SOP for HDEC Ethics Submissions and Conditions of Approval

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Published on 21/12/2025

HDEC Ethics Submissions and Conditions of Approval SOP

Department	Clinical Research
SOP No.	CS/NZ-HDEC/200/2025
Supersedes	N.A.
Page No.	1 of 24
Issue Date	28/08/2025
Effective Date	05/09/2025
Review Date	05/09/2027

Table of Contents

Purpose

The purpose of this SOP is to define the process for preparing, submitting, and managing Health and Disability Ethics Committee (HDEC) submissions in New Zealand. It ensures compliance with New Zealand ethical standards, GCP requirements, and specific HDEC conditions of approval.

Scope

This SOP applies to all sponsor-led and investigator-initiated clinical trials requiring HDEC approval in New Zealand. It covers initial submissions, amendments, reporting obligations, and compliance with approval conditions. It is applicable to sponsors, investigators, CROs, regulatory affairs, and quality teams involved in New Zealand-based studies.

Responsibilities

Sponsor: Ensures completeness of submission packages, manages communications with HDEC, and complies with conditions of approval.
Principal Investigator (PI): Provides site-level documentation, ensures informed consent processes meet HDEC expectations, and maintains ISF accordingly.
Regulatory Affairs (RA): Submits initial and amended documents to HDEC via online systems, and ensures timely responses to queries.
CRO: Supports sponsor with preparation of submissions and communication with HDEC when delegated.
Quality Assurance (QA): Audits submissions and documentation for compliance and readiness for inspection.

Accountability

The sponsor’s Head of Regulatory Affairs is accountable for ensuring adherence to HDEC submission procedures. The PI is accountable for site-level compliance with conditions of approval.

Procedure

1. Initial Submission

Prepare documents: protocol, Investigator’s Brochure, ICF, PIS, CVs, and other required attachments.
Submit through the HDEC Online Submission System.
Record submission details in Submission Log (Annexure-1).

2. Review and Queries

Respond to HDEC queries within stipulated timelines.
Submit revised documents where requested.

3. Conditions of Approval

Review HDEC approval letter for specific conditions.
Ensure timely reporting of protocol deviations, amendments, and safety updates.
Maintain a Conditions of Approval Log (Annexure-2).

4. Amendments

Prepare amendment packages including updated protocols or consent forms.
Submit amendments via HDEC online system.

5. Reporting Obligations

Submit annual progress reports to HDEC.
Submit safety reports including SAEs and SUSARs as per HDEC guidelines.
Submit final report upon trial completion.

6. Archiving

Archive submission documents, communications, and approvals in TMF and ISF.
Maintain records for minimum 10 years after trial completion.

Abbreviations

HDEC: Health and Disability Ethics Committee
MFDS: Ministry of Food and Drug Safety
PIS: Patient Information Sheet
ISF: Investigator Site File
TMF: Trial Master File
RA: Regulatory Affairs
QA: Quality Assurance
PI: Principal Investigator
CRO: Contract Research Organization

Documents

Submission Log (Annexure-1)
Conditions of Approval Log (Annexure-2)
Amendment Log (Annexure-3)

References

Version: 1.0

Approval

Prepared By	Checked By	Approved By
Name: Rajesh Kumar Date: 20/08/2025 Signature: __________	Name: Sunita Reddy Date: 22/08/2025 Signature: __________	Name: Dr. Meera Iyer Date: 28/08/2025 Signature: __________

Annexures

Annexure-1: Submission Log

Date	Protocol No.	Documents Submitted	Status
10/08/2025	NZ-2025-01	Protocol, IB, ICF, PIS	Submitted

Annexure-2: Conditions of Approval Log

Date	Condition	Action Taken	Status
15/08/2025	Annual progress report required	Report prepared	Pending Submission

Annexure-3: Amendment Log

Date	Amendment	Submitted To	Status
20/08/2025	Protocol v2.0	HDEC	Approved

Revision History

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
28/08/2025	1.0	Initial SOP for HDEC ethics submissions and conditions of approval.	New SOP created for New Zealand compliance.	Head of Clinical Research

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