Patient Safety Narrative Writing for Trial Sponsors
Pubrica writes patient safety narratives for clinical trial sponsors and CROs. Our safety writers prepare narratives for deaths, serious adverse events and discontinuations to a single template, in one order and one tense, and reconcile each narrative against the safety database and the subject listings before delivery. This keeps a large narrative set consistent even when several writers contribute to it.
- One template across the set — same order, same tense, same level of detail, whether there are twelve narratives or four hundred
- Reconciled against the listings and the safety database, with a reconciliation log delivered alongside, because disagreement between narratives and tables is the most common finding
- The investigator’s causality assessment reported as theirs, not restated as the writer’s conclusion
- Priced per narrative, so that the estimate holds, because narrative count is where CSR budgets most often go wrong
- Written for the report they sit in, whether that is an ICH E3 clinical study report, a DSUR or a submission appendix
Death, SAE and discontinuation narrativesIncluded
One template across the whole setIncluded
Reconciliation against listingsIncluded
Safety database case processingYour PV function
Causality determinationThe investigator’s
Listings → drafted → reconciled → narrative set
- One template throughout
- Reconciled against listings
- Causality reported as the investigator’s
- Reconciliation log delivered
- Priced per narrative
Deliverables
Patient Safety Narrative Deliverables
Every narrative follows one template and one source of truth, and states only what the listings and the safety database contain.
Example from a narrative templateEvery narrative presents the same nine elements in the same sequence, so a reviewer reading the fortieth narrative can find the exposure dates immediately.
Example from a reconciliation logOnset date 14 March in the narrative, 14 April in the listing.Raised as a query, resolved at source as a transcription error in the listing, corrected in both documents and logged. Disagreement between narratives and tables is the most common CSR finding.
Example from a narrativeThe event was considered unrelated to study drug.The investigator assessed the event as unrelated to study drug; the sponsor considered it possibly related. Both positions are reported, because a disagreement that is not recorded can lead to questions in review.
Example from a scope definitionCSR narratives cross-reference the listings by number, whereas DSUR narratives stand alone because the reader has no listings. The same event is therefore presented differently in the two documents.
The samples shown are illustrative and anonymised. Hover over a sample to replay it.
Compliance and Standards
Patient Safety Narrative Guidelines and Quality Standards
Where your template or your safety function has a stated convention, that convention takes precedence. The standards below apply where no convention exists.
Clinical study report structure (with the 2012 Q&A (R1))
Where narratives sit in the report, what they must cover and how they are cross-referenced to the listings.
Clinical safety data management (definitions)
The definitions of serious, unexpected and suspected that the narratives have to apply consistently across the set.
Good Clinical Practice (E6(R3), not E6(R2))
The source-data expectations behind every date and dose in a narrative, and the audit trail behind any correction.
Quality management (cert. H3CR9TCU20251212INDQM10N)
How a large narrative set is drafted, reviewed, version-controlled and released as one deliverable.
Responsible Use of AI
Responsible Use of AI in Regulatory Writing
Regulatory reviewers trace each decision back to its evidence and to a responsible individual. For this reason, we treat source traceability as more important than drafting speed, and every statement in a regulatory document must be traceable to its source.
Why We Do Not Publish an AI Accuracy Figure
Accuracy figures for AI tools are usually reported by the companies that sell them.
Pubrica therefore does not quote a self-generated accuracy figure, because it would carry the same conflict of interest. Instead, we tell you which tool was used on your project, at which stage, and what a specialist changed afterwards.
Methodology
How We Write Your Patient Safety Narratives
Consistency across a narrative set depends on the process, so we settle the template and conventions before the first narrative is written rather than reconciling them after the last.
Template and scope agreed
We agree on your template or ours, fix the element order, confirm the narrative count by category (deaths, serious adverse events and discontinuations) and name the target document.
Drafting from source
A small team writes each narrative from the subject listings and the safety database, working to the agreed template.
Reconciliation
We check every narrative against the listings and the database, raise discrepancies as queries, resolve them at source and log each resolution.
Set-level review and delivery
We carry out a consistency review across the whole set, covering order, tense, terminology and cross-references, and deliver it with the reconciliation log.
