Submission de-identification is the removal of patient IDs from documents bound for a regulator. It fits FDA 21 CFR Part 11 for electronic records. anonym.plus runs locally and keeps the study results and the product data intact.
When this applies
A submission packet holds case write-ups, listings, and tables that name subjects and investigators. Before you file, you clear those IDs only.
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.
PHI entity types detected
| Category | anonym.plus entity type | Example |
|---|---|---|
| Names | PERSON | subject R. Haddad → [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
- Fits FDA 21 CFR Part 11 electronic records for submissions.
- Keeps the study results and product data, which are not patient IDs.
- Offline work keeps the packet inside your sponsor team.
Anonymize submission documents offline — see plans & start free →
Limitations & cautions
Part 11 governs your validated record system, not the swap itself. The tool de-identifies a copy of a packet. 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 Part 11 compliant?
No. Part 11 covers 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 IDs, so they stay. Only subject and site IDs go.