Sponsor

Author:Prof. Dr. med. Peter Altmeyer

All authors of this article

Last updated on: 29.10.2020

Dieser Artikel auf Deutsch

Requires free registration (medical professionals only)

Please login to access all articles, images, and functions.

Our content is available exclusively to medical professionals. If you have already registered, please login. If you haven't, you can register for free (medical professionals only).


Requires free registration (medical professionals only)

Please complete your registration to access all articles and images.

To gain access, you must complete your registration. You either haven't confirmed your e-mail address or we still need proof that you are a member of the medical profession.

Finish your registration now

DefinitionThis section has been translated automatically.

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.

General informationThis section has been translated automatically.

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.

Authors

Last updated on: 29.10.2020