Clinical suite domain map

Product verticals

The suite is organized around recognizable clinical product responsibilities. Each vertical page separates observed industry behaviour from the proposed TechSol domain decision.

Vertical	Owns	Review pack
Platform	identities, content versions, lifecycle enforcement, workflow, authority, audit, signatures and integration identity	Platform model
CTMS	Study/Country/Site operations, milestones, operational metrics, issues and monitoring	CTMS model
eTMF	expected records, classification, quality, completeness, timeliness and inspection availability	eTMF model
Study Startup	feasibility, selection, requirements, approvals, milestones, greenlight and activation readiness	Startup model
Payments	fee schedules, earned payable items, requests, adjustments and payment reconciliation	Payments model
Site Collaboration	sponsor/CRO-to-site document exchange, requests, reconciliation and distributions	Site Collaboration model
Study Training	curricula, training matrices, assignments, completion, qualification and evidence	Training model
Disclosures	registry obligations, registration/results versions, validation, approval and submission	Disclosures model
Site & Investigator Intelligence	curated investigator, institution, location and affiliation reference identity	Intelligence model
EDC	study collection design, Subjects, Casebooks, Events, Forms, Items, rules, queries, review, signatures and lock	EDC model
Clinical Data Quality	multisource ingestion, alignment, review, checks, reconciliation, provider queries and downstream packages	Data Quality model
RTSM	screening/randomization transaction, concealment, kit assignment, inventory, resupply and accountability	RTSM model
eCOA	instrument versions, schedules, administrations, responses, adherence and data changes	eCOA model

Suite flow

Platform identities and controls
│
├─ Site & Investigator Intelligence ──> CTMS / Startup master references
│                 ├─ Startup ──> site selected / greenlit / activated
│                 ├─ Payments <── visits, procedures and site fee events
│                 ├─ Site Collaboration <──> research site
│                 ├─ Study Training ──> qualification evidence ──> eTMF
│                 └─ Disclosures <── study/country milestones
│
├─ CTMS ── Study / Country / Site ──> EDC, RTSM, eCOA
│
├─ RTSM ── screening / randomization / kits ──> EDC, Clinical Data Quality
├─ EDC ── Subjects / Visits / Procedures / Deviations ──> CTMS, Data Quality, Payments
├─ eCOA ── assessment data / adherence ──> Clinical Data Quality
├─ Clinical Data Quality ── harmonized reviewed data packages ──> downstream analysis
└─ eTMF <── final evidence from operations, data, training, safety and closeout

Arrows carry named, versioned facts. They do not grant the receiving product authority to edit the publisher’s object.

What changed after product research

The model no longer presents EDC as generic forms and data points or eTMF as generic evidence.

• EDC now preserves the recognizable hierarchy of Study, Site, Subject, Casebook, Event Group, Event, Form, Item Group and Item, including rule-driven schedule changes, amendments, SDV/DMR, signature invalidation, freeze and lock.
• eTMF now maps EDL, EDL Item/Expected Document, matching, steady-state content, quality issues and TMF health into explicit expectation, fulfillment and assessment objects.
• CTMS distinguishes authoritative operations from integrated Subject/Visit projections and models Monitoring Event snapshots explicitly.
• Every vertical provides its source list and states where the TechSol model differs or still needs a product decision.

Verification status

EDC is the reference-depth candidate. The remaining verticals are evidence-backed v0.1 reconstructions: their boundaries and main objects are now recognizable, but their field-level contracts, full refusal catalogs and scenario suites still require product-manager review.

The evidence method states how product behaviour is promoted into the domain model and prevents vendor configuration from becoming architecture by accident.