Trials and Trial Groups

A Trial refers to a clinical trial. As defined in clinicaltrials.gov, clinical trials are research studies in which researchers assign participants to get one or more interventions to test what happens in people.

In CTIMS, a trial's eligibility criteria can be represented using the Clinical Trial Markup Language a.k.a. CTML format and saved in two different formats, yaml or JSON format.

CTIMS defines a "Trial Group" as a bunch of trials that are grouped together. They can be grouped based on the Principal Investigator (PI), the Pharma company, the curator, or any grouping to manage trials.

• Example Trial Groups names:

  • “DrSmithgroup”

  • “ParamountPharmaGroup”

  • “JohnCuratorGroup”

The trial group names used in CTIMS aides in trial management along with user management through Keycloak, as described in the Security and User management section.