Responsibilities and Services
The requirements for clinical studies, which are legally regulated, are complex and extensive and require dedicated time for administrative and coordinative handling.
The CTC-A serves as a central point of contact for involved project partners in the self-initiated research of the interdisciplinary and multi-professional project teams. It is also the contact for external offices such as ethics committees, agencies, and finaciers.
All relevant aspects of clinical examination are identified, recorded, and prepared for a successful approval processes among ethics committies and agencies within a timely fashion in accordance with the AMG, MPG, or BOÄ. The CTC-A ensures that there is appropriate, overarching communication between all the involved institutions and partners.
Support for researchers in individual and needs-based. All services with costs are available individually.
| Basic Services – free up to 54 hours | Services – for a fee* |
|---|---|
| Full cost calculation (Industry and IIT) | Creation of a study protocol |
| Contract review | Requests for insurance |
| Entry into the register of clinical trials www.clinicaltrials.gov |
Proposals to ethics committees and agencies |
| Support with funding proposals | Project management |
| General clinical trial advising | Integrative management & correspondence |
| Budget management | Monitoring/Audit |
| Creation of documents | |
| Creation of annual reports | |
| Management of unwanted events | |
| Flying Study Nurse | |
| Data management |