SOP for Clinical Trial Registration and Updates in ANZCTR

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Published on 23/12/2025

Clinical Trial Registration and Updates in ANZCTR SOP

Department	Clinical Research
SOP No.	CS/NZ-REG/205/2025
Supersedes	N.A.
Page No.	1 of 25
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 processes for clinical trial registration and updates in the Australia New Zealand Clinical Trials Registry (ANZCTR). This ensures transparency, ethical compliance, and alignment with Medsafe, HDEC, WHO, and International Committee of Medical Journal Editors (ICMJE) requirements for trial registration and result disclosure.

Scope

This SOP applies to all clinical trials conducted in New Zealand requiring ANZCTR registration. It covers initial registration, registry updates, posting of summary results, and management of registry-related communications. It applies to sponsors, investigators, CROs, regulatory affairs staff, and QA teams.

Responsibilities

Sponsor: Ensures timely registration of all trials in ANZCTR before first participant enrollment, maintains updates, and discloses results.
Principal Investigator (PI): Provides accurate trial data for registry submission and reviews registry entries for accuracy.
Regulatory Affairs (RA): Manages registry submissions, updates, and correspondence with ANZCTR.
CRO: Supports sponsor in registry management activities as per contractual agreement.
Quality Assurance (QA): Audits registry records for compliance with SOP and regulatory requirements.

Accountability

The sponsor’s Head of Regulatory Affairs is accountable for compliance with ANZCTR registration requirements. The PI is accountable for ensuring site-level accuracy of trial information submitted to the registry.

Procedure

1. Initial Registration

Register the trial in ANZCTR prior to enrollment of the first participant.
Include all required information: protocol title, objectives, eligibility criteria, intervention details, and outcome measures.
Retain a copy of the registry confirmation in the TMF and ISF.

2. Updates to Registry Records

Update registry records within 15 working days of protocol amendments.
Maintain Registry Update Log (Annexure-1).

3. Results Disclosure

Submit summary results to ANZCTR within 12 months of trial completion.
Ensure consistency with final study report and regulatory submissions.

4. Ethics and Regulatory Coordination

Provide registry details in HDEC submissions.
Ensure Medsafe acknowledges trial registration for regulatory acceptance.

5. Auditing and Archiving

QA team audits registry entries annually for accuracy.
Archive all registry-related documents for minimum of 10 years.

Abbreviations

ANZCTR: Australia New Zealand Clinical Trials Registry
HDEC: Health and Disability Ethics Committees
ICMJE: International Committee of Medical Journal Editors
PI: Principal Investigator
RA: Regulatory Affairs
QA: Quality Assurance
CRO: Contract Research Organization
TMF: Trial Master File
ISF: Investigator Site File

Documents

Registry Update Log (Annexure-1)
Registry Confirmation Record (Annexure-2)
Results Disclosure 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: Registry Update Log

Date	Protocol No.	Update	Submitted To	Status
10/08/2025	NZ-2025-04	Primary endpoint amended	ANZCTR	Approved

Annexure-2: Registry Confirmation Record

Registry ID	Protocol No.	Date Registered	Confirmation
ACTRN12625001001	NZ-2025-04	01/08/2025	Confirmed

Annexure-3: Results Disclosure Log

Date	Protocol No.	Results Posted	Status
20/08/2026	NZ-2025-04	Summary results disclosed	Completed

Revision History

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
28/08/2025	1.0	Initial SOP for clinical trial registration and updates in ANZCTR.	New SOP created for compliance with ANZCTR, Medsafe, HDEC, and ICMJE requirements.	Head of Clinical Research

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