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Published on 21/12/2025

Informed Consent Process and Documentation SOP

Department	Clinical Research
SOP No.	CS/NZ-ICF/206/2025
Supersedes	N.A.
Page No.	1 of 24
Issue Date	28/08/2025
Effective Date	05/09/2025
Review Date	05/09/2027

Purpose

The purpose of this SOP is to establish standardized procedures for obtaining, documenting, and archiving informed consent in clinical trials in New Zealand. It ensures compliance with Medsafe, Health and Disability Ethics Committees (HDEC), and ICH GCP requirements to protect participants’ autonomy and rights.

Scope

This SOP applies to all clinical trials in New Zealand requiring informed consent from participants or legally acceptable representatives. It includes written, oral, and electronic consent (eConsent) processes, witness requirements, cultural considerations, and record retention.

Responsibilities

• Principal Investigator (PI): Ensures participants are adequately informed and that consent is obtained prior to trial participation.
• Clinical Research Coordinator (CRC): Assists in presenting trial information and documenting the consent process.
• Sponsor: Provides approved ICF templates, oversees training, and ensures updates are implemented across all sites.
• Regulatory Affairs (RA): Submits ICFs to HDEC for approval and ensures changes are tracked.
• CRO: Supports sponsor in site-level monitoring of the consent process.
• Quality Assurance (QA): Conducts audits of informed consent documentation and ensures compliance.

Accountability

The PI is accountable for ensuring that informed consent is properly obtained and documented at the site level. The sponsor is accountable for ensuring ICF compliance across all participating sites.

Procedure

1. Preparation of Consent Documents

1. Prepare ICF and Patient Information Sheet (PIS) in plain language, ensuring cultural appropriateness.
2. Submit documents to HDEC for review and approval.
3. Maintain version control in Consent Document Log (Annexure-1).

2. Consent Process

1. Present trial information in a private, distraction-free environment.
2. Allow sufficient time for participant questions and deliberation.
3. Involve whānau (family) if requested by participant.
4. Document subject understanding before signing.

3. Special Considerations

1. For illiterate subjects, obtain witnessed consent with thumb impression.
2. For vulnerable populations, ensure additional protections and witness involvement.
3. For eConsent, ensure system compliance with privacy and electronic signature regulations.

4. Documentation

1. Retain signed ICFs in ISF and provide a copy to the participant.
2. Log all consent events in Consent Documentation Log (Annexure-2).

5. Archiving

1. Maintain consent records for a minimum of 10 years after trial completion.
2. Ensure records are readily available for audits and inspections.

Abbreviations

• ICF: Informed Consent Form
• PIS: Patient Information Sheet
• PI: Principal Investigator
• CRC: Clinical Research Coordinator
• RA: Regulatory Affairs
• QA: Quality Assurance
• CRO: Contract Research Organization
• HDEC: Health and Disability Ethics Committees
• Medsafe: Medicines and Medical Devices Safety Authority
• ISF: Investigator Site File
• TMF: Trial Master File
• GCP: Good Clinical Practice

Documents

1. Consent Document Log (Annexure-1)
2. Consent Documentation Log (Annexure-2)
3. eConsent System Compliance Checklist (Annexure-3)

References

• HDEC — Health and Disability Ethics Committees
• Medsafe — Medicines and Medical Devices Safety Authority
• ICH E6(R2) Good Clinical Practice
• WHO Clinical Trial Standards

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: Consent Document Log

Date	Version	Prepared By	Status
01/08/2025	v1.0	RA Team	Approved

Annexure-2: Consent Documentation Log

Date	Subject ID	Consent Obtained By	Witness (if any)	Version
12/08/2025	NZ-501	Dr. Anita Patel	John Smith	v1.0

Annexure-3: eConsent System Compliance Checklist

Requirement	Compliant (Y/N)	Comments	Checked By
Electronic signature validation	Y	System verified	QA Team

Revision History

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
28/08/2025	1.0	Initial SOP for informed consent process and documentation in New Zealand trials.	New SOP created for Medsafe, HDEC, and GCP compliance.	Head of Clinical Research

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