Welcome to Trelice

What Trelice is, the main ideas in plain words, and how a study becomes a finished protocol.

Trelice is a website where clinical trial teams write, review, and approve the documents a trial needs — above all the protocol, the detailed plan for the study. Instead of emailing Word files back and forth, everyone works on the same document, in one place, with a permanent record of every change.

You do not need to install anything. Trelice runs in your web browser, like online banking or webmail. If you can read email and click links, you can use Trelice.

The big idea: from study to approved protocol#

Work in Trelice follows one natural path. Here it is in plain words.

1. A study is created. A study is the container for one clinical trial — its number, its phase, its therapeutic area, its sites. See Working with studies.
2. A protocol is started inside the study. The protocol is the rulebook of the trial: who can join, what treatments are given, what is measured, and when.
3. The protocol is divided into sections. Each section covers one topic — for example the study design, the eligibility criteria, or the statistics. Writers fill in the sections one at a time in the protocol editor. Some sections are free text; others are structured sections — simple forms where you fill in boxes instead of writing paragraphs. See The protocol editor at a glance.
4. Each section goes through review. When a section is ready, the writer sends it for review. Your organization decides who reviews, and in what order, using a review workflow — for example, first the medical experts, then regulatory affairs. Reviewers either approve the section or ask for changes. See Sending a section for review and Reviewing and approving.
5. Approval is recorded with electronic signatures. Approvals can be signed electronically. Trelice asks for your password again at the moment of signing, so a signature really is yours. See Electronic signatures.
6. Changes after approval become amendments. An approved protocol is never quietly edited. To change it, you create an amendment — a formal, tracked change with a written reason, which goes through review again. Every past version stays available. See Creating and editing an amendment and Amendment history and versions.

That is the whole lifecycle: study → protocol → sections → review → approval → amendment. Everything else in Trelice supports this path.

What else Trelice builds for you#

Trelice fills in as much as it can from what you have already written, so you never type the same fact twice.

• Consent forms. Trelice drafts an informed consent form from your protocol, and helps you translate it and make country-specific versions. See The master consent form and Translations and country versions.
• Study documents. From your protocol's structured data, Trelice can build an eligibility screener, an IRB questionnaire, a site budget, visit instructions with a participant booklet (Visit instructions and the subject booklet), and a diagram of the study design (The study schematic).
• Exports. Any protocol or consent form can be downloaded as a PDF or Word file. Your organization's administrators can also set up redaction rules, so a version with confidential details blacked out is one click away. See Downloading PDF and Word documents.
• Consistency checks. Related sections must agree — the endpoints you promise must match the statistics that analyze them. Trelice watches these golden threads and warns you when sections drift apart.
• A complete record. Every action — every edit, approval, and sign-in — is written to the audit trail, a permanent log that cannot be changed. This is a regulatory requirement, and Trelice handles it for you automatically.

Why your screen may look different from a colleague's#

Two things decide what you see in Trelice.

Your role. Every account has a role, such as Medical Writer, Biostatistician, or Investigator. Your role decides which menu items appear and which buttons you can press. For example, only administrators see the Administration group in the left-hand menu. If a page or button described in these guides is missing for you, that is almost always your role — not a mistake. See Roles and permissions.

Your organization's products. Trelice features are sold in parts — protocol authoring, master consent forms, and country consent forms. Your organization only sees the parts its contract covers. If a whole area seems absent, your organization may simply not have that product.

Note: Trelice is built for regulated work. It follows ICH E6 (Good Clinical Practice) and 21 CFR Part 11 (the FDA rule on electronic records and signatures). You do not need to know these rules — the system applies them for you.

Where to go next#

1. Start with Signing in and your account to get into the system.
2. Then read Finding your way around for a tour of the screen.
3. Your dashboard explains the first page you see after signing in.
4. When a word is unfamiliar, look it up in the Glossary — every term in these guides is explained there in plain English.

Troubleshooting: If something does not behave as a guide describes, check Common questions and problems first. Most puzzles — a missing button, an unexpected sign-out — have a one-line answer there.