TraceDraft · Clinical Study Report

ICH E3-aligned CSRs where the safety narrative appendix is generated in-line.

Compose Clinical Study Reports from your linked source data — AE listings, datasets, protocols — and generate the safety narrative appendix straight from the same source graph. One review workflow, one evidence pack, one traceable story from listing to submission.

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Traced to sourceEvery statement

Human reviewBefore anything is approved

In short

A Clinical Study Report presents the design, conduct, results and interpretation of a trial in the ICH E3 structure. TraceDraft drafts the sections that restate study data — disposition, demographics, exposure, efficacy and safety results — with each figure and statement linked to the dataset or table it came from, leaving interpretation to the medical writer.

The problem

Writer capacity is the ceiling, not data availability

By the time a CSR is due the data is locked and the tables, listings and figures exist. What delays the report is the number of qualified people available to turn them into prose, and that number does not flex with the number of studies.

The work splits unevenly. The discussion and conclusions need genuine clinical judgement. The disposition, demographics and exposure sections are a careful restatement of numbers that already exist in a table — exacting, slow, and not the best use of a senior writer's week.

So the critical path runs through people whose scarce judgement is being spent on transcription.

How TraceDraft handles it

Drafted where drafting is appropriate

The data-restatement sections are drafted from the tables, listings and figures directly, with each number traceable to its source table. Section structure follows ICH E3, so the output lands in the shape reviewers and regulators expect.

Interpretation is left alone. A benefit-risk discussion assembled by a model from the numbers around it is exactly the kind of content that should not be generated, and the drafting stops where judgement begins.

Draft safety narrative

Source data

1Adverse event listing · row 14
2Lab dataset · ALT value, day 15
3Protocol · section 7.2

Check the source, not the sentence

In a source-traceable clinical document, each statement links to the listing row, dataset value or protocol clause it came from, so a reviewer checks the source instead of trusting the sentence.

Numbers that match the tables

A figure in the narrative text that disagrees with the table it is supposed to summarise is one of the most common and most embarrassing CSR findings, and it usually arises from manual transcription during a late revision.

Values are carried from the source rather than retyped, and each one shows where it came from. When a table is reissued, the statements that depend on it are identifiable rather than needing a manual sweep of the document.

Built for the review that follows

A reviewer sees the draft alongside the table or listing each statement draws on. That is the design decision that determines whether drafting saves time overall, because generation speed is irrelevant if verification expands to absorb it.

Changes are tracked and attributable, a rejection needs a written reason, and the document can only be locked once every section is approved.

Deliverables

What you get

ICH E3 section structure, so output lands in the expected shape

Data-restatement sections drafted from the source tables, listings and figures

Every figure traceable to the table it came from, so narrative and tables cannot silently diverge

Interpretation and benefit-risk discussion left to the medical writer

Review with the source alongside the draft, and every approval recorded in the audit trail

Summary

What CSR Authoring delivers

CSR Authoring is part of the TraceDraft platform — an AI-native, source-traceable clinical documentation system built for regulated Life Sciences. See how it fits with CTD Clinical Summaries, Document Analysis, Safety Narratives.

CSR authoringClinical Study Report AIICH E3

ICH E3-aligned CSR delivery
Safety narrative appendix generated in-line
Section-level status and review
Export with the traceability pack attached

FAQ

Common questions

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Which parts of a CSR should AI draft?

The sections that restate study data — disposition, demographics, exposure, and the presentation of efficacy and safety results — where the work is careful transcription from tables that already exist. Interpretation, the benefit-risk discussion and the conclusions require clinical judgement and should be written by the medical writer.

How do you stop narrative text contradicting the tables?

By carrying values from the source rather than retyping them, and by keeping each statement linked to the table it came from. Transcription errors during late revisions are a common CSR finding; when a table is reissued, provenance makes the dependent statements identifiable rather than requiring a manual sweep.

Can an AI-assisted CSR be used in a regulatory submission?

Yes, where a qualified medical writer has reviewed and approved it and the usual record requirements are met. The AI is an authoring aid and accountability stays with the named author and approver. What a regulator cares about is that the content is accurate, traceable to source and approved under a compliant signature.

Related capabilities

All capabilities

CTD Clinical Summaries

Draft CTD Module 2.5 Clinical Overviews and Module 2.7 Clinical Summaries from your clinical study reports and integrated analyses. Each section carries the ICH M4E(R2) text it must satisfy, every sentence cites the study report passage or table behind it, and the benefit-risk conclusions stay with your writers.

Learn more about CTD Clinical Summaries Document Analysis

Upload an existing CSR, a vendor validation protocol, an SOP or a guideline and TraceDraft analyses it against the structure it should follow: a section-by-section summary, what each required section covers, what is missing, and where the text disagrees with itself. Every finding cites the uploaded document.

Learn more about Document Analysis Safety Narratives

A standard safety narrative template — Patient Identification, AE Description, Medical History, Study Drug, Clinical Course, Causality and Narrative Summary — with each section wired to the source types it needs. The final narrative slots directly into the CSR appendix.

Learn more about Safety Narratives Clinical Documentation

Project-scoped source management ingests the messy inputs — AE listings, datasets, protocols, PDFs — and turns them into the citable atoms behind every generated section. Writers see source coverage before they draft, so gaps are addressed early, not at QC.

Learn more about Clinical Documentation Human-in-the-Loop Reviews

A dedicated review queue routes generated sections to human reviewers with the source-link count in view — so reviewers validate AI output against the actual data behind it. The section status workflow keeps everyone honest about where a draft actually is.

Learn more about Human-in-the-Loop Reviews Clinical Automation

Generation, extraction and export run asynchronously so writers never wait for a spinner. Combined with the swappable AI provider, teams can automate draft production while keeping the human review gate exactly where it belongs.

Learn more about Clinical Automation