SOP for Clinical Trial Data Management and Integrity

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SOP for audit trail compliance NZ, SOP for electronic records NZ, SOP for data confidentiality NZ, SOP for trial subject protection data NZ, SOP for CAPA in data findings NZ, SOP for quality assurance data NZ”,
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Published on 21/12/2025

Clinical Trial Data Management and Integrity SOP

Department	Clinical Research
SOP No.	CS/NZ-DM/210/2025
Supersedes	N.A.
Page No.	1 of 26
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 standardized processes for managing and safeguarding clinical trial data in New Zealand. It ensures integrity, accuracy, and confidentiality of data in compliance with Medsafe, HDEC, and ICH GCP requirements.

Scope

This SOP applies to all sponsor-led and investigator-initiated trials in New Zealand. It covers Case Report Form (CRF) handling, data entry, query resolution, database validation, database lock, audit trails, and archiving. It applies to sponsors, investigators, CROs, data managers, and QA teams.

Responsibilities

Sponsor: Establishes data management plan, ensures secure EDC systems, and oversees CRO activities.
Principal Investigator (PI): Ensures accuracy of site-level data entry and resolution of queries.
Clinical Research Coordinator (CRC): Assists in timely data entry and source verification.
Data Manager: Oversees data validation, query generation, and database lock.
CRO: Provides data management services when delegated by sponsor.
Quality Assurance (QA): Audits data management processes and ensures CAPA implementation.

Accountability

The sponsor’s Head of Data Management is accountable for data management compliance. The PI is accountable for site-level data accuracy and completeness.

Procedure

1. Data Management Plan (DMP)

Prepare and approve a DMP covering CRF handling, query management, database validation, and archiving.
Maintain DMP in Trial Master File (TMF).

2. CRF Handling and Data Entry

Ensure CRFs are completed promptly and accurately.
Electronic CRFs (eCRFs) must be entered into EDC within 5 working days of subject visit.
Maintain CRF Completion Log (Annexure-1).

3. Query Management

Data managers issue queries for discrepancies.
Investigators resolve queries within 10 working days.
Maintain Query Resolution Log (Annexure-2).

4. Database Validation and Lock

Perform system validation checks prior to database lock.
Document lock approval in Database Lock Log (Annexure-3).

5. Data Privacy and Security

Ensure compliance with Privacy Act 2020.
De-identify subject data before analysis.
Maintain access control for EDC systems.

6. Archiving

Archive data management documentation in TMF and ISF for at least 10 years post-trial.
Ensure audit trails remain accessible for regulatory inspections.

Abbreviations

CRF: Case Report Form
eCRF: Electronic Case Report Form
PI: Principal Investigator
CRC: Clinical Research Coordinator
QA: Quality Assurance
CRO: Contract Research Organization
DMP: Data Management Plan
TMF: Trial Master File
ISF: Investigator Site File
CAPA: Corrective and Preventive Action
EDC: Electronic Data Capture
GCP: Good Clinical Practice
HDEC: Health and Disability Ethics Committees

Documents

CRF Completion Log (Annexure-1)
Query Resolution Log (Annexure-2)
Database Lock 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: CRF Completion Log

Date	Subject ID	Visit	Completed By	Checked By
10/08/2025	NZ-801	Visit 1	CRC: Anjali Rao	PI: Dr. Anita Patel

Annexure-2: Query Resolution Log

Date	Query ID	Query Description	Resolution	Resolved By
15/08/2025	QRY-2101	Missing AE date	Date corrected	Dr. Anita Patel

Annexure-3: Database Lock Log

Date	Database Name	Status	Approved By
25/08/2025	NZ-2025-DB	Locked	Head of Data Management

Revision History

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
28/08/2025	1.0	Initial SOP for clinical trial data management and integrity in New Zealand.	New SOP created for Medsafe, HDEC, Privacy Act 2020, and GCP compliance.	Head of Clinical Research

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