Clinical Trials Committee
The ACT Health Clinical Trials Committee (CTC) is responsible for the review and authorisation of clinical trials and registry projects conducted at or by ACT Health.
For the purposes of the CTC a clinical trial is described as:
“Clinical research where a therapeutic intervention in human subjects is being evaluated”
The CTC operates a two-step process as follows:
Step one: before any project commences the researcher and research unit must complete a feasibility assessment and submit to the CTC for an initial assessment.
Once feasibility has been confirmed the CTC will issue formal correspondence advising of the next steps in the process.
Step two: following completion of budget negotiations researchers’ must submit a final budget, finance summary* and research agreement to the CTC for authorisation.
*finance summary to be provided by Finance Office. Queries addressed to Karyn.Ward@act.gov.au
Step One Requirements for review:
The following items are to be submitted for initial feasibility review:
- Feasibility Assessment Clinical Trial or Feasibility Assessment Registry
- Governance Clearance Sheet Clinical Trial or Governance Clearance Sheet Registry
- Special Purpose Account report (for ACT Health areas only)
- Plain language summary of the trial or registry (to be provided by the principal researcher)
- Clinical trial or registry protocol or protocol synopsis
Please submit all items to firstname.lastname@example.org
Step Two Requirements for review:
Step two of the process includes proceeding with budget negotiations and usual ethics/site governance review.
Once budget negotiations are final submit the final research agreement and finance summary for review and authorisation.
Please submit to email@example.com
For any queries please contact the committee secretariat on 02 6174 7968.