedural questions about settling accounts for the research project and support in submitting grant applications, in particular DFG, BMBF and EU applications.
The Centre for Clinical Trials provides assistance in the following areas:
- Project consultation
- Settling the question of sponsorship
- Advice on regulatory issues
- Proposal compilation (setting out basic clinical and methodical issues)
- Defining parameters
- Negotiating responsibilities and liabilities
- Coordination of performance requirements
- Planning of time frame
- Financial planning
- Assistance in grant applications (DFG, BMBF, EU programmes)
- Negotiations with commercial partners
- Contractual arrangements regarding methodology and funding