Submission de-identification is the removal of patient IDs from documents bound for a regulator. Marketing authorisations are granted under Part 5 of the Human Medicines Regulations 2012, within the framework updated by the Medicines and Medical Devices Act 2021. anonym.plus runs locally and keeps the study results and product data intact.
When this applies
A submission packet holds case write-ups, listings, and tables that name trial participants and investigators. Module 5 of the dossier is where the clinical listings sit — and where personal identifiers pile up.
How anonym.plus handles it
- Point anonym.plus at the packet on your device.
- It scans listings and free-text write-ups for names.
- Subject IDs, dates, and sites get flagged across files.
- Confirm the flags; the study and product data stay.
- Swap IDs with a steady map to keep subject links.
- Save the clean packet; the source stays on your machine.
What you need to provide
- The packet (PDF, DOCX, CSV, or a bundle).
- A column map for subject and site ID fields.
- Replace with a steady map to keep subject joins.
Patient data entity types detected
| Category | anonym.plus entity type | Example |
|---|---|---|
| Names | PERSON | subject R. Hassan → [SUBJECT] |
| Names | PERSON | investigator → [INVESTIGATOR] |
| Record IDs | ID | subject no. 4471 → [SUBJECT_ID] |
| Dates | DATE_TIME | visit 09 Feb → shifted [DATE] |
| Location | LOCATION | trial site 3 → [SITE] |
| Identifiers | EMAIL_ADDRESS | site@example.com → [EMAIL] |
Compliance achieved
- Marketing authorisation dossiers are filed under Part 5 of the Human Medicines Regulations 2012, within the framework updated by the Medicines and Medical Devices Act 2021.
- Dossier structure follows ICH M4, the Common Technical Document, whose Module 5 carries the clinical study reports and their patient listings.
- Trial data taken into a submission stays governed by the Medicines for Human Use (Clinical Trials) Regulations 2004 (SI 2004/1031).
- The source system is still governed by the MHRA ‘GXP’ Data Integrity Guidance and EU GMP Annex 11; the tool de-identifies an export.
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Limitations & cautions
MHRA GxP expectations and Annex 11 govern your validated record system, not the swap itself. The tool de-identifies a copy of the packet, never the source records you must be able to reconstruct on inspection. Listings mix tidy columns with free-text write-ups, so review the free text as you would any narrative.
Frequently asked questions
Does this make my packet GxP compliant?
No. The MHRA data integrity guidance and Annex 11 cover your validated record and signature system. The tool only de-identifies a copy of the documents for safe handling.
Can subjects stay linkable across files?
Yes. A steady label map swaps each subject the same way, so listings still join while no real identity is left.
Are the study results kept?
Yes. Results and product data are not patient identifiers, so they stay. Only the participant and site identifiers go.