Medicines Australia

Medicines Australia represents the research-based prescription pharmaceuticals industry in Australia.

Medicines Australia Form of Indemnity

The Medicines Australia Form of Indemnity for clinical trials has been developed for use in Australia. It is the basis for agreements between commercial companies sponsoring clinical studies and the institution that hosts the study to be conducted. All companies must use this Form of Indemnity.

There are 2 versions:

1. Form of Indemnity - Standard
   For use where the Indemnified Party is providing premises for the conduct of the Study and HREC Review, or is providing premises only.
2. Form of Indemnity - HREC Review Only
   For use where the Indemnified Party is providing HREC review ONLY of the study.

Clinical Trial Research Agreement (CTRA)

The Standard Clinical Trial Research Agreement is an industry standard and approved by Medicines Australia and NSW Health as appropriate for commercially sponsored clinical trial research.

A second version of the CTRA has been developed for CRO’s which is to be used where a Contract Research Organisation acts as, and assumes all of the responsibilities of, a local sponsor.

The third version of the CTRA has been developed for Collaborative or Cooperative Research Group (CRG) studies where the CRG is an academic and/or non-commercial collaborative research group responsible for sponsoring, initiating, managing, developing and coordinating the Study.

If these Agreements are used in their unaltered form there should not be a requirement for further legal counsel review.

All three versions of the CTRA are available on the Medicines Australia website.