Sponsor

A sponsor is an individual, organization or company that assumes the primary responsibility and management of a clinical trial. Often the sponsor is the manufacturer of the medical device or drug under investigation, but in Investigator Initiated Trial it may be a university institution, specialist clinic or medical practice.

A sponsor does not only take over the financing of a project, but since the 12th amendment of the AMG has numerous obligations such as:

• Organization of all processes
• Ensuring the good feasibility of the study
• Preparation of the study design and writing of the study plan or observation plan
• Official (submission to the ethics committee and application to the higher federal authorities (BOB)
• Preparation of the auditor information
• Provision of patient information and education
• Funding
• Cooperation with partners (Clinical Research Organisations - CRO)
• Selection of study centres
• Creation of CRF`s
• Provision of the investigational product / medicinal product
• Case number calculations and statistical analyses
• Publication of study results (in observational studies according to STROBE statement)
• Quality assurance (e.g. through monitoring)
• Reporting of Serious Adverse Events / SUSAR`s
• Preparation of a final study report in accordance with guidelines

If the sponsor cooperates with a contract research organisation (CRO), parts of the responsibilities can be transferred.

In Germany, the AMG states that there is one sponsor, whereas other countries have several sponsors by law. The WHO therefore distinguishes between primary and secondary sponsors.