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Published on 26/12/2025

Clinical Trial Monitoring and Oversight SOP

Department	Clinical Research
SOP No.	CS/NZ-MON/207/2025
Supersedes	N.A.
Page No.	1 of 27
Issue Date	28/08/2025
Effective Date	05/09/2025
Review Date	05/09/2027

Purpose

This SOP defines standardized processes for clinical trial monitoring and oversight in New Zealand. It ensures compliance with Medsafe, HDEC, and ICH GCP requirements to safeguard participant rights, ensure data integrity, and verify protocol adherence.

Scope

This SOP applies to all sponsor-led and investigator-initiated trials requiring monitoring in New Zealand. It covers planning, conducting, documenting, and archiving monitoring activities. It applies to sponsors, Clinical Research Associates (CRAs), investigators, CROs, and QA teams.

Responsibilities

• Sponsor: Develops monitoring plan, ensures monitors are trained, and oversees CRO activities.
• Principal Investigator (PI): Ensures site readiness, provides access to source data, and implements corrective actions.
• CRA/Monitor: Conducts monitoring visits, verifies source data, and prepares monitoring reports.
• Regulatory Affairs (RA): Provides oversight of monitoring compliance with Medsafe and HDEC expectations.
• QA: Audits monitoring records and verifies implementation of CAPA.
• CRO: Performs monitoring activities on behalf of sponsor if delegated.

Accountability

The sponsor’s Head of Clinical Operations is accountable for trial monitoring compliance. The PI is accountable for ensuring timely resolution of monitoring findings at site level.

Procedure

1. Monitoring Plan Development

1. Sponsor or CRO develops a risk-based monitoring plan.
2. Include monitoring frequency, visit types (remote/on-site), and SDV requirements.
3. File approved monitoring plan in TMF (Annexure-1).

2. Pre-Study Visit (PSV)

1. Evaluate site facilities, staff, and regulatory compliance readiness.
2. Document findings in PSV Report (Annexure-2).

3. Initiation Visit (SIV)

1. Train site staff on protocol, GCP, and reporting requirements.
2. Ensure essential documents are present in ISF.

4. Routine Monitoring Visits

1. Verify informed consent documentation.
2. Review source data for accuracy against CRFs/EDC entries.
3. Check investigational product accountability.
4. Document visit findings in Monitoring Visit Report (Annexure-3).

5. Close-Out Visit

1. Verify data completeness, archiving, and ISF reconciliation.
2. Ensure pending queries and CAPAs are resolved.

6. Documentation and Archiving

1. Maintain monitoring logs and reports in TMF and ISF.
2. Archive monitoring documentation for at least 10 years post-trial.

Abbreviations

• CRA: Clinical Research Associate
• PI: Principal Investigator
• RA: Regulatory Affairs
• QA: Quality Assurance
• CRO: Contract Research Organization
• TMF: Trial Master File
• ISF: Investigator Site File
• SDV: Source Data Verification
• CAPA: Corrective and Preventive Action
• HDEC: Health and Disability Ethics Committees
• Medsafe: Medicines and Medical Devices Safety Authority

Documents

1. Monitoring Plan (Annexure-1)
2. Pre-Study Visit Report (Annexure-2)
3. Monitoring Visit Report (Annexure-3)

References

• Medsafe — Medicines and Medical Devices Safety Authority
• HDEC — Health and Disability Ethics Committees
• 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: Monitoring Plan

Date	Protocol No.	Prepared By	Status
01/08/2025	NZ-2025-07	RA Team	Approved

Annexure-2: Pre-Study Visit Report

Date	Site	Findings	Assessed By
05/08/2025	Auckland Hospital	Site facilities adequate	CRA: Neha Sharma

Annexure-3: Monitoring Visit Report

Date	Site	Key Findings	Monitor
20/08/2025	Christchurch Clinical Centre	2 ICF corrections, resolved	CRA: Rahul Menon

Revision History

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

For more SOPs visit: Pharma SOP.