Endorsed Study Model
The AGITG encourages investigators to submit concepts requiring ‘endorsement’ or ‘sponsorship’ for consideration via the internal processes in place.
Concepts that are ‘endorsed’ may involve AGITG liaising with the sponsoring institution to:
- Conduct feasibility to gauge interest from a wide network of potential sites to participate in the study;
- Advertise the study on the AGITG website;
- Invite presentations at the ASM;
- CAP review and feedback: lay summary of concept and master Participant Information Sheet and Consent Form.
Investigators requesting AGITG endorsement of concepts must agree to the following governance framework:
- AGITG Working Party reviews and approves the scientific merit of the research proposals. Investigators should advise of any time sensitivities in relation to Working Party review.
- AGITG Consumer Advisory Panel reviews the relevance of the concept from a consumer perspective.
- AGITG-CTC Operations Executive reviews and approves the resources allocated to conduct the study including the study budget.
- A TMC will be appointed to maintain adequate oversight on the trial if necesary.
- An AGITG Member is an Investigator on the study.
- The Institution submits six-monthly progress reports using the AGITG reporting template in a timely manner. In addition, the relevant AGITG Working Party throughout the year may request study update.
- If the pilot research develops a positive signal that warrants a larger-scale study:
a) AGITG will have the expectation to review and act as Sponsor of the study, and the Chief Investigator and AGITG will work together to source additional grant or industry funding. A Coordinating Centre selected by the AGITG will coordinate the large-scale study.
b) AGITG will request access to the pilot study data for the purposes of developing a larger-scale study.
- AGITG will be acknowledged in all publications arising from the pilot study to reflect the support provided to the investigator.
- Execution of an agreement including the above terms.
Endorsed Study Approval Mechanism