New Zealand

DCT Feasibility Assessment New Zealand The below version control table serves to document all updates made to the guidebook. The purpose is to ensure the information is always accurate and up-to-date. Disclaime...

This guidebook provides an overview of the current regulatory landscape in New Zealand in relation to Decentralized Clinical Trials (“DCT”). New Zealand abides by the regulations set forth by the New Zealand Medicines and Medical Devices Safety ...

2.1 Name of Regulatory Authority Health Research Council (HRC) - http://www.hrc.govt.nz/ Section 30 of the Medicines Act authorizes the Director-General of Health to approve a clinical trial involving the use of new and unregistered medici...

3.1 Provide a list of documents needed to be submitted for EC/IRB review and approval including the number of copies and/or translations as relevant.   To complete the application, applicants will need to create an account and log in to the...

4.1 Provide a list of documents needed to be submitted for RA/CA review and approval including the number of copies and/or translations as relevant.  Details of the documents required by Medsafe are linked here . Specific to Clinical Tr...

5.1 Does local regulation require PI/CI to be approved/registered by any health authority (e.g., RA/EC)?   No , not specifically. The principal investigator must be a resident of New Zealand. All investigators must have New Zealand-recogn...

6.1 Provide a list of documents needed for export permit relevant to biological specimen shipment. The requirements in relation to the handling and shipping of biological samples from decentralized clinical trials are described in a Standard Op...

7.1  Do the country regulations allow Decentralized Clinical Trials (DCT) elements (e.g., eConsent, ePRO administration, remote investigator site, etc.)? Yes . In principle, there is nothing to prevent the implementation of a DCT model i...

8.1 What data privacy and/or technology regulations need to be complied with to run a trial in the countries of interest?   Health Information, including practices relating to the management of data from clinical trials, is governed by the H...

9.1 Clinical trial subject recruitment: Are digital advertisements (including social media streams such as TikTok) allowed and, if so, what regulations govern them ?   HDEC must review the methods and material that investigators propose ...

10.1 Clinical Trial with Investigational Medicinal Product Section 30 of the Medicines Act requires that the Director-General of Health must approve clinical trials involving new medicines. This requirement applies to all types of clinical tr...

Health Research Council New Zealand (HRCNZ) (n.d.) Home Page ,  HRCNZ, accessed November 2022 Manatu Hauora Ministry of Health (n.d.) Popular Topics ,  Manatu Hauora, accessed November 2022 HDECs (Health and Disability Ethics Co...

MEDSAFE forms https://www.medsafe.govt.nz/regulatory/forms.asp Clinical Trial Site Notification https://www.medsafe.govt.nz/regulatory/Guideline/GRTPNZ/Clinical%20Trial%20Site%20Notification%20Form.pdf Link to Online Application Form&nb...