Pharma Contract Templates
Standardised Clinical Trials Research Agreements (sCTRA)
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.
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.
Updates to the CTRA’s
The standardised Clinical Trial Research Agreement (sCTRA) have been updated for alignment with the Privacy Act 2020.
Clinical Trial Agreements and Indemnity for commercial clinical trials
NZACRes has been made aware that Health NZ/Te Whatu Ora have implemented their own templates for clinical trial agreements and indemnity for commercial clinical trials, effective immediately. NZACRes has not been consulted on the content of these documents and is not responsible for the provision of support for the utilisation of the Health NZ templates. As these templates differ from the standard NZ templates provided by NZACRes, we strongly recommend that all parties conduct full legal review before use. NZACRes will continue to maintain the NZ standard templates and consult with the clinical trials community before implementing any amendments or changes.
Health NZ has provided an update regarding these templates as follows:
Health New Zealand I Te Whatu Ora is introducing a new Indemnity and Compensation Agreement template for use in commercial clinical trials.
The new template reflects the need for a consistent approach across Health NZ and updates the NZACRes Clinical Research Trials Agreement (CRTA) and Indemnity & Compensation Agreement (ICA).
The updates ensure that Health NZ can meet its obligations to trial participants under the Code of Health and Disability Services Consumers’ Rights.
The new Indemnity and Compensation Agreement clarifies that trial participants who suffer an adverse injury as a result of their participation in a commercial trial are entitled to at least ACC equivalent compensation. This entitlement is a condition of the Health and Disability Ethics Committee’s approval of commercial trials.
The associated Indemnity provisions in the CTRA templates for commercially sponsored clinical trials have been amended to reflect the new Health NZ Indemnity requirements.
Health NZ will begin using the new ICA and CTRA templates immediately replacing current NZACRes templates for commercial trials. The new Health NZ CTRA Sponsor, CRO and ICA documents are available from Health NZ site legal teams.
SPONSOR
NZACRes, Sponsor CTRA
SPONSOR Guidance Document
NZACRes, CRO CTRA Guidance Document
CRO
NZACRes, CRO CTRA
CRO Guidance Document
NZACRes, CRO CTRA Guidance Document
COLLABORATIVE OR COOPERATIVE GROUPS
NZACRes, CRG CTRA
COLLABORATIVE OR COOPERATIVE GROUPS Guidance Document
NZACRes, CRG CTRAGuidanceDocument
CONTRACT ADDENUM TEMPLATE
NZACRes Addendum Template
SITE PERSONAL PRIVACY CONSENT - OPTIONAL USE
Privacy Consent
CTRA INDEMNITY TE WHATU ORA GUIDANCE
CTRA Indemnity Te Whatu Ora Guidance