PROTOCOLREFERENCE OUTLINE

Post-Authorisation Safety Study (PASS) Protocol

Protocol for a post-authorisation safety study, structured so the objective is specific enough that the design can be judged against it. Covers the safety question and what result would resolve it, design and population with justifications, an explicit test of whether the data source can observe the exposure and outcome, a pre-specified analysis plan, and dissemination including of an unfavourable result. Maps to EU GVP Module VIII.

What a template is not

A template is a document baseline to adapt inside your own quality system. SPEQ does not approve, validate, or take responsibility for what you issue from it, and using one is not evidence of compliance.

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REGULATIONS MAPPED
EU GVP Modules
DOCUMENT TYPE
Protocol
LAST UPDATED
August 2026
PURPOSE

A post-authorisation safety study is conducted after approval to identify, characterise or quantify a safety hazard, or to confirm the safety profile in use. The protocol succeeds or fails on one thing: whether the objective is specific enough that the design can be judged against it. Whether your data source can actually observe the exposure and the outcome is your determination, and no analysis rescues it later.

What's Inside

✓Study identification, obligation status and the public register entry that makes the protocol externally visible
✓The safety question stated with the finding that would resolve it and the finding that would not
✓Design, population, exposure, outcome and comparator, each carrying the justification for the choice made
✓A feasibility test of whether the data source can observe the exposure and the outcome at all
✓Pre-specified statistical analysis plan including sensitivity analyses and the handling of confounding
✓Safety reporting routes during conduct, so cases arising inside the study are not stranded there
✓Dissemination commitment covering an unfavourable result, with the timing fixed before any data are seen

How to Use It

1Write the finding that would close the safety concern and the finding that would not; an objective no result can conclude is the commonest defect.
2Establish that the data source records the exposure and the outcome before committing to it, and record what you checked.
3Justify the comparator explicitly; a comparator chosen for convenience decides the result more often than the analysis does.
4Specify the analysis before any data are seen — choices made afterwards leave the result uninterpretable, and the protocol history shows when they were made.
5Register the study before it starts and commit to publication including of an unfavourable result.
6Route amendments through the same approval path as the protocol; a silently amended objective is what makes a study unusable.
DOCUMENT CONTENTS

The full section structure of this template — every section and sub-section, so you can use it as a baseline for your own site document.

—Document Control
› Document Information› Approval Signatures› Revision History› Distribution List
1Study Identification
2The Safety Question
3Design and Population
4Data Source and Its Limitations
5Statistical Analysis Plan
6Safety Reporting, Conduct and Dissemination
REGULATORY CONTEXT

EU GVP Module VIII governs post-authorisation safety studies, setting the protocol content, entry in the public register, and the reporting obligations that attach to an imposed study. It does not decide whether your data source can answer your question, which comparator is defensible, or what result would resolve the concern — those judgements are the applicant’s and must be visible in the protocol rather than reconstructed afterwards. The design-critique framing here is SPEQ’s practitioner synthesis.

MAPPED STANDARDS
EU GVP Modules
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