The NIS Handbook: Quality Oversight of Non-Interventional Studies (NIS)

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This handbook was developed for Quality Assurance (QA) professionals to support reviewing, advising and overseeing non-interventional studies (NIS) for medicinal products, but can be of use to anyone engaged in NIS for medicinal products.

The handbook offers practical considerations and insights to help the reader navigate existing guidance and apply a risk-proportionate approach to QA oversight of the design and conduct of NIS. The content draws on current industry standards, regulatory frameworks and the authors’ combined experience in this area. The regulations and guidance cited were accurate at the time of writing; readers should verify the latest requirements.

Robust QA oversight of NIS should be grounded on key concepts and principles, with careful attention to the complexity of relevant regulations. Given the diversity and nuances of different types of NIS, the degree of oversight should be tailored accordingly and remain proportionate to the associated risks.

The focus of this handbook is non-interventional studies of medicinal drug products (synonymous with drug product). Though some principles are the same, NIS related to medical devices are not discussed and are out of scope as the regulatory requirements differ significantly from medicinal drug products.

Contents

1. Background and Key Principles
2. Regulatory Framework
3. Types of Studies
4. Interface with Key PV Activities
5. Roles and Responsibilities and Common Operational Models
6. Quality Planning, Quality Governance and Controls
7. Risk-Based Audit Planning and Conduct for NIS
8. Appendix - Sample/examples of Risk Factors for Audit Risk Assessment and Audit Prioritisation in Non-Interventional Studies

Authors

Members of the Research Quality Association (RQA) Pharmacovigilance Committee, Japanese Society of Quality Assurance (JQSA) and the RQA Non-Interventional Study Special Interest Group

Published

2026