Self-testing studies, captured where they happen

Self-testing performance studies have a texture of their own: patients measure at home or at the bedside, devices and strips have serial numbers and lots, duplicate measurements must agree within protocol limits, and the comparison that matters is patient result versus professional result. This platform grew out of exactly such a study — a PT/INR self-monitoring trial at European sites — and it shows.

Capture that survives the ward

• Offline-capable iPad entry. Entries save automatically, queue through network drops, and sync when the connection returns. Nothing typed is lost.
• Touch-first forms. Large targets, section-by-section flow, and a signature pad sized for a real signature.
• Device traceability. Coagulometer serials and strip lots are picked from history, not retyped — a repeated SN is one tap, a wrong one is flagged.

Protocol rules, enforced at entry

Duplicate readings that differ beyond the protocol limit — ≥0.3 INR below the 2.0 threshold, ≥0.5 above it, in our PT/INR configuration — trigger an immediate, documented repeat-test prompt. Acceptance bands are scored as soon as the reference value arrives: ±0.4 absolute below 2.0 INR, ±20% to 4.5, ±25% to 6.0, ±30% beyond (ISO 17593 banding), with the verdict written back into the CRF. Adverse events go into log forms with no row limit; answering "withdrawn = yes" moves the subject to Withdrawn and locks the remaining forms automatically.

Patients kept on schedule — and their data minimized

Visit windows drive a daily e-mail digest to each site (overdue visits, unanswered queries, unsigned forms); the readiness score tells the sponsor exactly how close the study is to lock. Privacy is engineered for home-use populations: subjects exist only as pseudonymous codes, birth dates can be captured year-only, and every export of their data is logged with who took what, when. When the study locks, method-comparison statistics and CDISC exports are already waiting.