EXPRESSION OF INTEREST TO CONDUCT A CLINICAL STUDY
AusCann Group Holdings Ltd, and its wholly owned subsidiary AusCann Operations Pty Ltd (together called “the Company”), are committed to the support of relevant, quality studies for the generation of clinical evidence, in the area of cannabinoid-based therapeutics. Interested investigators/sites may respond by completing this standard form. Responses are used by the Company to facilitate more detailed feasibility discussions with the interested investigator/sites, and at this time additional proposed study information will be shared under non-disclosure agreement.
- AusCann accepts concept submissions and full submissions for Investigator-Initiated Studies (IIS). If a concept submission is of interest a follow-up discussion and progression to a full submission will occur.
- AusCann will not support the following:
- Requests for support for ongoing studies or new research without an associated study
synopsis; - Compassionate supply requests (should be directed to the Company outside this process);
- General educational and training activities;
- Start-up funds to establish new clinical or research programs or to expand existing programs;
- Purchase of capital equipment or any equipment unrelated to the study or which could be used
to generate revenue; - Construction, refit or maintenance costs associated with a facility;
- Hiring of staff and staff costs unless they are dedicated to the study, and then only for the
duration of the study.
- Requests for support for ongoing studies or new research without an associated study
- Note: If the clinical study is approved for support, AusCann will require:
- HREC/ethics/IRB approval and any subsequent study notifications from the committee;
- Final study protocol and any updates;
- Regulatory documentation (including CTN/CTX if applicable);
- Fully executed IIS agreement.