Clinical study reports published under EMA Policy 0070 and Health Canada PRCI must have participants’ personal data anonymized. Re-Doc finds participant identifiers across narratives, listings and appendices and replaces them with consistent synthetic data, so the report stays readable for the researchers it is published for.
Illustrative example with invented data. Your anonymization rules (for example, relative days instead of dates) decide the exact transformations.
Clinical study reports are long, dense and full of participant details in places a simple search misses.
A single clinical study report can run to many hundreds of pages once patient narratives, listings and appendices are included. Every participant identifier, date and site detail has to be found and handled consistently across all of them.
Studies of published Policy 0070 reports found heavy redaction reduces what researchers can learn from them. Anonymization that replaces or generalises data keeps narratives and tables usable.
Subject IDs, initials, dates of birth, visit dates and site names appear in prose, tables and headers. If one form is missed, or replaced differently in two places, the report is either unsafe or confusing.
Sponsors filing in both the EU and Canada face EMA Policy 0070 and Health Canada PRCI. The two agencies have aligned their approach, but the documents still need careful, consistent handling for each release.
Re-Doc does the document-level work so your disclosure team can focus on decisions and review.
Your team defines what must be anonymized, what counts as CCI, and which method applies.
Participant identifiers across narratives, listings and appendices are replaced with consistent synthetic data, or redacted, in the original layout.
Your reviewers check the draft, adjust where needed, and handle CCI and edge cases.
Your team finalises the documents and the anonymization report for EMA or Health Canada.
The same pipeline covers publication packages and research data sharing.
Clinical overviews, summaries and study reports prepared for publication on the EMA clinical data site.
Clinical information prepared for public release through Health Canada’s clinical information portal.
Clinical documents shared with external researchers or data-sharing platforms, where readability matters as much as privacy.
Redaction removes information. Anonymization transforms it so the document keeps its value. Regulators prefer approaches that keep clinical reports useful.
Redaction blacks out or deletes text. It is simple, but heavily redacted narratives and tables tell researchers very little. It remains the right tool for commercially confidential information (CCI).
Anonymization transforms personal data, replacing identifiers with synthetic values, generalising dates to study days or years, grouping rare categories, so the risk of identifying a participant is low while the clinical story stays intact.
Re-Doc supports both: synthetic data replacement for participant data, and permanent redaction where your team marks CCI or other content to remove.
Replace participant identifiers in narratives (IDs, dates, ages, sites and other details) with consistent values, so each narrative still reads as a coherent case. EMA expects case narratives to be anonymised rather than fully redacted.
Re-Doc keeps one mapping across the report, so a participant has the same replacement ID in every narrative and table. Your disclosure team sets the rules, such as date offsetting or age banding, and reviews every change before the package goes out.
Health Canada's Public Release of Clinical Information (PRCI) asks sponsors to anonymize personal information in clinical documents before publication. Re-Doc does the document-level work: finding participant identifiers and replacing them consistently across the package.
Re-Doc does not compute the formal re-identification risk assessment or certify a submission. Your team, or a qualified expert, makes those decisions. Re-Doc removes the manual bottleneck of editing hundreds of pages.
Platforms such as Vivli and CSDR share clinical study documents with outside researchers, so participant identifiers must be removed first. Synthetic replacement keeps the documents readable for the researchers who request them.
The same pipeline handles CSRs, protocols and supporting documents. For documents that must stay inside your network, on-premise deployment is available on request.
Most anonymization is still done by specialist teams working page by page. Re-Doc gives them a consistent first draft.
| # | Typical tools in the market | Re-Doc | Status |
|---|---|---|---|
| 01 | Page-by-page manual review of every narrative and listing. | Identifiers found across the whole report in one pass, then reviewed. | ● Covered |
| 02 | Black boxes that make narratives hard to read. | Consistent synthetic data that keeps the clinical story readable. | ● Covered |
| 03 | Inconsistent handling when the same participant appears in many places. | The same participant gets the same synthetic identity throughout the report. | ● Covered |
| 04 | Separate tools for scanned pages and native files. | Native files and scanned pages handled by the same platform. | ● Covered |
Send us sample sections of a clinical study report. We run them through Re-Doc and share results your disclosure team can check before any wider use.
Related: document anonymization software · what de-identification means · about Re-Doc · PHI de-identification software · Document anonymization API