Our Experts
Our Patient Safety Narrative Writing Team
A named team of regulatory specialists stays with your project from scoping to delivery. Your project coordinator introduces each team member by name before work begins.
Writes the document against the governing template and regulatory guidance, keeps every statement traceable to its source data, and maintains the version history and comment log through each review round.
Reviews the clinical and scientific content for accuracy and confirms that each conclusion is supported by the data. Each expert is matched to your therapeutic or device area.
Checks that statistical methods, tables and conclusions are consistent with the analysis plan, and reviews how the data are presented before the document reaches regulatory review.
Performs an independent check of the final document against source data, the template and the applicable regulatory checklist. Findings are logged and resolved before delivery.
Packages
Patient Safety Narrative Service Packages
Pricing depends on narrative complexity and the quality of the source material. A narrative built from a clean, complete listing costs considerably less than one assembled from scattered sources.
Narrative set
Sponsors and CROs needing a narrative set written or rewritten
Quoted per projectPer narrative · on complexity and source quality
Delivery By volume
- ✓Deaths, serious adverse events and discontinuations
- ✓One agreed template applied throughout
- ✓Reconciled against listings and the safety database
- ✓Reconciliation log delivered with the set
- ✓One review cycle across the set
Providing the counts by category at the quote stage allows us to give an accurate quote.
Deliverables Request a quoteRewrite of an existing set
For sets written by several writers, or returned with findings
Quoted per projectOn set size and the state of what exists
Delivery By scope
- ✓Existing narratives read for consistency and accuracy
- ✓Template imposed retrospectively across the set
- ✓Reconciliation against listings and database
- ✓Findings list where narratives and tables disagree
- ✓Rewritten set delivered with the log
A rewrite often costs less than expected. Most of the effort is in reading the existing set, and rewriting is quick once the template is fixed.
Deliverables Request a quoteNarrative count is the largest single source of estimate error in clinical study report work. Send us the counts of deaths, serious adverse events and discontinuations, and we will quote against those figures rather than an assumption.
FAQs
Patient Safety Narrative FAQs
If your question is not answered here, ask an expert — no quote is required.
Per narrative, on complexity and on how clean the source material is. A narrative built from a complete listing costs materially less than one assembled from several partial sources.
We quote against your counts by category rather than against an estimate, because narrative count is where clinical study report budgets most often go wrong.
At minimum, deaths, other serious adverse events and discontinuations due to an adverse event. ICH E3 sets that as the baseline and your protocol or safety plan may widen it.
Some sponsors also write narratives for adverse events of special interest or protocol-defined significant events. This scope decision is best settled at the quote stage.
The investigator. The narrative reports their assessment as theirs, and where the sponsor takes a different view, both positions are stated.
A narrative that presents the sponsor’s view as the only view misstates the record, and a disagreement left out of the narrative can become a question in review.
Yes. This is a common request, because sets written by several people over a long study are often inconsistent.
Most of the work is reading: establishing what the existing narratives say, where they disagree with the listings and what the template should be. Rewriting is quick once that is settled.
No. Case intake, coding and the safety database of record sit with your pharmacovigilance function or your provider. We write narratives from what that system holds.
This separation matters, because the narrative describes the recorded case, and a writer who also owned the record would be describing their own entry.
Related Services
Related Safety and Clinical Reporting Services
Narratives are one component of a larger safety and reporting package.
1CLINICAL STUDY REPORTINGoften commissioned together
Clinical study reportFull, abbreviated or synoptic, to ICH E3. Regulatory writingDSURs, RMPs and submission content.2SOURCE DATAthe source of narrative content
BiostatisticsListings, tables and figures from the locked dataset. Medical data collectionProtocol-driven collection and validation.3TRIAL DOCUMENTATIONdocumentation and disclosure
Clinical trial supportProtocol, SAP, ICF and registry records. Clinical evaluation reportFor devices, the evidence file.Request a Quote Based on Your Narrative Counts
Send us the number of deaths, serious adverse events and discontinuations, by category. Quoting against actual narrative counts keeps your clinical study report budget accurate.