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Cohort list

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

All cohorts previously created in the IWRS application are displayed on the period configuration page, under the Cohort List subtab. The cohorts have the attributes explained in the following table.

Cohort list
Figure 1. Cohort list

Column

Details

Cohort Name

Represents the cohort name.

Randomized

Indicates whether the subjects included in the cohort are randomized or not.

Randomization Method

Represents one of the following randomization methods selected for the cohort upon configuration:

  • Permuted Block: this method involves the preparation of a randomization list before initiating the randomization process for the study. Randomization of subjects is first performed into blocks according to preset stratification factors and then into arms according to specific ratios.

  • Dynamic Randomization: this method adjusts the allocation probabilities based on the current distribution of participants. Thus, when each patient comes to the study, the system assesses their compliance with established factors, evaluates the existing patient groups and site imbalance, and allocates the new patient to the most imbalanced group. Unlike permuted block randomization, dynamic randomization does not involve the predefined randomization list and offers more adaptivity to achieve arm balance at all times.

Subject Replacement

Represents whether the subjects included in the cohort can be replaced or not. This field remains blank if the subject is not randomized.

Dosing Factor

Represents the condition under which the dosage is or has been given.

Open only one dosage at a time

Represents one of the following:

  • Yes: only one dosage parameter can be opened simultaneously when setting dosages for the cohort.

  • No: multiple dosages can be opened simultaneously when setting dosages for the cohort.

Opening only one dosage option can be convenient for dose escalation cohorts, where you need to go from the lowest dosage of the drug and gradually increase it, so you only want to allow one option for selection to avoid the mistreatment of patients with different dosages simultaneously.

You can set to open only one dosage at a time upon cohort configuration.

Lock the used dosage

Represents one of the following:

  • Yes: the dosage is locked after it has been once selected as a cohort dosing factor when setting dosages for the cohort.

  • No: the dosage remains open for selection after it has been already set as a cohort dosing factor when setting dosages for the cohort.

Locking the used dosage can be convenient for dose escalation cohorts, where once you have already treated the subjects with a lower dosage of the drug and increased it, you do not want to allow going back and decreasing the dosage.

You can set to lock the used dosage upon cohort configuration.

Description

Represents a description of the cohort.

Messages

Represents the text of the message that appears upon attempting to enroll the subject into the cohort if such confirmation is configured.

From the Cohort List page, you can perform the following actions:

In this section:

A participant who is enrolled in a clinical trial and assigned to the site.

A process during which subjects receive their random numbers and are assigned to different arms based on the randomization scheme.