Traceable research-site profile
Site Status
Combines readiness, experience, workload and risk indicators while preserving the source and date of every value.
Module purpose
Give sponsors and CROs a comparable evidence layer for discussion—not an opaque automated ranking.
Status
Public clinical and operational validation results and medical-device registration details have not been published. This module must not be treated as an approved medical device. Human approval remains mandatory for clinical, ethical and regulatory decisions.Public clinical and operational validation results and medical-device registration details have not been published. This module must not be treated as an approved medical device. Human approval remains mandatory for clinical, ethical and regulatory decisions.
Inputs
- Team and equipment profile
- Study and recruitment history
- Current workload and availability
- Documents and freshness status
How it works
- Checks completeness and provenance
- Separates measurement from estimation
- Maps site capability to study needs
- Shows gaps, risk and comparison rationale
Outputs
- Readiness profile
- Gap and risk map
- SITE-07 / SITE-12 comparison
- Evidence pack for expert selection
Human checkpoints
- Site attestation
- Freshness review
- Qualification by the authorised team
Automation boundaries
- Does not select a site autonomously
- Does not present forecasts as facts
- Does not expose sensitive operations data
Module video
Site Status: data for site assessment
The film explains the module with a synthetic example. It is not evidence of clinical effectiveness, validation, compliance or regulatory approval.
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