Glossary

Plain-English explanations of every clinical-trial and Trelice term used in these guides.

Every clinical-trial and Trelice term used in these guides, in alphabetical order, explained in plain English. When another guide links a word, the link leads here.

• 21 CFR Part 11: the American regulation (from the FDA) that says how electronic records and electronic signatures must work in clinical research. Trelice follows it for you: it keeps a permanent record of every action and asks for your password when you sign something.
• Amendment: a formal, tracked change to a protocol that has already been approved. An amendment states what is changing and why, and goes through review before it takes effect. Approved protocols are never quietly edited.
• Approval queue: the page in Trelice (menu item Approval Queue) that lists the sections currently waiting for your approval. Think of it as your personal review inbox.
• Audit trail: the permanent, unchangeable log of everything that happens in Trelice: every edit, approval, sign-in, and download, with who did it and when. Regulators require this record; Trelice writes it automatically.
• CRO (contract research organization): a company a sponsor hires to run parts of a clinical trial on its behalf, such as monitoring sites or managing data.
• Electronic signature: a legally meaningful signature made in the software instead of on paper. In Trelice, signing asks for your password again, so the signature can only be yours.
• Eligibility criteria: the rules that decide who may join a study: conditions a person must meet (inclusion criteria) and conditions that rule a person out (exclusion criteria).
• Endpoint: a thing the study measures to answer its question, for example, blood pressure after 12 weeks. Endpoints are what the statistics of the study are built around.
• Entitlement (product): a part of Trelice your organization has paid for, such as protocol authoring or consent forms. Features outside your organization's entitlements simply do not appear on your screen.
• Ethics committee: see IRB below; the two names mean the same kind of body.
• Export job: what Trelice creates when you ask for a PDF or Word download. Big documents take a little time to build, so the export runs in the background and shows a progress bar; when it finishes, you download the file.
• Golden thread: a Trelice check that related sections of a protocol still agree with one another, for example, that the endpoints and the statistical plan match. When they drift apart, a warning appears until someone looks and confirms or fixes it.
• ICF: short for informed consent form; see Informed consent form below.
• ICH E6 (Good Clinical Practice): the international standard for how clinical trials should be run and documented. Trelice's 21 standard protocol sections follow its structure.
• IND (Investigational New Drug application): the application a sponsor files with the FDA before testing a new medicine in people in the United States. A study's IND number is part of its details in Trelice.
• Indication: the disease or condition a treatment is being studied for.
• Informed consent form (ICF): the document a study participant reads and signs before joining a trial. It explains, in everyday language, what the study involves, its risks and benefits, and the person's rights. Trelice drafts it from your protocol.
• Investigator: the doctor responsible for running the study at a site. The lead doctor at a site is the principal investigator.
• IRB (Institutional Review Board): an independent committee that reviews a study before it starts, to protect the people taking part. Outside the United States, the same body is usually called an ethics committee.
• Pending task: any piece of work in Trelice that is waiting on a person: a section to write, a review to give, an approval to make. The Pending Tasks page gathers them all in one list.
• Phase: the stage of testing a treatment is in, from small first-in-human studies (Phase 1) through large confirmatory studies (Phase 3) and studies after approval (Phase 4).
• Protocol: the detailed plan of a clinical trial: who can join, what treatments are given, what is measured, when, and how the results will be analyzed. Writing, reviewing, and approving the protocol is the heart of Trelice.
• Redaction: blacking out confidential details, such as commercial secrets or personal data, in a copy of a document before it is shared publicly. Administrators set the redaction rules once; after that, a redacted copy is one click at export time.
• Review level: one rung in a review workflow. Everyone at level 1 reviews first; when they have all approved, level 2 begins, and so on. Only the active level's reviewers are asked to act.
• Review workflow: your organization's named recipe for who reviews a section and in what order, for example: medical experts first, then regulatory affairs. Administrators set workflows up once, and sections then follow them.
• Role: the job title attached to your Trelice account, such as Medical Writer or Investigator. Your role decides which pages and buttons you see.
• Schedule of Assessments: the table at the core of a protocol showing which tests and procedures happen at which visits. Each row is a procedure, each column is a visit, and a tick means: this happens then.
• Section: one topic-sized piece of a protocol or consent form, such as Study Design or Risks and Discomforts. Sections are written, reviewed, and approved one at a time.
• Site: a hospital or clinic where the study actually takes place and participants are seen.
• Sponsor: the organization responsible for the study, usually the company or institution paying for it and filing it with regulators.
• Structured section: a section that is a form rather than free text: you fill in labelled boxes, and Trelice can then reuse those answers elsewhere, in the consent form, the schematic, the budget, and more.
• Template: a reusable protocol outline. Starting a protocol from a template gives it your organization's preferred sections and settings instead of the standard set.
• Tenant (organization): one customer organization inside Trelice. Your studies, users, and documents belong to your tenant, and no other organization can ever see them.
• Therapeutic area: the broad medical field a study belongs to, such as cardiology or oncology.
• Translation review: the check of a translated consent form by a language specialist, a person qualified in that language, before the translation can be approved for use.
• Version: a frozen, numbered snapshot of a protocol, kept forever. A new version is created at each approval, so you can always see exactly what was in force at any point in time.

Note: If you meet a term in Trelice that is not listed here, check Common questions and problems, or start from Welcome to Trelice, the guides introduce every term the first time they use it.