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for Injury Resulting from Participation in an Industry Sponsored Clinical Trial" referenced in the sCTRA is no longer active.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. 

Sponsor

NZACRes sCTRA, Sponsor, V5, 3 Oct 2016 NZACRes sCTRA, Sponsor, V5, 3 Oct 2016 (73 KB)

NZACRes sCTRA, Sponsor, V5, 3 Oct 2016 - track changes.doc NZACRes sCTRA, Sponsor, V5, 3 Oct 2016 - track changes.doc (242 KB)

CRO

NZACRes CRO CTRA, V3, 10 Oct 2016.docx NZACRes CRO CTRA, V3, 10 Oct 2016.docx (80 KB)

NZACRes CRO CTRA, V3, 10 Oct 2016 - track changes.doc NZACRes CRO CTRA, V3, 10 Oct 2016 - track changes.doc (278 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.   

Standardised Indemnity & Compensation Agreements (sCIA)

After consultation with many local Pharma companies, CROs, DHBs and Universities, a standard Indemnity and Compensation Agreement (sICA) was created and released in November 2009. Following feedback from industry the sICA has been modified slightly and has now been released as

NZ sICA Version 3 updated 28 July 2015 - Changes Highlighted NZ sICA Version 3 updated 28 July 2015 - Changes Highlighted (66 KB)

NZ sICA Version 3 updated 28 July 2015 - Clean copy NZ sICA Version 3 updated 28 July 2015 - Clean copy (64 KB)

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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