# CSR Patient Narrative Drafting

> Patient narratives for deaths, serious adverse events and discontinuations, drafted to the ICH E3 clinical study report standard and page-cited to source.

Canonical page: https://medrecords.ai/solutions/csr-patient-narrative-drafting/

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[Home](https://medrecords.ai/) ›[Solutions](https://medrecords.ai/solutions/) ›CSR Patient Narratives
CSR PATIENT NARRATIVE DRAFTING

## 400 narratives, 1 house style, and a submission date.

CSR patient narrative services draft the individual narratives a clinical study report requires for deaths, serious adverse events and discontinuations. Each is built to the ICH E3 structure in your house style, page-cited to the source data, and delivered for your medical writer's review and sign-off.

[Test a file ](https://medrecords.ai/test-a-file/?src=csr-patient-narrative-drafting)
 [Book a demo](https://medrecords.ai/demo/)
Click any row → the source page it cites
Narrative draft · Case #IME-4812
 documented
Adams, Timothy
 · subject source data
342 pp / 2 packets received
 logged
11 duplicate pages removed
 free
p.140 — wrong patient
 quarantined
Pages 342
 Documents 27
 Cited 100%

### The reporting standard is published. So is the reviewer.

We do not build for a case type until we can name the standard that defines a correct output and the person who grades the file against it. In clinical study reporting, both are already published.

The standard and the referee
The rulebook
- ICH E3, which specifies the clinical study report structure and what a patient narrative must cover
- The sponsor's own narrative template and style conventions, which govern tense, terminology and level of detail
- The protocol's own definitions of adverse event, seriousness and discontinuation criteria
- MedDRA coding conventions, where preferred terms carry into the narrative

The referee
- The regulator's reviewer at submission, who reads narratives against the tabulated data
- The sponsor's medical writing and quality functions, which review and sign off every narrative
- The inspection, where narrative and source data are compared directly

Medical writer hours per narrative, multiplied across every event in the study

 Flat 10¢/page here, duplicates free
Narrative draft · Case #IME-4812
 cited 100%
Packet342 pp / 2 packets · 11 deduplicatedlogged
Event chronologyBuilt from the source datacited
Study drug exposureDose, dates and interruptionscited
Source discrepanciesListing and source disagreeflagged
Drafts delivered · cited 100% · no medical assessment authored
How it works

### 3 steps between the data and the report.

01

#### Send the source data and the template

Subject listings, source documents, the narrative template and your style conventions, in any format.

02

#### We return the drafts, page-cited

Each narrative in your template and house style, with the event chronology, exposure and outcome built from the source and cited to it, and discrepancies flagged.

03

#### Your medical writer reviews and signs off

The narrative is the sponsor's document. Medical assessment, causality language and sign-off stay with your medical writer and safety physician.

The boundary, in writing

### A drafted narrative, never a medical assessment.

We draft the narratives to your template from the source data and cite each statement to it. We do not assess causality, author a medical judgment, decide seriousness, or sign off a narrative. The narrative is the sponsor's document, reviewed and approved by the sponsor's medical writer and safety physician.

Where a subject listing and the source document disagree, the draft flags it rather than silently following one. A reviewer comparing narrative to source finds the discrepancy anyway, and a flag at draft stage is the cheapest place to resolve it.

Audit trail · Case #IME-4812
 exportable
08:12Packet received · 342 pp / 2 packetssystem
08:3111 pages deduplicatedsystem
08:44p.140 flagged — wrong patientsystem
08:54Narrative draft complete · drafts complete · sources cited · cited 100%system
09:20Narrative draft reviewed · citations verifiedreviewer
09:26Narrative draft exported · narratives signed off off-platformreviewer
Every access logged · file deleted 30 days after delivery
Why Medrecords AI

### The rules the platform never breaks.

EVERY LINE CITED
CASE #IME-4812 · ADAMS, T.342 pp
2/14 — ER visit, right knee
 p.4
4/18 — arthroscopic surgery
 p.61
p.140 — wrong patient
 quarantined
Medrecords AI
Read every page · cite every line

#### HIPAA, under a signed BAA

Every file is handled under our Business Associate Agreement, from the first byte.

#### Never trains a model

Your records are never used to train any AI model — ours or anyone else's.

#### Every line cited

If we can't cite it, we don't say it. Every sentence links to its source page.

#### Deleted after delivery

Files are deleted 30 days after delivery, with a full audit log of every access.

Powered by the platform

### 4 capabilities behind every narrative draft.

The narrative draft is 1 deliverable of the same platform that reads, sorts, and cites the whole record.

[

#### Medical Records OCR

Every source document read in full — subject listings, hospital records, laboratory reports, handwritten site notes — nothing skipped, nothing guessed.

IN ACTION · 342 pp / 2 packets → 27 documents, read in full
](https://medrecords.ai/product/ocr/)
 [

#### Medical Chronology

Each subject's course builds itself into a chronology, so exposure, event onset and outcome sit on one axis.

IN ACTION · first dose → event → outcome, 1 continuous timeline
](https://medrecords.ai/product/chronology/)
 [

#### Verifiable AI Citations

If we can't cite it, we don't say it. Every statement in the draft links to the source it was built from.

IN ACTION · every narrative → cited 100%
](https://medrecords.ai/product/citations/)
 [

#### Medical Summary Reports

The drafts format straight into the CSR — your template, your house style.

IN ACTION · narrative draft → writer-review ready
](https://medrecords.ai/product/summaries/)
FAQ

### CSR patient narratives, answered.

Your medical writer and safety physician. The narrative is the sponsor's document. We draft it to your template from the source data and cite every statement, so review is a check against the source rather than a rewrite.

No. Causality language reflects the safety physician's assessment and is theirs to author. The draft carries the documented facts — exposure, timing, course, outcome — each cited, and leaves the assessment where it belongs.

That's the main reason to do it this way. Consistency across a large narrative set is exactly what breaks when the work is split across writers under deadline, and it's what a reviewer notices first.

No. Medrecords AI does not retrieve records from providers or facilities. You bring the records you already have — review starts in minutes from upload. Retrieval vendors take days; you can keep yours and still cut the review to minutes.

### Send 1 file. We'll tell you what we can read.

No obligation. If the case type is buildable we'll scope it; if it isn't, we'll say so.

[Test a file ](https://medrecords.ai/test-a-file/?src=csr-patient-narrative-drafting)
 [Book a demo](https://medrecords.ai/demo/)
[See every case type we process →](https://medrecords.ai/solutions/case-types/)
