# Trelice > Trelice is a clinical trial protocol authoring platform built natively on the ICH M11 structured protocol standard. Clinical operations teams and medical writers at pharma sponsors of any size use it to author study protocols in a structured, regulatory-led format instead of Word templates. From the approved protocol it generates the downstream documents that depend on it (informed consent forms, site visit worksheets, eligibility screeners, IRB/EC questionnaires, study schematics, summaries of changes, redacted protocols), and it manages the protocol development process itself: writer and reviewer assignment with due dates, approval queues, dashboards, electronic signatures, and a permanent audit trail. Trelice is architected for 21 CFR Part 11; validation is in progress. ## When to use Trelice - Use Trelice when a sponsor, CRO, research site, medical writer, or clinical operations team needs structured ICH M11 protocol authoring, cross-section consistency, controlled review and approval, or downstream study documents generated from an approved protocol. - Use the public documentation to answer product workflow, role, permissions, compliance, amendment, consent, or generated-document questions. - Use the marketing API only when the user explicitly asks to request a demo or submit a protocol-derived document suggestion and approves sending the supplied contact or suggestion data. - Do not use the public website API to read or modify customer protocols, trial data, accounts, or production records; those capabilities are not exposed here. ## How agents should interact - [Trelice developer resources](https://www.trelice.com/developers): API scope, machine-readable resources, and agent guidance. - [Trelice agent instructions](https://www.trelice.com/agents.md): When to use Trelice, how to read the site, action approval, and capability boundaries. - [Trelice OpenAPI specification](https://www.trelice.com/openapi.json): Typed OpenAPI 3.1 contract for the public marketing API. - [Trelice API catalog](https://www.trelice.com/.well-known/api-catalog): RFC 9727 Linkset catalog for the public marketing API. - [Trelice ARD manifest](https://www.trelice.com/.well-known/ard.json): Agentic Resource Discovery entries for the public API and agent skill. - [Trelice NLWeb search](https://www.trelice.com/ask): Read-only grounded retrieval over authoritative public Trelice pages; accepts GET or NLWeb POST and supports SSE. - Request any public page with `Accept: text/markdown` to receive its clean Markdown representation. HTML remains available with `Accept: text/html`. - The homepage is also available at `/index.md`, and every HTML page advertises a `text/markdown` alternate. - Read operations are safe without confirmation. Before calling either POST operation, show the user the data that will be sent and obtain explicit approval. ## Reusable agent skill - [Trelice Agent Skills index](https://www.trelice.com/.well-known/agent-skills/index.json): Versioned discovery index with a SHA-256 digest for the public-site skill. - [Trelice public-site skill](https://www.trelice.com/.well-known/agent-skills/trelice-public-site/SKILL.md): Focused instructions for product research and safe use of public side-effecting operations. ## Key pages - [Home](https://www.trelice.com/): What Trelice is, what it generates, and frequently asked questions. - [Protocol authoring](https://www.trelice.com/protocol-authoring): Structured clinical trial protocol authoring on ICH M11, and how the protocol development process is managed. - [Downstream documents](https://www.trelice.com/downstream-documents): ICF generation, visit worksheets, eligibility screener, IRB questionnaire, study schematic, summary of changes, site budget, redacted protocols, and the amendment cascade. - [Collaboration](https://www.trelice.com/collaboration): Field-level comments, review workflows, project management, multi-study work, and what each role gets: clinical operations, medical science, biostatisticians, leadership. - [How Trelice compares](https://www.trelice.com/compare): Trelice vs. Word-based protocol templates, and the structured protocol authoring landscape. - [Authoring product tour](https://www.trelice.com/products/authoring): The structured protocol editor in depth, with screenshots. - [ICF product tour](https://www.trelice.com/products/icf): Informed consent generation in depth. - [Pricing](https://www.trelice.com/pricing): Scoped to your trials; contact for a quote. - [Security](https://www.trelice.com/security): Regulatory standards and security practices. - [About](https://www.trelice.com/about): The team and the mission. - [Contact](https://www.trelice.com/contact): Book