Duties of a sponsor involved in a clinical study
- The sponsor is the person or organization who carries the responsibility for the investigation, organization and funding of a clinical investigation with humans or performance evaluations of in-vitro diagnostic medical devices.
- Before starting a clinical investigation, the sponsor notifies the competent authorities of the Member States in which the investigations shall be conducted. In case the sponsor is not located in the European Community, he nominates an Authorized Representative (EC Representative, EC Rep) located within the EU to take over its duties as required by the relevant directives and local laws of the EU member states in which the studies will be performed.
- During the clinical study, the sponsor or its Authorized Representative informs the relevant competent authorities about any severe adverse event observed.
- The sponsor or his Authorized Representative shall notify the competent authorities in the relevant member states concerned of the end of the clinical study, with a justification in case of early termination.
Before MedNet can act as your Authorized Representative, the manufacturer must complete the following steps:
- The product compliance must be ensured.
- The product must be classified.
- The sponsor must keep a liability insurance according to the laws of the individual countries where the study will take place.
- An agreement between manufacturer and MedNet has to be signed.