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SIH Buddyby Ganeev Singh
Dev
All problem statements
SIH26046Worth consideringacceptance 3/5

AIIA Clinical Trials Dashboard - a real-time, cloud-based, GCP-compliant Clinical Trial Management System (CTMS) for Ayurveda research, with CDISC/FHIR-interoperable data, role-based KPIs, and integrated ethics, regulatory (CTRI / NDCT Rules 2019) and pharmacovigilance tracking.

Ministry of Ayush · Space Technology · Software

The sponsor has removed the data barrier and told you exactly what to build and in what order, but this is enterprise regulatory software with almost no visible surface, so take the staging advice and make the adverse event reporting clock your demo rather than the portfolio view.

Data: Clinical-trial data is sensitive personal data, so development should use synthetic or de-identified datasets. Representative standards and public sources: Clinical Trials Registry – India public trial records (ctri.nic.in) and CDISC standards and controlled terminology covering CDASH, SDTM, ADaM and Define-XML (cdisc.org).

What it actually is

The All India Institute of Ayurveda runs a growing number of clinical trials and also coordinates national safety reporting for Ayurvedic medicines, but tracks all of it in spreadsheets. Nobody can see in one place which study is behind on recruitment, which ethics approval is expiring, or whether a serious side effect was reported to the regulator in time. The ask is a single monitoring system that covers the whole portfolio and the safety reporting together.

What to build

A trial management platform tracking each study across the lifecycle stages the statement names — protocol and ethics approval, CTRI registration, site activation, screening, enrolment against target, protocol deviations, data query status, milestones and close-out — surfaced as configurable KPIs with alerts for the specific triggers listed such as enrolment lag and overdue monitoring visits, plus an integrated pharmacovigilance module capturing adverse and serious adverse events, coding them to MedDRA and WHODrug and routing them against regulatory reporting clocks with aggregate signals to the safety monitoring board, all on CDISC-aligned data models with FHIR R4 interoperability, an immutable time-stamped audit trail, seven distinct role-based views and submission-ready SDTM and ADaM export.

Smallest thing that wins the room

Log a serious adverse event as a site coordinator and show the regulatory reporting clock start, the event auto-code to MedDRA, the safety board dashboard update, and the audit trail record who did what and when.

How crowded this one gets

A guess, projected from the 2025 statements — the last year where both the submission counts and the winners were published.

Moderate95–220 teams expectedroughly 1 in 80–186 wins it

Quieter than 67% of the 226 · #75 of 226 by expected field

A normal-sized field. Your idea has to be good, not miraculous.

Why: central ministry statements sat below the average.

This is a guess, not a fact

Nobody has published 2026’s numbers yet. This is an analysed estimate from last year’s pattern, so please do not take it as the truth — check the live counter on the SIH portal before you decide anything. The range covers the middle half of likely outcomes, so one statement in two lands outside it. Entry closes at 500 ideas per statement, so no range goes past that — a statement that reaches the cap fills and shuts rather than drawing an unlimited crowd. The model reads only three things a team can see before choosing — software or hardware, the theme, and what kind of body posted it — and those explain about a quarter of the variation in last year’s field sizes (R² 0.25 on held-out statements). Trust the band more than the number, and the ordering more than either. It cannot see how good your idea is, which is the part that actually decides it.

The scores

The number is the shorthand. The line under it is the reason.

What you will be writing

  • CDISC SDTM and ADaM data models with Define-XML export
  • HL7 FHIR R4 resources for ABDM interoperability
  • MedDRA and WHODrug coding integration
  • event-sourced immutable ALCOA+ audit trail
  • role-scoped dashboards with configurable KPI alerting
  • DPDP-aligned consent and encryption layer
  • Clinical research operations
  • Pharmacovigilance
  • Health data standards

Prior art to read before you start

clinical trial lifecycle and KPI monitoring · adverse event capture and regulatory timeline tracking · standards-conformant health data interoperability

Analysed by Claude Opus. Every score above is a judgment call with its reasoning attached — kindly cross-check this against the official statement on the SIH portal before your team commits to it.