Sign in once — ProCTTH detects your role and unlocks exactly the right screens, permissions and mascot buddy.
Site staff can complete forms in basements, clinics and home visits. Everything syncs the moment you're online.
Compliant e-signatures with biometric confirmation, tied to a fully immutable audit trail.
AE/SAE alerts, protocol deviations and query pings route to the right role instantly — no email lag.
| Capability | Investigator | Coordinator | CRA |
|---|---|---|---|
| View subject identity (PII) | Yes | Yes | Blinded |
| Capture / edit eSource forms | Edit | Create & edit | Read only |
| Part-11 e-signature | Yes | Co-sign | No |
| Raise & resolve queries | Resolve | Resolve | Raise |
| Visit calendar management | View | Full control | View |
| Telemedicine with subjects | Yes | Yes | No |
| Audit trail & KRI dashboards | Site level | Site level | All sites |
The coordinator opens the day view, sees every scheduled subject with their visit window, required procedures and outstanding items, and works straight down the list. Forms open pre-populated with wearable vitals and prior-visit values, and each completed procedure ticks off the protocol checklist in real time.
Why it matters · Visit documentation is finished before the subject leaves the clinic, instead of being reconstructed from notes days later.
Dr. Hoot’s queue surfaces exactly what needs medical judgement: eligibility decisions, abnormal lab flags, AE causality assessments and forms awaiting Part-11 signature. Each item opens with the full clinical context — trend charts, prior visits and source attachments — on one screen.
Why it matters · PIs stop chasing paper and the site’s oversight obligation is evidenced by a timestamped, immutable trail.
Sleuth works entirely on coded records. Risk-based monitoring surfaces the subjects and fields most likely to carry error, so the CRA reviews what matters rather than 100% of everything, and raises queries against the exact field with a full change history beside it.
Why it matters · Monitoring visits shorten, query cycles close faster, and the site never has to prepare a separate binder for the CRA.
When a subject reports an event, the app routes it by severity: coordinators get the intake, the investigator gets the assessment task, and SAEs trigger the reporting clock with countdown timers against regulatory deadlines.
Why it matters · Nothing sits in an inbox — every safety item has an owner, a deadline and an escalation path.
Forms, signatures and attachments are queued in an encrypted local store and reconciled field-by-field on reconnect, so two staff members working the same visit never overwrite each other.
The app is the same data layer as the ProCTTH web workspace. Start a form on a tablet at the bedside, finish it on desktop — it is one source record, not a copy.
Redaction happens before data leaves the site tenant. A CRA device never receives identifiers, so a lost phone cannot expose PII.
Biometric unlock, configurable session timeouts, remote wipe of the local queue, jailbreak/root detection and certificate pinning.
We create your tenant and load the protocol, visit schedule and form library.
Delegation log drives access — each user gets only the screens their role permits.
In-app guided tours plus a 45-minute live session per role, with completion records.
First-visit support from a ProCTTH specialist shadowing your coordinator.
