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GVP Module VIII - Post-Authorization Safety Studies (PASS) Audit Checklist

A comprehensive checklist for auditing the design, conduct, and reporting of post-authorization safety studies in compliance with GVP Module VIII requirements.

GVP Module VIII - Post-Authorization Safety Studies (PASS) Audit Checklist

by: audit-now
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About This Checklist

The GVP Module VIII Post-Authorization Safety Studies (PASS) Audit Checklist is an essential tool for evaluating the design, conduct, and reporting of post-authorization safety studies in the pharmaceutical industry. This comprehensive checklist assists auditors and pharmacovigilance professionals in assessing compliance with regulatory requirements and scientific standards for PASS. By systematically reviewing key elements of PASS processes, this checklist helps ensure the quality and integrity of safety data, supports regulatory compliance, and ultimately contributes to a better understanding of the safety profile of medicinal products in real-world settings.

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Industry

Healthcare

Standard

Pharmacovigilance Standards

Workspaces

Research Facilities
Pharmaceutical Offices
Research Facilities

Occupations

Pharmacovigilance Auditor
Epidemiologist
Clinical Research Associate
Medical Affairs Specialist
Regulatory Affairs Manager
1
Is the study compliant with GVP Module VIII guidelines?
2
What is the sample size of the study?
Min: 50
Target: 100
Max: 1000
3
What are the main objectives of the study?
4
What is the start date of the study?
5
What is the assessed risk level of the study?
6
How many adverse events have been reported during the study?
Min: 0
Target: 5
Max: 100
7
Have any risk mitigation measures been implemented?
8
What is the summary of the latest risk assessment?
9
What is the scheduled date for the next risk review?
10
Is there compliance with the established Risk Management Plan?
11
Is there a process in place to ensure data entry accuracy?
12
How many data queries have been raised during the study?
Min: 0
Target: 10
Max: 100
13
When was the last data verification conducted?
14
What are the comments on the current data management practices?
15
Is there compliance with audit trail requirements?
16
Has all relevant staff completed the required training for the study?
17
When was the last review of training materials conducted?
18
How many staff members are qualified to participate in the study?
Min: 0
Target: 8
Max: 50
19
What is the summary of the feedback received from training sessions?
20
Is there compliance with the training requirements set for the study?

FAQs

The primary focus is to assess the compliance and quality of post-authorization safety studies, including their design, conduct, and reporting, in accordance with GVP Module VIII requirements.

By ensuring rigorous PASS processes, the checklist helps generate reliable real-world safety data, contributing to a more comprehensive understanding of a product's safety profile post-authorization.

Audits should involve pharmacovigilance auditors, epidemiologists, clinical research professionals, medical affairs specialists, and regulatory affairs experts responsible for PASS activities.

The checklist covers areas such as study protocol development, ethical considerations, data collection methods, quality control processes, statistical analysis plans, and study reporting procedures.

PASS audits should be conducted at key milestones of individual studies, such as before study initiation, during data collection, and prior to final report submission, as well as periodically to assess overall PASS processes.

Benefits of GVP Module VIII - Post-Authorization Safety Studies (PASS) Audit Checklist

Ensures comprehensive evaluation of PASS design, conduct, and reporting

Facilitates compliance with GVP Module VIII requirements and other applicable regulations

Helps identify gaps in PASS processes and methodologies

Supports the generation of high-quality, reliable post-authorization safety data

Enhances the ability to make informed decisions about product safety in real-world use