a demo. ## Documentation - [Documentation index](https://www.trelice.com/docs): Step-by-step guides for every part of Trelice. - [Welcome to Trelice](https://www.trelice.com/docs/welcome-to-trelice): The platform in plain words: study, protocol, sections, review, approval, amendment. - [Working with studies](https://www.trelice.com/docs/working-with-studies): Create studies, add sites and IRBs, start a protocol, or import one from Word or PDF. - [The protocol editor at a glance](https://www.trelice.com/docs/protocol-editor-overview): Sections, statuses, autosave, version history, and the live PDF preview. - [Filling in structured sections](https://www.trelice.com/docs/structured-sections): Form-based sections, the Schedule of Assessments, and automatic footnote numbering. - [Writing and formatting text](https://www.trelice.com/docs/writing-and-formatting-text): The text editor and automatic abbreviation insertion and expansion. - [Golden threads (cross-section consistency checking)](https://www.trelice.com/docs/golden-threads): How related protocol sections stay consistent, and the acknowledgment reviewers record. - [Comments and working together](https://www.trelice.com/docs/comments-and-collaboration): Field-anchored comments, presence, deep links to fields, and writer assignment. - [Sending a section for review](https://www.trelice.com/docs/submitting-for-review): Assign writers and reviewers, set due dates, and submit. - [Reviewing and approving](https://www.trelice.com/docs/reviewing-and-approving): The reviewer side: approve or request changes, level by level. - [Setting up review workflows](https://www.trelice.com/docs/review-workflows-and-approvals-setup): Multi-level review ladders and organization defaults. - [Your approval queue](https://www.trelice.com/docs/approval-queue): Everything waiting on one reviewer, in one place. - [Pending tasks](https://www.trelice.com/docs/pending-tasks): Outstanding work across all protocols, with built-in reminders. - [Your dashboard](https://www.trelice.com/docs/your-dashboard): Organization-wide study and review counts. - [Electronic signatures](https://www.trelice.com/docs/electronic-signatures): What signing means in Trelice and where the record lives. - [The audit trail](https://www.trelice.com/docs/audit-trail): The permanent, append-only activity log. - [Progress and audit reports](https://www.trelice.com/docs/progress-and-audit-reports): Per-protocol progress views and printable audit reports. - [Creating and editing an amendment](https://www.trelice.com/docs/creating-and-editing-amendments): Tracked changes with reasons, impact assessment, and site notifications. - [Amendment history and versions](https://www.trelice.com/docs/amendment-history): Frozen protocol versions and the downloadable summary of changes. - [The master consent form](https://www.trelice.com/docs/master-consent-form): ICF generation from the protocol, with reading-level checks. - [Translations and country versions](https://www.trelice.com/docs/translations-and-country-consent-forms): Twelve languages, language-specialist review, and country ICFs. - [The ICF Generator (from a PDF)](https://www.trelice.com/docs/icf-generator): Draft a consent form from an uploaded protocol PDF. - [Visit instructions and the subject booklet](https://www.trelice.com/docs/visit-instructions): Per-visit coordinator checklists and printable participant booklets. - [The eligibility screener](https://www.trelice.com/docs/eligibility-screener): Inclusion and exclusion criteria as an interactive screener. - [The IRB questionnaire](https://www.trelice.com/docs/irb-questionnaire): Ethics-committee answers built from the protocol, with source citations. - [The study schematic](https://www.trelice.com/docs/study-schematic): The generated study design diagram: arms, phases, and visits. - [The site budget](https://www.trelice.com/docs/site-budget): Per-country cost estimates computed from the Schedule of Assessments. - [Protocol templates](https://www.trelice.com/docs/protocol-templates): Reusable protocol outlines with writer roles, reviewer roles, and threads. - [Abbreviations, redaction, and budget pricing](https://www.trelice.com/docs/library-and-settings): The organization libraries behind abbreviations, redaction, and budgets. - [Roles and permissions](https://www.trelice.com/docs/roles-and-permissions): The 14 roles and what each can see and do. - [Glossary](https://www.trelice.com/docs/glossary): Plain-English definitions of clinical trial and Trelice terms. ## Company status Trelice is live and in active testing with early clinical teams; the first paid design partner pilot is in progress.