Clinical Trials Committee

The ACT Health Clinical Trials Committee (CTC) is responsible for the review and authorisation of clinical trials, registry projects and biobanks conducted at or by ACT Health.

Definitions:

Clinical Trial – Clinical research where a therapeutic intervention in human subjects is being evaluated

Registry – Clinical registry where use of data for research is a current or future intention

Biobank – Collection and storage of biological samples for research purposes. Storage may be local (ACT Health) or external

CTC Terms of Reference

CTC Membership 2018

CTC Meeting and submission dates 2018

CTC Review Process:

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:

  1. Feasibility Assessment Clinical Trial or Feasibility Assessment Registry
  2. Governance Clearance Sheet Clinical Trial or Governance Clearance Sheet Registry
  3. Special Purpose Account report (for ACT Health areas only)
  4. Plain language summary of the trial or registry (to be provided by the principal researcher)
  5. Clinical trial or registry protocol or protocol synopsis

Please submit all items to research.governance@act.gov.au

Step Two Requirements for review:

Step two of the process includes proceeding with budget negotiations and usual ethics/site governance review.

Ethics and site governance review information

Once budget negotiations are final submit the final research agreement and finance summary for review and authorisation. 

Please submit to research.governance@act.gov.au

For any queries please contact the committee secretariat on 02 6174 7968.