New Zealand trials of new medicines need Medsafe approval on the advice of the SCOTT committee and a separate Health and Disability Ethics Committee approval. Capture gives New Zealand sponsors and investigators an EDC, ePRO and eConsent with an audit trail, hosted in the EU (Frankfurt) or the USA.
Free sandbox · No credit card · 21 CFR Part 11 aligned
Study region
New Zealand
Key points for studies in New Zealand
Regulation
Guidance on the New Zealand route describes affirmative pre-commencement approval for trials of new medicines: the Director-General of Health's authority to approve clinical trials is delegated to Medsafe, and SCOTT, a standing committee of the Health Research Council, reviews applications and makes recommendations. Medsafe notifies the applicant of the decision, and the approval letter also serves as customs clearance for importing an investigational product. If a trial is not approved, reasons are provided and the applicant can appeal under section 88 of the Medicines Act 1981. Gene and biotechnology trials go to a different committee.
Ethics review is separate. HDEC approval is required for clinical trials run in New Zealand, and applicants must show that the protocol and participant materials are consistent with privacy law. Study teams such as research institutes typically give participants an HDEC-approved participant information sheet and consent form before enrolment, so the version control of that document is the part your data system must get right. Details have moved over time, so check current Medsafe and HDEC guidance, and local counsel, before submission.
Because the New Zealand regime does not use CTIS, there is no single EU-style dossier to prepare. What both bodies share is an interest in the protocol, the consent text and the safety arrangements, and an inspector may later ask for records that show the study ran as approved. Capture exports a blank eCRF PDF (cover page, form index, visit-by-form matrix, every approved form printed empty) for submissions, and its audit trail is field-level and append-only, with user, timestamp, old value, new value and reason. For global studies that include New Zealand, the sponsor's overall regime may be the EU or US rules; see EU CTR clinical trial software and 21 CFR Part 11 compliant EDC.
Blank eCRF · no subject data
Visit by form matrix
| Form | SCR | D1 | W2 | W4 | W8 | EOS |
|---|---|---|---|---|---|---|
| Demographics | X | |||||
| Vital signs | X | X | X | X | X | X |
| Laboratory | X | X | X | |||
| ECG | X | X |
3. Was the ECG performed?
☐ Yes☐ No
If No, complete question 4.
At a glance
A simplified comparison to orient teams used to EU trials. Confirm everything with Medsafe, HDEC or local counsel.
| Topic | New Zealand | Impact on your study build |
|---|---|---|
| Submission portal | Medsafe application and HDEC online application | No CTIS dossier; prepare protocol, consent and forms for two bodies |
| Medicines approval | Medsafe, advised by SCOTT | Blank eCRF PDF and schedule of assessments for review |
| Ethics | HDEC, required for clinical trials | Consent version control matched to approved text |
| Privacy law | Privacy Act 2020 and Health Information Privacy Code 2020 | Document roles, access and offshore storage |
| Data location | No New Zealand region from Capture | Record the EU or US hosting choice in the privacy assessment |
| Global alignment | Often one arm of an international trial | One database across countries, site-level access |
Privacy
Health information in New Zealand is regulated by the Privacy Act 2020, and the Health Information Privacy Code 2020 modifies the information privacy principles for health agencies. Regulatory FAQs for sponsors point to the Code as governing how data from clinical trials is managed. The rules on disclosing personal information to an overseas recipient are part of the framework, and the Privacy Commissioner supervises. Whether and how a given hosting arrangement satisfies them depends on facts we cannot assess, so run it past your privacy officer.
The honest position on hosting is simple. Capture offers the EU (Frankfurt) and the USA (N. Virginia), chosen at study setup, and neither is in New Zealand. Many New Zealand institutions already use offshore research platforms, but some have policies on where identifiable health data may sit. The technical measures you can cite are AES-256 encryption at rest, TLS in transit, coded IDs for researchers, names visible only to site coordinators, and row-level security at the database layer. See data ownership and portability and GDPR compliant clinical trial software for the underlying controls.
Research involving Maori participants raises questions of data governance and partnership that go beyond statute, and HDEC and institutions may ask how you will handle them. This is a matter for consultation with the relevant communities and your institution, not something software settles. What a data system can do is keep access restricted by role and keep an auditable record of who saw what.
EU (Frankfurt)
Default for EU-sponsored studies
US (N. Virginia)
Default for US-sponsored studies
Consent
Capture's eConsent records the participant's on-screen signature with a one-time email code, then the investigator's countersignature with password re-authentication. The document is fully executed only after countersignature, and each signature is hashed to the exact document content at signing. Signed consent exports as a PDF with embedded signature data, timestamps and audit trail.
Meaning of signature
I have reviewed this adverse event and confirm the assessment of seriousness, severity and causality.
Signer
Dr. A. Ozola, PI
Password
••••••••••
Create the forms, export the blank eCRF and sign a test consent in the free sandbox.
Research setting
New Zealand clinical research is centred on the major university and hospital hubs in Auckland, Wellington, Christchurch and Dunedin, with a mix of industry-sponsored multinational studies, early-phase units and investigator-initiated work in areas such as respiratory medicine and diabetes. Many studies are one country arm of a trial that also runs in Australia, so a shared database across both makes sense; see clinical trial software in Australia. Time zones matter for diary-based work, since ePRO reminders and visit windows should be set in the participant's local time.
Small teams do not need an enterprise contract. Capture has no setup fee and no per-site fee; the sandbox contains every feature, and you pay only when you enrol real participants. See EDC for investigator-initiated trials, ePRO for patient-reported outcomes and the compare page against REDCap if you currently use a spreadsheet or REDCap.
Before you start
Medsafe and SCOTT for new-medicine trials; HDEC for ethics.
Electronic consent version control and signed PDF export tested.
Roles, access, offshore hosting and retention documented with your privacy officer.
EU (Frankfurt) or USA (N. Virginia), recorded in the data management plan.
Site-level access and training records.
For new medicines, approval is delegated to Medsafe on the recommendation of SCOTT. A Health and Disability Ethics Committee approves the ethics. Confirm current guidance on the Medsafe and HDEC sites.
No. New Zealand has its own approval route. The EU rules apply only to the EU parts of a multinational trial.
The Privacy Act 2020 and the Health Information Privacy Code 2020, supervised by the Privacy Commissioner.
Not with Capture. It hosts in the EU (Frankfurt) or the USA (N. Virginia). Check your institution's policy on offshore health data.
No. Support is by email, typically answered within 24 hours.
Yes. One study can hold sites in several countries with site-level access and by-site exports.
Yes. Capture suits Phase 1, 2 and 3.
Yes. The free sandbox has every feature, no credit card and no time limit.
Keep exploring
Clinical trial software Australia
The neighbouring regime.
Clinical trial software in Canada
Another non-EU country guide.
21 CFR Part 11 compliant EDC
US-style electronic records.
eConsent software
Signed, auditable consent.
Data ownership and portability
Keeping control of your data.
What is informed consent?
The basics.
EDC, ePRO and eConsent with an audit trail. Free sandbox, no credit card.