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Subject scheduled dispensing plan

A subject dispensing plan outlines the procedures for administering a particular drug or treatment to human subjects in a clinical trial. When the visit dispensing is defined in IWRS, the system automatically creates a dispensing plan for subject visits in the EDC application. This subject dispensing plan is also reflected in IWRS and it indicates the drugs that must be dispensed to the subject during corresponding visits.

Important

The dispensing plan that does not apply to the particular subject in terms of treatment factors is not displayed under the Subject Scheduled Dispensing Plan tab. Therefore, it is possible that some visits are not included in a dispensing plan.

For example, treatment A is created for male subjects and treatment B is created for female subjects. Then for the female subjects, in the Subject Scheduled Dispensing Plan subtab, only visits for treatment B are displayed, whereas visits for treatment A are hidden.

The Subject Scheduled Dispensing Plan tab contains detailed information about each subject's dispensing plan. These details are explained in the following table.

Scheduled dispensing plans for subject
Figure 1. Scheduled dispensing plans for subject

Tip

Turn the Show N/A Dispensing toggle on or off to show or hide the dispensing plans that are currently not applicable for the subject based on the treatment group (cohort) to which they belong.

Reviewing the dispensation plans that are not applicable for the subject according to their current treatment becomes helpful in assessing the possibility of changing their dispensing plan with potential dosage decrease or increase, drug intake schedule change, and other adjustments.

Column

Details

Visit Name

Represents the name of the subject's visit during which the drugs need to be dispensed as defined in the EDC application. The visit name is the same for all the subjects in the study.

Visit Type

Represents the visit type defined for the subject's visit for a specific study in the EDC application.

Period

Represents the period defined for the subject's visit for a specific study.

Factor

Represents dispensing package's determining factors that have been configured for subjects.

Dispensing Package

Represents the name of the dispensing package.

The marking Package is not associated with the current version exclamation_mark_triangle_yellow.png indicates that the dispensing package set for the visit is not associated with the currently effective visit setting version. This can happen if the dispensing package was set before the association changed and now, you need to fix it manually by updating dispensing plan and changing the dispensing package.

Alternative Packages

Includes the list of dispensing packages that can be used as an alternative to the main dispensing package.

Scheduled Date

Represents the date when the dispensation is scheduled to occur.

This date is set according to the scheduled date of the dispensing window configuration.

Earliest Date

Represents the earliest date of the dispensing window when the dispensation may occur.

This date is set according to the earliest date of the dispensing window configuration.

Hard Earliest Date

Represents the earliest hard date of the dispensing window when the dispensation may occur.

This date is set according to the hard earliest date of the dispensing window configuration.

Latest Date

Represents the latest date of the dispensing window when the dispensation may occur.

This date is set according to the latest date of the dispensing window configuration.

Hard Latest Date

Represents the latest hard date of the dispensing window when the dispensation may occur.

This date is set according to the hard latest date of the dispensing window configuration.

Dispensing Date

Represents the date and time according to the timezone of the site in which the dispensing has occurred.

Status

Represents the status of the dispensing plan, which can be any of the following:

  • Not Started: the dispensing plan is not implemented on the subject yet so you can change the dispensing package of such dispensing plans.

    The current date is before the earliest dispensing date.

  • Ongoing: the dispensing plan is currently in progress.

    The current date is between the earliest dispensing date and the latest dispensing date.

  • Overdue: the dispensing plan has not been completed before or at the latest dispensing date.

    The current date is after the latest dispensing date.

  • Completed: the dispensing plan is implemented on the subject and you can no longer change the dispensing package of these plans.

Active

Represents the dispensing plan activation state:

  • Yes: the dispensing plan is active and you can provide subjects with their treatments according to this plan and record dispensations in IWRS.

  • No: the dispensing plan is inactive and cannot be executed in terms of dispensation.
See also
In this section:

An eClinical application that is mainly used to collect and manage subject data during clinical trials. It integrates with the Study Designer (SD) application and uses preconfigured there case report forms (CRFs) to complete data collection and management. It also provides an audit trail, data alert, source data verification (SDV), payment management, adjudication, and other functions as well as supports data export according to the CDISC ODM standard.

Get to know all the possibilities of the app with the comprehensive EDC User Guide.