Introducing the Clinical Trial Protocol Model (CTPM)
Clinical trial protocols are written for humans. They're dense PDFs full of inclusion criteria, visit schedules, assessment grids, and footnotes that reference other footnotes. Every component in a trial, source documents, EDC, CTMS, IRT, payments, needs information from that PDF, each built into a different format. The result: the protocol gets re-entered, by hand, into half a dozen systems before the first patient enrolls.
The Clinical Trial Protocol Model (CTPM) is our answer. It's a structured, digital protocol that captures all of the information once. From the CTPM, downstream deliverables are generated automatically.
What's in a CTPM
A CTPM is a typed schema, not a free-form document. It encodes the protocol's structure in fields that match how clinical operations actually work:
- Visit schedule with windows, dependencies, and conditional branches
- Assessment matrix mapping each procedure to the visits where it occurs
- Endpoint definitions with derivation rules and data sources
- Adverse event grading scales and reporting thresholds
Fields are CDISC-aligned where standards apply, with alignment expanding as the schema develops. The schema is versioned, so amendments produce a record of what changed rather than generating a new document from scratch.
The CTPM means that coordinators don’t have to continually rebuild their studies. The protocol is extracted once, and every downstream output is generated from it.
How it changes the workflow
When a coordinator uploads a protocol PDF, our extraction pipeline produces a draft CTPM in minutes. The coordinator reviews it, confirming visit windows, flagging ambiguous criteria, and signs off. From that point on, every downstream artifact is generated instantly.
Source documents
A protocol-aligned source document package generated directly from the CTPM, available as PDFs or within your existing templates. Version-locked to the CTPM revision, so when an amendment is uploaded, changes propagate automatically without rebuilding individual forms.
EDC builds
eCRF structures, visit schedules, and assessment configurations are generated from CTPM fields rather than manually built from a protocol read. When the CTPM updates, the build reflects the change without starting over.
CTMS dashboards
Visit calendars, milestone trackers, and recruitment funnels are populated from CTPM fields, refreshed when the CTPM updates. No more retyping protocol metadata into yet another dashboard.
The CTPM is live in our pilot deployments today. If you want to see it in action, get in touch, we'd love to walk through your protocols.