SDTM Dataset De-Identification with anonym.plus

Mask USUBJID and free-text comments without uploading the submission file.

SDTM de-identification is the removal of subject keys and stray text identifiers from the file. It supports CDISC SDTM submission structure. anonym.plus works offline and leaves the domain variables in place.

When this applies

An analyst shares a domain export with a partner who has no right to see who the subjects are. The USUBJID and comment fields must be masked.

How anonym.plus handles it

  1. Open the export (XPT, CSV, or XLSX) in anonym.plus on your machine.
  2. The tool reads each domain and flags subject keys and comments.
  3. Local OCR handles any scanned annotation page you add.
  4. Check the flagged USUBJID values and free-text notes.
  5. Mask the key, or swap it for a stable pseudonym across domains.
  6. Save the result locally. The source export never leaves your device.

What you need to provide

PHI entity types detected

Categoryanonym.plus entity typeExample
Subject keyIDUSUBJID 01-701-1015 → [PSEUDO_1]
Names in commentsPERSON"called daughter Mei" → [PERSON]
DatesDATE_TIMERFSTDTC 2026-01-09 → [DATE]
SiteLOCATIONSite 701, Boston → [SITE]
ContactPHONE_NUMBER617-555-0188 → [PHONE]
InvestigatorPERSONDr. Patel → [INVESTIGATOR]

Compliance achieved

Anonymize SDTM datasets offline — see plans & start free →

Limitations & cautions

Masking USUBJID can break a join if you need to merge domains later. Keep a separate key map for that, held apart from the shared copy. Free-text comment variables are the main place stray names hide; review those closely.

Frequently asked questions

What is USUBJID in CDISC SDTM?

It is the unique subject identifier that links a person across every domain. On its own it is an indirect identifier. Masking or pseudonymising it stops a partner from tracing a single subject across the export.

Where do stray names usually appear?

In free-text comment variables and supplemental domains. People type a relative's name or a town. The tool scans these fields and flags such text.

Can I keep the domains joinable?

Yes, if you apply one stable pseudonym per subject. Keep the original key map in a separate, protected place so only you can re-link.