- Pharma Contract Templates
- MedTech Contract Templates
- Costing Tool
- Standardised Indemnity
- Decentralised Clinical Trials SOPs
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.
Collaborative or Cooperative Groups
Contract Addendum Template
Site Personnel Privacy Consent – optional use
CTRA Indemnity Te Whatu Ora Guidance
Updates to the CIRA’s
The standardised Clinical Investigation Research Agreement (sCIRA) have been updated for alignment with the Privacy Act 2020.
Updates to the CIRA’s
- In March 2021, the standardised Clinical Investigation Research Agreement (sCIRA) have been updated for alignment with the Privacy Act 2020.
- The Sponsor and CRO sCIRA’s were updated in June 2021 to remove the reference to the Medicines New Zealand Guidelines on Clinical Trials Compensation for Injury Resulting From Participation in an Industry-Sponsored Clinical Trial in relation to participant compensation for Medical Technology studies.
Collaborative or Cooperative Groups
CIRA Addendum Template
Privacy Consent – for optional use
Costing Tool
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.
The costing tool is an Excel spreadsheet template that can be used by sites to facilitate accurate trial costing and to support transparent price discussion.
Download here:
NZ Clinical Research costing tool v1.4 Mar 2017 (109 KB)
NZ Clinical Research costing tool Summary of Changes v1.4 Mar 2017 (210 KB)
Why was it created?
The idea for the costing tool arose in 2013 when a group of DHB Clinical Research Management and Finance staff formed a working group to share their knowledge of site costing for clinical trials. The aim of the group was to help give substance to the Government’s earlier recommendations for streamlining clinical trials in New Zealand by designing a transferrable and standardised clinical trial costing guidance tool for use in DHBs and other clinical trial sites. Members of the working group have practical experience in developing budgets to ensure the costs of carrying out commercial clinical research in their organisation are fully covered, and a wide knowledge and understanding of the political and process context of the clinical trial environment at both an organisational and national level. In addition, a number of Sponsor and CRO representatives very kindly provided feedback during the development phase of the tool. We greatly appreciate their generous help and advice. [i] Government Response to the Report of the Health Committee on its Inquiry into improving New Zealand’s environment to support innovation through clinical trials
What types of trial can I use the tool for?
The tool was developed to cost site participation in interventional commercial clinical trials, however it can be adapted by the user for non-commercial clinical trials. It does not include sponsor-related or trial centre management costs such as database building, CRF creation, statistical analysis or monitoring.
How does the tool add value?
The aim of the tool is to provide a resource that:
- provides all parties in the clinical trials industry with a clear and consistent understanding of what the various components and terms involved in costing for clinical trials mean
- gives research teams and their organisations a clear and accurate picture of the financial implications of conducting a trial so that decisions can be made based on sound information
- gives consistency to the trial costing exercise, and improves efficiency as sites become familiar with the tool and can cost studies faster and more accurately
- provides a baseline against which actual trial costs can be compared as the trial runs to completion
- speeds up the budget negotiation process by ensuring all site costs are calculated at the outset, and site costs are consistent from one trial to the next
- is sufficiently uncomplicated (despite the complexity of clinical trial costing) that it can be used by busy research teams whether or not there is dedicated assistance and support within the organisation
- includes a summary of costs page that can be used during the site approval/signing stage
It is not a compulsory instrument; it is intended as a helpful tool which will streamline site budgeting processes and provide a common financial ‘language’ for clinical trial costing. Also, it is not intended that the costing tool replaces sponsor-site budget discussions and negotiations. It is an in-house document only which will allow sites to see where their costs lie.
How is it maintained?
The tool was released as a beta version in Jan 2015, and finalised in Dec 2015. Periodic updates and improvements will continue to be made to the tool by the working party. Comments, queries and feedback about the tool can be sent to info@nzacres.org.nz The NZACRes costing tool has been developed to facilitate accurate trial costing and to support transparent price discussion. Although every effort has been taken to ensure the tool is accurate, NZACRes does not assume any liability from the use of the tool.
