REPORTREFERENCE OUTLINE

Clinical Study Report

Study report following the expected structure, with an amendment table carrying the enrolment count at the time of each change, disposition that reconciles every participant enrolled, efficacy results labelled pre-specified or post-hoc, unfiltered safety, and a deviation section proportionate to the log it summarises. Maps to ICH E3.

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
ICH E3
DOCUMENT TYPE
Report
LAST UPDATED
August 2026
PURPOSE

The study report is the trial as it will be read, years after the people who ran it have moved on. Its integrity rests on describing what was actually done, including the parts that went wrong — reports are returned for omission far more often than for disappointing results. Which analyses were pre-specified and which were not is a fact about your statistical plan, not a presentation choice.

What's Inside

✓Identification and synopsis in the expected structure, so a reviewer finds each element where they look
✓Objectives and the design as conducted, which is not always the design as originally written
✓Amendment table carrying the enrolment count at the time of each change, not only its date
✓Disposition accounting for every participant enrolled, reconciled rather than summarised at a total
✓Efficacy results with each analysis labelled pre-specified or post-hoc, in the tables and the text
✓Safety presented unfiltered, including events the sponsor considers unrelated to the investigational product
✓Deviations, conclusions and the appendices that let an independent reader check the report

How to Use It

1Follow the expected structure rather than a house format; a rearranged report costs review time and invites questions about what moved
2Record enrolment at the time of each amendment, because describing amendments as the original design hides when the change was made
3Reconcile disposition until every enrolled participant is accounted for — unaccounted participants are among the commonest reasons reports are returned
4Label post-hoc analyses as post-hoc in the table and in the text, not only in a statistical appendix
5Present safety without filtering by the sponsor’s causality view; a reviewer expects to apply their own judgement
6Size the deviation section to the log it summarises, because a short section under a long log reads as selective
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
1Report Identification and Synopsis
2Objectives, Design and Amendments
› Design as conducted
3Disposition of Participants
4Efficacy Results
5Safety
6Deviations, Conclusions and Appendices
REGULATORY CONTEXT

ICH E3 defines the structure and content of a clinical study report — the synopsis, the design and its amendments, participant disposition, the efficacy and safety presentation, and the appendices that make the report checkable. It does not decide which analyses your statistical plan pre-specified, how you resolve a disposition discrepancy, or what your conclusions should say. Those belong to the sponsor and its statisticians. The practice guidance here is SPEQ practitioner synthesis about how reports fail review, not an extension of the guideline.

MAPPED STANDARDS
ICH E3
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