Approving authorities are public or private legal entities (institutions or organisations) where trials are conducted.
Approving authorities conducting trials under the CTX and CTN schemes have specific responsibilities as outlined in:
For investigator-initiated trials and registry trials the health service organisation or trial site that is the approving authority may also be the trial sponsor or institutional sponsor. In such cases the governing body ensures that its overarching governance and quality management systems delineate its responsibilities as a trial sponsor from its responsibilities as a trial site and ensures that the requirements of sponsorship are able to be met.
