The Sponsor-Investigator fulfils the responsibilities of both Sponsor and Investigator as per the TGA: ICH Guideline for Good Clinical Practice (GCP).

The functions of the Sponsor-Investigator, specifically for investigator-initiated trials, include:

  • Securing funding for the clinical trial
  • Generating clinical trial documentation, such as informed consent, protocols, as well as submissions, for example, ethics and/or regulatory submissions
  • Ensuring adequate resources are available for the duration of the trial, such as experienced staff, investigational products, clinical and medical supplies, central laboratory
  • Creating appropriate written procedures, such as standard operating procedures (SOPs), related to Good Clinical Practice (GCP)
  • Meeting all the applicable regulatory requirements such as obtaining and maintaining necessary approvals from the relevant ethics committees and regulatory agencies
  • Managing essential documents using a Trial Master File (TMF)
  • Acknowledging those who have contributed to the clinical trial, and cite and acknowledge other relevant work appropriately and accurately
  • Participating in peer review in a way that is fair, rigorous and timely and maintains the confidentiality of the content
  • Adopting methods appropriate to the aims of the clinical trial and ensure that conclusions are justified by the results
  • Disseminating clinical trial findings responsibly, accurately and broadly. Where necessary, take action to correct the record in a timely manner
  • Ensuring that authors of clinical trial outputs are all those, and only those, who have made a significant intellectual or scholarly contribution to the clinical trial and its output, and that they agree to be listed as an author