Contract Templates

The New Zealand Association of Clinical Research (NZACRes) has developed a standardised Clinical Trial Research Agreement (sCTRA) based on the Medicines Australia template that has successfully been used in Australia. More recently NZACRes has consulted widely with the New Zealand clinical research industry to update the standardised Clinical Trial Research Agreement. 

Standardised Clinical Trials Research Agreements (sCTRA)  

Note: The link to the "Medicines New Zealand Guidelines on Clinical Trials Compensation for Injury Resulting from Participation in an Industry Sponsored Clinical Trial" referenced in the sCTRA is no longer active. Please refer directly to the Medicines NZ website.

8 August 2017 Minor updates have been made to the CRO and sponsor contract template to correct formatting issues.  These changes do not impact the contract and therefore version numbering has not changed. 

Sponsor

NZACRes sCTRA Sponsor V5 3 Oct 2016 NZACRes sCTRA Sponsor V5 3 Oct 2016 (184 KB)

NZACRes sCTRA Sponsor V5 3 Oct 2016 - track changes NZACRes sCTRA Sponsor V5 3 Oct 2016 - track changes (234 KB)

CRO

NZACRes CRO CTRA V3 10 Oct 2016 NZACRes CRO CTRA V3 10 Oct 2016 (202 KB)

NZACRes CRO CTRA V3 10 Oct 2016 - track changes NZACRes CRO CTRA V3 10 Oct 2016 - track changes (270 KB)

Important Notice CRO acting as Local Sponsor dated 29 July 2014
     
Collaborative or Cooperative Groups

NZACRes CRG CTRA, v2, 15 Oct 2016 NZACRes CRG CTRA, v2, 15 Oct 2016 (69 KB)

NZACRes CRG CTRA, v2, 15 Oct 2016 - track changes NZACRes CRG CTRA, v2, 15 Oct 2016 - track changes (240 KB)

Contract Addendum Template

NZACRes Addendum Template, v2, 23Sep2016 NZACRes Addendum Template, v2, 23Sep2016 (58 KB)

NZACRes Addendum Template, v2, 23Sep2016 - track changes NZACRes Addendum Template, v2, 23Sep2016 - track changes (36 KB)

Privacy Consent - for optional use

Privacy Consent, v1, 21Sep2016 Privacy Consent, v1, 21Sep2016 (23 KB)

Supporting Documents

NZACRes sCTRA, Sponsor Guidance Document, v5, 03 Oct 2016 NZACRes sCTRA, Sponsor Guidance Document, v5, 03 Oct 2016 (74 KB)

NZACRes sCTRA ,Sponsor, review explanatory document, 03 Oct 2016 NZACRes sCTRA ,Sponsor, review explanatory document, 03 Oct 2016 (52 KB)

NZACRes CRO CTRA, Guidance Document, v3, 10 Oct 2016 NZACRes CRO CTRA, Guidance Document, v3, 10 Oct 2016 (76 KB)

NZACRes CRO CTRA, review explanatory document, 10 Oct 2016 NZACRes CRO CTRA, review explanatory document, 10 Oct 2016 (48 KB)

NZACRes CRG CTRA, Guidance Document, v2, 15 Oct 2016 NZACRes CRG CTRA, Guidance Document, v2, 15 Oct 2016 (77 KB)

NZACRes sCTRA ,CRG, review explanatory document 15 Oct 2016 NZACRes sCTRA ,CRG, review explanatory document 15 Oct 2016 (46 KB)

NZACRes understands the need for organisations to review and plan for the implementation of the updated standard contracts.  During this period you may agree with your contracting party to use either the previous or updated version.  NZACRes suggests the updated version is used solely as of 1st July 2017.

NZACRes aims to assist members and the NZL research community by providing standard templates and tools.  In providing standard templates and tools NZACRes accepts no liability for any disputes arising from the use of these documents.   

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