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Cohort

In a clinical trial, a cohort refers to a group of participants (subjects) who share certain characteristics or experiences and receive specific treatment over some time.

Upon entering a certain study period, subjects must be allocated to the preset cohorts according to the inclusion criteria and then, according to the randomization scheme, divided into treatment arms. Therefore, to properly set up IWRS for your study, you need to create cohorts and establish their inclusion criteria, and then add arms for each cohort.

In this section:

In IWRS, a period is a study phase in which the subjects are grouped and randomized. The Period functionality in the application is the main unit of the configuration of the subject randomization process.

The period configuration is a complex process of defining the screening conditions (factors) and cohorts of subjects that are further assigned to different arms according to the randomization scheme.

These are the key characteristics of the target population that researchers will use to answer their research questions. Typical inclusion criteria include demographic, clinical, and geographic characteristics.

A scheme (plan) according to which subjects enrolled in a study are randomized and receive their treatment.