Trialflare definitions

For those new to Trialflare, it can help to first understand the meaning behind some of our key concepts. Visitors from services such as REDCap will recognise some of the terminology below.

Teams

A "team" is the top-level concept in Trialflare. It represents an entire organisation, department, or just a group of people working together. In most cases, it is the team's responsibility to maintain a Trialflare licence.

A team contains users (i.e. the people that belong to your organisation or department - often your colleagues) and trials (the research projects run by your team).

A team is managed by team admins.

See more in the Team section of this help centre.

Trials

In Trialflare, a "trial" is a container for your project. It maintains forms (stages), variables (data types), participants, sites, arms (groups), packs, documents (TMF/site files), and more.

Teams typically have one or more trials at any one time, each with a set of users as trial personnel to manage the study.

Data types

In a Trialflare trial, a data type is a container for a piece of data you'll collect. These can be thought of as "variables".

Trialflare offers a range of different kinds of data types you can use (text, numeric, measurements, dates, and more). When building your forms ("stages"), you'll refer to the data types that sit behind your stage.

Stages

A stage is essentially a form. Stages can be participant-facing (e.g. for ePRO scenarios) or coordinator-facing (e.g. for CRF/HCP/at-site scenarios), or both. Stages can also be made made public, so that they can be used as polls, screening questionnaires, or other types of surveys.

Stages are formed from questions (each backed by a data type, as described above) in addition to non-question fields (such as titles or section dividers).

Stage groups

A stage group is a collection of stages. These are useful for bundling forms together for specific needs (e.g. "Visit 1 Forms").

Documents

The documents area of your trial is a place to manage the files relating to the project -- both at the trial and site level. Traditionally one might refer to this as the Trial Master File (a term we now try and avoid) or Site File system.

Use documents to correctly version your files and manage approvals.

Sites

As the name suggests, "sites" represent the physical or virtual spaces involved in your trial. They can be clinics, offices, or other locations that participants might attend or be associated with, or used to otherwise structure information flows in your trial.

Participants

The people involved in your study. These can either represent simple identifiers (e.g. to contain data in CRF-only studies) or as participant "accounts" (in ePRO or hybrid studies).