Consulting

ZKS Jena offers free-of-cost advice on organizational, regulatory, methodological and financial aspects of clinical studies to all potential principal investigators from Jena University Hospital (see consulting process). Focus areas are:

• tasks and responsibilities associated with GCP and legal framework conditions
• sponsor responsibilities in AMG (German drug law), MPG (medical devices act) and publicly funded studies
• study methodology/study design
• feasibility assessment: preliminary estimation of case numbers, budget relevant issues, necessary cooperations
• For your first consultation (contact person Isabella Schiller), please prepare:
  • a synopsis or short outline (use the BMBF/DFG Skizzentemplate  if possible)
  • ideas on the financing
  • literature research (key publications)
  • preliminary data for case number estimation

During the consultation a convincing outline of the study will be prepared in close collaboration. Further cooperation with ZKS Jena is possible (Studienbetreuung). In that case, tasks and responsibilities will be set out in a cooperation agreement.