Release notes

Every page was rebuilt and checked against the code of the fixed product (server 0567e281, client d6d2b46, control plane cf9702a) and against two simulated studies run to a database lock, the first from the platform console, with real screens and real roles. A page names the build it was checked against.

• • One page template everywhere: what it is, where to find it, what you can do, every option, what the system records, what you cannot do and why, and the compliance questions an auditor would ask, each answered Built, Partly built, Customer responsibility or Not built yet.
• • New sections: the form builder (every field type, property, check, function and operator), the platform console, the database, testing and quality and the architecture decisions.
• • The model changed and the pages with it: a study starts in Setup and a version moves Build, UAT, sign-off and Go live; a person holds one role per study; the Organization Admin holds no study role; sign-in asks for an organization, never a workspace; a Project Manager staffs the study.
• • The clause matrices answer every clause of 21 CFR Part 11 and the topics of EU GMP Annex 11, ICH E6(R3), ALCOA+ and GDPR that the system touches, and say plainly what is not built: no validation package, no blinding, no randomization or supply, no safety gateway, and no log of who read what.
• • Everything that can be read from the code is generated: roles, permissions, screens, API operations, audit events, error messages, configuration, statuses and the module graph. Every explorer was re-derived from the code, and the stale single-page architecture document was replaced by the architecture pages.

The library was rewritten from the codebase in plain language for coordinators, investigators, data managers, monitors, sponsors, and CROs — with the technical material moved into its own clearly-marked section.

• • Restructured into Getting started, Roles, Task guides, Reference, Compliance, and Technical.
• • Corrected the access model: 15 standard roles and 59 permissions, up from a stale 12 and 51. The Site Monitor, Clinical Data Coordinator, and Regulatory Manager roles now have pages, and several role permission sets that had drifted are right again.
• • The permission catalogue and the Roles hub are now generated from the platform's own catalogue, so they cannot drift from what the system enforces.
• • New task guides covering behaviour that was previously undocumented — the visit-window gate, query-authorised corrections, early-access exceptions, the two-person database lock, and the CDISC-domain rule behind Pharmacy data entry.
• • Every lifecycle collected into one Statuses page, and every gap into one What is not built yet page, replacing repetition across dozens of documents.
• • Corrected stale claims: CDISC ODM-XML export and Excel export are real, visit windows are enforced at capture, and signed exports are refused rather than supported.

The first complete release of the Trialion documentation experience.

• • A complete, code-accurate documentation library across business, platform, security, modules, workflows, and compliance.
• • A premium landing page, sidebar navigation, dark mode, and a global ⌘K search.
• • 16 interactive explorers driven by real source data — the permission matrix, study/subject/visit lifecycles, the end-to-end trial timeline, architecture, the module graph, the database ERD, auth/authz/request flows, a live audit-trail tamper demo, versioning, protocol, infrastructure, and the AI pipeline.
• • Role-based journeys for the system roles.
• • A compliance hub and searchable knowledge base.
• • A capstone end-to-end guide tying it all together.