Guideline on the Regulation of Therapeutic Products - latest edition, November 2018
- Guideline on the Regulation of Therapeutic Products in New Zealand Part 11: Clinical trials – regulatory approval and good clinical practice requirement (pdf, 273 K - Medsafe.govt.nz)
HDEC Newsletter – Winter Edition 2018
This newsletter will give you an update on changes to HDECs standards and expectations, as well as pointing you in the direction of new guidance that has been created to help you through the application process.
Updated guidance on use of tissue – mandatory and optional procedures
We have recently updated the requirements for optional use of tissue and separate Participant Information Sheets and Consent Forms. If your study involves human tissue please review the new guidance to support your ethics application: Use of tissue and informed consent.
Template for participant information sheet and consent form update
The suggested text in the HDEC template participant information sheet for ‘commercially sponsored’ intervention studies has been updated.
Please view the Participant Information Sheet and Consent Form Template (Word, 112 KB) to ensure you are using the most up to date wording in your study documents.
Scope of review form – new version
Please view the new Scope of review form (Word, 222 KB). The form has been amended based on feedback and experience of the Secretariat.
HDEC website update
This update includes new user-focused guidance on how to check if your study requires HDEC review, submit an application for HDEC review, and details of the HDEC review and post-approval process.
New guides and templates have recently been added to the renamed Guides, templates and forms tab in the top bar menu.
Guides have also been added on answering the cultural questions in the application form, how to protect potentially vulnerable study participants, and how to submit an application for HDEC review of a tissue bank.
If you have any questions, feedback or suggestions, please contact the HDEC Secretariat:
How do I apply for HDEC review?
All applications to HDECs must be submitted through the Online Forms website. This site allows you to answer questions in the HDEC application form, upload documents, request electronic signatures from other parties involved in your research, and track the progress of your application. For more information, check the section HDEC review and approvals: