Introduction

Cohort management is used to model studies that cover multiple cohorts. Each cohort may be defined in terms of:

• visits,

• enrollment,

• patient treatment and

• discontinuation.

Cohorts are defined in a cohorts table. This table is used to:

• define cohorts,

• when they start and

• how many patients are forecasted to enroll into each cohort.

The defined cohorts can then be used in

• the visit schedule,

• the dispensing table,

• the randomization specification,

• the titration specification and

• the discontinuation specification.

Notes

The cohort functionality can be used to model pooled studies.

The cohort functionality can also be used to model roll-overs between studies, extension studies and weight-based dosing, but these models are better created using visit actions.

If cohorts are used in a specification and an enrollment table is used, the rules defined there apply.

Cohorts Table

Cohort Code

The cohort code is the identifier of a cohort which is used in other tables. Cohort codes must be unique. If a duplicate cohort code is entered, an error is shown.

In forecast calculations with RTSM data extracts, the cohort code specified in 4C Supply® must map correctly to the corresponding cohort code in the RTSM. This can be verified in the RTSM data extract mapping report.

Cohort Description

Cohort Description is free text to describe a cohort to readers of the specification. The specification of cohort descriptions is not mandatory and is not interpreted, but the column cohort description must be included in the cohorts table.

Cohort Start Date

Defines the date when enrollment into the cohort is forecasted to begin. Cohort Start Date must be a valid date.

In forecast calculations with RTSM data extract, the cohort start date specified in 4C Supply® is the forecasted start date of a cohort that is considered in the forecast calculation.

In forecast calculations with RTSM data extract, if patients in the RTSM data extract are enrolled in a cohort that has a start date after the RTSM extract date in 4C Supply®, then further patients will not be forecasted to enroll to the respective cohort until the start date defined in 4C Supply®.

In forecast calculations with RTSM data extract, if no patients in the RTSM extract are enrolled in a cohort that has a start date before the RTSM extract date in 4C Supply®, then patients will be forecasted to enroll in the respective cohort starting from the RTSM extract date.

Cohort Patient Cap

Defines the enrollment limit for the corresponding cohort.

In forecast calculations with data extract, the cohort patient cap specified in 4C Supply® is the overall enrollment cap of the respective cohort.

In forecast calculations with data extract, if a cohort that is closed in the RTSM still has potential enrollment in 4C Supply®, then 4C Supply® will still forecast enrollment into the respective cohort.

If a cohort that is open in the RTSM has reached its cap in 4C Supply®, then no future patients will be forecasted to enroll in this cohort.

Example Cohorts Table

Cohorts table

In RED are Mandatory Attributes