| Sponsor | Sponsor |
| According to ICH-GCP, the sponsor is any natural person or corporate entity that is responsible for the funding and the conduct of a clinical trial. ISO-14155 states that the sponsor is an individual or organization taking responsibility and liability for the initiation or implementation of a clinical investigation.
According to both ICH-GCP and ISO-14155, an investigator can act as the sponsor if they initiate and conducts a clinical trial and takes the responsibility for it. Such trials are frequently called non-commercial, investigator-initiated, science-driven, or academic. The regular responsibilities of the sponsor in commercial and non-commercial trials are the selection of suitable staff (internal as well as external – such as service providers and appropriate study sites), quality monitoring during the conduct of the trial by means of monitoring and audits and safeguarding the proper conduct. |
Deutsche Erklärung |
