RECORDREFERENCE OUTLINE

Serious Adverse Event Report Form

Trial SAE form separating the axes that get conflated: seriousness criteria and severity recorded in different places, investigator and sponsor causality both retained rather than one overwriting the other, expectedness judged against the reference safety version in force at onset, and a clock table that distinguishes the shorter fatal or life-threatening window. Maps to 21 CFR Part 312 and ICH E6(R3).

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
21 CFR Part 312ICH E6(R3)
DOCUMENT TYPE
Record
LAST UPDATED
August 2026
PURPOSE

Trial safety reporting is a relay with two clocks and three assessments, routinely confused with postmarketing case processing. Getting the relay wrong does not usually lose the event — it loses the deadline. The form keeps seriousness apart from severity and the investigator’s causality apart from the sponsor’s, because collapsing either pair is how a reportable event becomes an unreportable one on paper.

What's Inside

✓Event details with the site awareness date and the sponsor notification date recorded separately
✓Seriousness criteria selected explicitly, with severity recorded in a different field entirely
✓Investigator causality assessment, retained as given rather than overwritten during sponsor review
✓Sponsor causality assessment recorded alongside it, so a disagreement is visible rather than resolved silently
✓Expectedness judged against the reference safety document version in force at the time of onset
✓Clock table distinguishing the shorter fatal or life-threatening window from the standard one
✓Onward notification record covering investigators and the reviewing board, with the dates sent

How to Use It

1Record the site awareness date first, because every clock on this form runs from a date somebody must be able to evidence
2Keep seriousness and severity apart — a severe headache may be non-serious, and a mild event requiring hospitalisation is serious
3Record the sponsor assessment alongside the investigator’s, never replacing it; a single merged causality loses the disagreement that mattered
4Judge expectedness against the reference safety version in force when the event occurred, not against the current document
5Apply the shorter fatal or life-threatening clock separately; one uniform window is precisely how the short one is missed
6Record onward notification to investigators and the reviewing board with dates, because the relay is not finished at submission
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
1Event and Site Awareness
2Seriousness
3Causality — Both Assessments
4Expectedness
5Reporting Clock and Onward Notification
REGULATORY CONTEXT

21 CFR Part 312 sets the US investigational new drug safety reporting requirements, including the expedited reporting categories and the timeframes that attach to them, and ICH E6(R3) allocates the investigator and sponsor safety responsibilities either side of the relay. Neither makes the causality call, decides whether an event meets a seriousness criterion, or maintains your reference safety document. Those are investigator and sponsor determinations. The form structure, and the separation of the axes that get conflated, are SPEQ practitioner synthesis.

MAPPED STANDARDS
21 CFR Part 312ICH E6(R3)
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