Clinical Trials Research Agreements
The following Medicines Australia Clinical Trial Research Agreements and Forms of Indemnity have been revised and new versions are now available below:
The 16 November 2012 versions of the Clinical Trials Research Agreement are now available below.
- Clinical Trial Research Agreement – Medicines Australia Standard Form 159k
- Clinical Trial Research Agreement – CTRA: Contract Research Organisation acting as the Local Sponsor 144k
- Clinical Trial Research Agreement – Collaborative or Cooperative Research Group (CRG) Studies 155k
- Clinical Trial Research Agreement – Phase 4 Clinical Trial (Medicines) 143k
Please note: The four Clinical Trial Research Agreements are now available as unlocked Word 97-2003 documents, with the agreement of colleagues in the Eastern States Health Departments. Therefore, in using the standard CTRAs note in particular that: “Any textual change to the body of this Agreement is to be ignored, and reference instead had to the standard form, as amended by Schedule 7 (or Schedule 4) by way of Special Conditions”.
The CTRAs were amended following the identification of some errors in the documents. In particular the Term and Termination clause 13.9 incorrectly listed certain clauses that should survive termination and omitted other clauses. In once again reviewing the documents other minor inconsistencies of wording and terminology were also identified, which have been corrected. The previous documents included a number of ‘field codes’, which contributed to the errors that were found in the October 2012 documents. All field codes have been removed from the 16 November 2012 documents.