How do I use the costing tool?
Users do need to have a degree of familiarity with excel spreadsheets. If you are not a moderately confident spreadsheet user, it will be necessary to access some support. The costing tool might look frighteningly complex when you first look at it. This is because we have tried to cover every eventuality and cost for as many types of trials as we could think of. However, although the costing tool covers an extensive range of items, not all of these will be appropriate for every trial and you will need to pick and choose what is relevant for the trial you are working on. As you work your way through it, you will be able to match the requirements of your protocol to the items.
Instructions for use
There is a set of instructions on the first tab which we suggest you print off, quickly scan through and then keep alongside you as you work through the spreadsheet. These instructions provide a succinct account of the purpose of each tab, instructions and things to take into consideration when using the tab. Each tab deals with a different set of costs and all costs are arranged so that they are counted only once.
Study Protocol
In preparation you will need to have a good understanding of the protocol and be in a position to start building up a true knowledge of the costs your organisation would charge for each item. It is your organisation’s decision whether an item is something that you need reimbursement for or whether your organisation is prepared to carry that cost. However, this costing tool will help make that clear because you can add your own clarifying comments into the sheet.
Evidence of costs
Good practice would suggest that each item has some ‘evidence’ to back up the amount that is filled in. While the working group would like to have put in guidelines about standard costs, in fact, there are no standard costs; each site has its own cost structures for various reasons. In addition, with the tendency for costs to change over time, the work involved in keeping the costing tool up to date would render it obsolete within a short time. Different organisations will have different ways of providing confirmation of costs and ideally there should be some sort of ‘paper trail’ which can be appended to the completed costing tool to show that the right people have been consulted about what items cost and that the costs they have provided are transferred to the costing tool.
Support and guidance
We would encourage you to develop your understanding of the costing tool, and the underlying costing requirements of your organisation, within your own community of practice. It is recommended that thought be given to what kinds of support and guidance might be made available at an institutional level as this is a really important factor in getting buy-in and having people feel comfortable about giving it a go.
Standardised Indemnity & Compensation Agreements (sICA)
After consultation with Pharmaceutical companies, CROs, DHBs and Universities, a standard Indemnity and Compensation Agreement (sICA) was created and released in November 2009. The sICA has been updated since initial release.
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.
Cancer Decentralised Clinical Trial (DCT) methodology
Clinical trials are essential to improving outcomes for patients with cancer. Opportunities for participation in clinical trials across Aotearoa New Zealand are inequitable, particularly for whānau living outside of major centres and for Māori and Pasifika. The implementation of decentralised clinical trials aims to increase access to clinical trials for people with cancer living across Aotearoa New Zealand. In the decentralised clinical trial model the primary trial site(s) work collaboratively with sites in smaller centres and rural areas (satellite sites) to enrol, consent and treat patients for the trial. Decentralised clinical trials essentially aim to increase access to clinical trials by decentralising the processes of a clinical trial. This can include consent, randomisation, delivery of investigational products, trial activity, data entry and potentially trial monitoring. Decentralised clinical trials give patients and whānau the opportunity to participate in clinical trials without the requirement for travel, which comes at a financial cost to both patients and the healthcare system. It also allows patients to continue to receive care locally (which can be in person), without removing them from their whānau and support systems. This makes trials more inclusive, accessible and whānau-centred.
The National Oncology Decentralised Clinical Trial Steering Committee, with financial support from Te Aho o Te Kahu, has overseen the development of processes and procedures and ensured that the development of decentralised clinical trial methodology is appropriate and relevant for whānau Māori and Aotearoa New Zealand.
The following documents (SOPs, supervision plan, terms of reference) have been developed by and are the responsibility of the National Oncology Decentralised Clinical Trial Steering Committee, not NZACRes. Any queries should be directed to the National Oncology Decentralised Clinical Trial Steering Committee co-lead Dr Nicky Lawrence: nicky.lawrence@auckland.ac.nz