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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

Pharmaceuticals

Standard

Good Pharmacovigilance Practices (GVP) Module VIII

Workspaces

Pharmaceutical company offices
Clinical research organizations
Academic research institutions

Occupations

Pharmacovigilance Auditor
Epidemiologist
Clinical Research Associate
Medical Affairs Specialist
Regulatory Affairs Manager

Post-Authorization Safety Studies Audit

(0 / 5)

1
What is the assessed risk level of the study?

Select the risk level based on the study design.

To evaluate the potential risks associated with the study.
2
What is the start date of the study?

Select the date when the study commenced.

To track the timeline of the study for compliance.
3
What are the main objectives of the study?

Provide a detailed description of the study objectives.

To review the clarity and relevance of study objectives.
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4
What is the sample size of the study?

Enter the total number of participants.

To assess if the sample size meets the regulatory requirements.
Min: 50
Target: 100
Max: 1000
5
Is the study compliant with GVP Module VIII guidelines?

Select compliance status.

To ensure adherence to established safety study protocols.
6
Is there compliance with the established Risk Management Plan?

Select the compliance status regarding the Risk Management Plan.

To verify adherence to the risk management framework as per GVP standards.
7
What is the scheduled date for the next risk review?

Select the date for the next risk review.

To ensure timely evaluations of ongoing risks throughout the study.
8
What is the summary of the latest risk assessment?

Provide a detailed summary of the latest risk assessment findings.

To ensure that risk assessments are documented and reviewed regularly.
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9
Have any risk mitigation measures been implemented?

Select whether risk mitigation measures have been implemented.

To verify if appropriate actions have been taken to address identified risks.
10
How many adverse events have been reported during the study?

Enter the total number of adverse events reported.

To assess the safety profile and identify trends in adverse events.
Min: 0
Target: 5
Max: 100
11
Is there compliance with audit trail requirements?

Select the compliance status for audit trail requirements.

To ensure that all data changes are logged and traceable for accountability.
12
What are the comments on the current data management practices?

Provide comments regarding the data management practices.

To gather qualitative feedback on data handling processes and identify areas for improvement.
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13
When was the last data verification conducted?

Select the date of the last data verification.

To ensure that data verification activities are performed regularly.
14
How many data queries have been raised during the study?

Enter the total number of data queries raised.

To assess the frequency of data discrepancies and the effectiveness of data management.
Min: 0
Target: 10
Max: 100
15
Is there a process in place to ensure data entry accuracy?

Indicate whether a data entry accuracy process exists.

To confirm that data input methods minimize errors and maintain data integrity.
16
Is there compliance with the training requirements set for the study?

Select the compliance status regarding training requirements.

To confirm adherence to the training protocols defined for study personnel.
17
What is the summary of the feedback received from training sessions?

Provide a summary of the feedback received from training.

To gather insights on the effectiveness of the training provided.
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18
How many staff members are qualified to participate in the study?

Enter the total number of qualified staff members.

To ensure that there are enough qualified personnel for study execution.
Min: 0
Target: 8
Max: 50
19
When was the last review of training materials conducted?

Select the date of the last training review.

To verify that training materials are current and relevant.
20
Has all relevant staff completed the required training for the study?

Indicate whether all staff training has been completed.

To ensure that all personnel are adequately trained for their roles in 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

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