Newborn Screening
Monitoring Platform
Tracking IEM & genetic disorders across 56 sites — from enrollment to confirmatory testing and follow-up.
56
Participating sites
24–72h
Sample collection window
10+
Modular forms
RBAC
Role-based access
System modules — data flow
Modular design from enrollment to outcome. All linked via unique Study ID.
A · Site registration
Hospital profile, ethics, equipment checklist, activation.
B · Newborn enrollment
Maternal history, demographics, study ID generation.
C · Informed consent
Version tracking, e-sign, witness, NGS separate consent.
D · Sample collection
DBS, barcode, quality, chain-of-custody, dispatch.
E · Lab screening
LC‑MS/MS, analyte panel, flagging, auto-alerts.
F · Confirmatory NGS
Targeted NGS, variant findings, ACMG, final diagnosis.
G · Follow-up & outcome
Referral, treatment, milestones, outcome status.
H · AE / deviation log
SAE, causality, CAPA, 24‑h reporting flag.
I · Monitoring / SDV
Visit log, query tracking, document review.
Role‑based access — 11 roles
| Role | Scope | Key permissions |
|---|---|---|
| Super Admin | Full system · 56 sites | User mgmt, audit log, dataset lock |
| Site PI | Own hospital | Approve entries, view site KPIs |
| Data Entry / Nurse | Own hospital, entry-only | Demographics, consent, sample |
| Lab Technician | Sample + results | LC‑MS/MS, flag abnormal |
| Genetics / NGS | Confirmatory testing | NGS results, variant upload |
| Follow‑up Physician | Assigned patients | Outcome, treatment, referral |
| Field Monitor | Assigned sites | SDV, monitoring logs, queries |
| Data Manager | Read‑only + export | Query resolution, dataset lock |
| Regulatory / Ethics | Read‑only | IRB, SAE, protocol deviations |
| Funding Agency | Aggregated dashboard | Progress KPIs, no PII |
Technical & compliance
- Data residency — India, DPDP Act 2023
- Encryption AES‑256 at rest · TLS 1.2+
- Offline‑capable with sync & conflict resolution
- Barcode/QR sample tracking, reduce errors
- Bilingual Hindi & English (consent, SMS)
- HL7/FHIR compatible schema (future)
Phased rollout
TAT dashboard · screen‑positive rate · rejection rate · loss‑to‑follow‑up