Trial Intelligence Brief Guide
The Trial Intelligence Brief is the first artifact PrismCDM produces from a protocol. It is also the most-read artifact across the platform. This guide explains what the Brief contains, who reads each section, and how the Brief fits into the operational workflow that follows.
What a Brief is.
A Trial Intelligence Brief is a structured, sourced, versioned document. It is the first product expression of the underlying Trial Intelligence engine. Every Brief is generated by the same engine that powers execution, evidence, and submission readiness, which means the conclusions in the Brief carry through into operational decisions without re-interpretation.
The Brief is not a deliverable. It is the first surface of an operating system that will keep producing intelligence for the entire life of the study.
What a Brief includes.
Every Brief carries the same canonical sections. Section order, identifiers, and structure are stable across protocols; the intelligence inside each section is specific to the protocol.
Structured summary of strategic posture. PTII™ composite plus the highest-impact findings and recommendations.
Composite index over five sub-indices: PCI / OBI / ESI / ARI / EVI. Each sub-index is explainable and individually traceable.
Structured observations with stable identifiers, severity, and source citations. Every finding can be referenced from operational decisions later.
Actionable next steps tied to findings. Recommendations carry into the execution workspace as discrete operational decisions.
Additional sections cover the protocol record, the corpus snapshot the Brief was generated against, integrity anchors, and the engine versioning stack. The full structure is documented in the methodology resource.
Who reads each section.
The Brief is the rare clinical document read by everyone on the study team. It is read differently at different altitudes.
Read the Executive Assessment, the PTII™ composite, and the top recommendations. Five minutes is enough to make a strategic decision.
CDM Lead, Medical Monitor, Data Manager, CRA, Regulatory Lead, Statistician. Read findings and recommendations in their domain and act on them through the execution workspace.
How the Brief fits into the operational workflow.
The Brief is not a deliverable that gets read once and filed. It is the entry point to an operational substrate that keeps producing intelligence for the life of the study. Every finding carries a stable identifier. Every recommendation can be accepted, deferred, or declined with the rationale captured. The execution workspace consumes those decisions directly.
When the protocol is amended, the engine re-runs and the Brief re-emits. The integrity anchors make the comparison auditable. Findings that changed are flagged; findings that survived carry their identifiers forward.
Every conclusion in every Brief is sourced. Every Brief is versioned against the engine, the assessment framework, the corpus snapshot, and the build that produced it. Inspections can trace any line from the Brief back to the source it came from.