Clinical Trial Application Process

Grant Application Process

Locality Authorisation Process

The purpose of a CDA is to ensure sensitive information exchanged between parties is protected.  In the context of a clinical trial, or other research project, a CDA with a Sponsor places confidentiality obligations on the CDHB with regards to the use and distribution of that information. These obligations must be adhered to, as any breach may potentially have significant consequences.

Master CDAs have been agreed with the following Sponsors. A Master CDA will cover information provided by a sponsor relating to its clinical trials for a specified period of time, and avoids the need for an individual CDA to be completed for each specific study.

Please contact legal if you have any questions. Email: legal.services@cdhb.health.nz

Registering your project sets in motion a request for services. There are 4 main options:

1. Pre-Feasibility registration – registering a Commercial Trial at pre-feasibility stage.
2. Memorandum of Understandings (MOUs) – requesting an MOU between an external organisation and Canterbury DHB.
3. Locality Authorisation only – solely applying for Locality Authorisation to undertake research using CDHB resources eg. Non CDHB-hosted clinical trial.
4. Grant application – requesting assistance with all aspects of grant applications.
5. Clinical Trial – registering CDHB-hosted commercial or other collaborative clinical trials.

Register your project

The following costings tools and templates will help you work out your project budget.

Costing worksheets

Locality Costings Worksheet (LCW) for CDHB-hosted clinical trials

Costings & Consent Worksheet (CCW) for grants

Standards fees and price lists

CDHB standard price list for procedure and start-up costs

CDHB Pharmacy pricing schedule

Pacific Radiology Group (PRG) fees

Requests for rates and quotes

Employee hourly rates – please contact the Research Office to request the calculation tool

Laboratory costs – complete the CHL quotation form and send to CHLResearch@cdhb.health.nz 

Pharmacy costs – email pharmacyclinicaltrials@cdhb.health.nz to request a quote as early as possible     

Pacific Radiology costs – complete the PRG Research Application form and send to research@prg.co.nz 

This Memorandum of Understanding (MOU) template is for anyone doing CDHB-hosted research who requires an MOU between the CDHB and an external organisation.

It is important that you start the MOU process as early as possible so that accurate costings can be obtained.

An accurate and detailed MOU will reduce the potential for delays at sign-off stage and expedite the subsequent subcontract process.

This section provides information about the available contracting templates and legal resources to assist with research applications.

Please note that most links below are only accessible to CDHB staff.

Commercial and CDHB-hosted clinical trials

The CDHB has some Master Clinical Trial Research Agreement (CTRA) templates with individual sponsors. The Research Office will supply you with the appropriate CTRA if relevant.

Otherwise, please use the following standard CDHB templates:

• Sponsor CTRA template – for sponsor funded clinical trials
• Clinical Research Organisation (CRO) CTRA template – for CRO funded clinical trials
• Collaborative CTRA template – for CDHB-hosted clinical trials in collaboration with other institutions

Clinical Trial FAQ’s

Grant-funded research

If a grant research application has been successful, the funder will provide a contract to the Principal Investigator directly or via the Research Office.

Subcontracts with external parties

Please use the following templates when sub-contracting to an external party for CDHB-hosted research.

• CDHB subcontracts - please contact the Research Office
• CDHB/University of Otago subcontract template – please contact the Research Office
• CDHB subcontract addendum template

Legal resources for commercial clinical trial research contracts

Please refer to the legal advice below regarding standard legal text and letters to be used for Clinical Research.

• Standard wording to add in contracts with sponsors/organisations to explain CDHB’s longstop and GST special conditions (100KB, PDF)
• CDHB Finance Approved GST-zero rated clause for New Zealand Association of Clinical Research (NZACRes) CTRA  – clause for Schedule 2 (100KB, PDF)
• Requirement to contract on the New Zealand Association of Clinical Research standard agreements – legal letter (150KB, PDF)
• Insurance Cover for Commercial Clinical Research Studies – legal letter (150KB, PDF)

If you have any questions about any contracts or subcontracts, please contact the Research Office

For contract amendments which only involve changes to address, title, PI name, sponsor name etc, please use the NEW simplified amendment form .

For other CDHB Clinical Trial contract amendments, please update a copy of your last signed Locality Costing Worksheet (LCW) using a different colour font to identify changes.

Submit either of the above to the Research Office along with the new amendment contract.

You will require a Locality Authorisation to undertake a research project within the CDHB if you are:

• Recruiting CDHB patients
• Collaborating with CDHB staff
• Using CDHB clinics or staff
• Accessing data held by the CDHB or patient records
• Using facilities, buildings or space of the CDHB

Work is underway to stratify locality authorisation into different categories of risk which will follow different approval pathways. Completing the registration form will link you to the correct pathway. 

Register your project

CDHB-hosted grant studies only – please contact the Research Office directly for the correct form.

Want to share your research progress or results with colleagues or the wider public? Contact the Canterbury DHB Corporate Communications Team at communications@cdhb.health.nz to get your story heard.

The team produces the internal CDHB staff newsletter CEO Update, which is also shared with wider health and regional stakeholders and media. The team can also assist with media releases and media pitching.

Translating research into practice

One of the aims of the Canterbury Health System Research Strategy 2020-25 (350KB, PDF) is for more research to be converted into clinical practice and directly impact health service delivery. There is work underway to establish a governance structure that will look at ways to enable changes to clinical practice.

The CDHB Research Office is co-located with the University of Otago, Christchurch Research Office.

Appointments with Advisors

• Please email researchoffice@otago.ac.nz to book a time to talk to an advisor between Monday–Friday 9am-4.30pm pending availability 
• Please include the project, topic or advisor you wish to meet and your preferred days/times.

Drop-in times 

For a quick chat with one of the team the office keeps one-hour per day open for drop-ins. Find us in Room 520, Level 5, University of Otago, Christchurch building at Christchurch Hospital Campus.

The Canterbury Health System vision is to promote research which supports our service delivery to enhance the health and wellbeing of our community – by informing decisions and changes to policy, practice or systems. The transalpine Canterbury and West Coast partnership aims to be a leader in health system implementation research and knowledge transfer which improves the health and wellbeing of our population and which leads to equitable outcomes for our people and across our geography.

Please read our Canterbury and West Coast Health System Research Strategy 2020-25 (350KB, PDF)

A new research governance group is being established and will have oversight of research throughout Canterbury DHB and set policy and priorities for future research activities.

Research Office key partner organisations.

• University of Otago, Christchurch
• University of Canterbury
• Ara Institute of Canterbury
• Ngāi Tahu
• Manawhenua Ki Waitaha Charitable Trust
• Canterbury Medical Research Foundation
• Canterbury Clinical Studies Trust