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Cohort enrollment management

Subjects in a trial are allocated to different cohorts previosly configured for your study to receive different treatments based on their specific factors. In IWRS, you can manage subject enrollment for each cohort and set limitations for different dosages to ensure the right number of participants allocated to treatment groups for the most efficient result of your investigation.

The details of each column available under the Cohort Enrollment Management page are explained in the following table.

Cohort enrollment management in IWRS
Figure 1. Cohort enrollment management in IWRS

Column

Details

Period Name

Represents the name of the period to which the cohort belongs.

Cohort Name

Represents the name of the cohort.

Limit of Enrollment

Represents the subject count currently set as a cohort enrollment limit (if any).

# of Enrolled Subjects

Represents the actual subject count currently enrolled in a cohort. This value does not count the discontinued subjects. If the cohort enrollment limit is set for the cohort, the following indicators appear next to this value:

  • check_mark_green.png: indicates that the actual subject count currently enrolled in a cohort is less than the set enrollment limit, and more subjects can be allocated to this cohort.

  • exclamation_mark_red_icon.png: represents that the actual subject count currently enrolled in a cohort equals the set enrollment limit, and subject allocation for this cohort is ceased.

Status

Represents one of the following cohort statuses:

  • Draft: the default status of the newly configured cohort, subject enrollment has not been initiated yet.

  • Ongoing: subject enrollment is initiated for the cohort.

  • Stopped: subject enrollment is halted for the cohort.

  • Closed: subject enrollment is ceased for the cohort.

To change the status, expand the dropdown list and select the needed one. In the Status Change Reason dialog that appears, provide the reason for your action and select save_button.png.

Providing reason for cohort status change
Figure 2. Providing reason for cohort status change

Dosing Factor

Represents the cohort inclusion criteria that must be selected for the subject upon changing their phase to randomization one for the subject to be enrolled in this cohort and receive certain medication dosages.

Dosage

Represents the name of the dosage given to the patient.

Limit of Dosage Enrollment

Represents the maximum number of subjects that can be enrolled into this cohort and receive certain medication dosage.

Current Subject #

Represents the total number of subjects currently enrolled in a cohort and receiving certain medication dosage.

Open

Represents whether the dosage is open for enrollment (Yes) or not (No).
In this section:

A group of subjects who share a set of specific factors (characteristics) that is first defined and composed, then studied or tracked over a given time period. In a clinical trial, outlining the study cohort begins with clearly defined, study-specific inclusion criteria.

In IWRS, factors are the conditions that influence subject randomization and drug dispensing.

For example, they determine to which cohort the subject is assigned, what treatment receives at a certain visit, and so on.

There are three types of factors in IWRS:

  • Treatment-specific: the value of the factor is set at each treatment.

  • Visit-specific: the value of the factor is set once at a visit.

  • Subject-specific: the value of the factor is set once for a subject.