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Subject dispensing

Subject dispensing refers to the process of assigning a specific treatment or medication to a study subject. Once a subject has been assigned to a treatment group, the appropriate medication or treatment is dispensed to them based on the study protocol. In the IWRS system, the dispensation of drugs to each subject occurs depending on the randomization result.

Once the subjects have been assigned a specific item, the dispensation can start. The process of dispensing medication to study participants happens via adding visits to the subject dispensing plan beforehand. After the visits have been added, you can start creating scheduled/unscheduled or manual dispensations.

Within the Subject Dispensing page, you can operate with dispensed items for a selected subject. The grid columns on this page are explained in the following table.

Subject dispensing list
Figure 1. Subject dispensing list

Important

Some of the columns displayed in the figure may not be visible if the Hide Item Number permission has not been assigned to you.

Column

Details

Visit Name

Represents the name of the visit during which the medication is dispensed to the selected subject.

Visit Type

Represents the type of a visit and can be one of the following:

  • Scheduled: a planned subject visit defined in the clinical protocol schedule of activities (SoA).

  • Unscheduled: a visit that is not defined in SoA but takes place when the subject requires it. Such visits are added manually to the system. However, if the study protocol predicts the need for unscheduled visits, they are added to SoA.

  • Common: a visit that is not the actual subject visit defined in SoA such as adverse events, prior, concomitant medication visits, and so on.

Dosing Factor

Represents the selected factor value for the subject dosing.

Dose Assigned

Represents the dispensing package assigned to the subject for the visit.

# of Items

Represents the total number of item(s) and their lot numbers that have to be dispensed to the subject at the visit.

# of Replaced

Represents the total number of item(s) and the lot number that has been replaced during the dispensation of the subject at the visit.

# of Wasted

Represents the total number of item(s) and the lot number that has been wasted during the dispensation of the subject at the visit.

# of Returned

Represents the total number of item(s) and the lot number that has been returned during the dispensation of the subject at the visit.

Dispensing Type

Represents the dispensing type selected by the user while dispensing medication to the selected subject. The types are as follows: Manual, Scheduled, Unscheduled, and Replacement (when the drug item has been replaced).

Dispensing Date

Represents the date and time according to the timezone of the site where the drug has been dispensed to the subject.

Operation Date

Represents the date and time of drug dispensing to the subject according to your timezone.

Dispensing By

Represents the name of the user who has dispensed items to the selected subject.

Comments

Represents the comment added by the user while creating the dispensation.

Is Backfilled

Indicates whether the drug dispensation has been distributed offline at the site (Yes) or in IWRS first (No).

Sync to EDC

Indicates whether the drug dispensation information has been synced to the EDC application. If not, you can sync to EDC manually.
See also
In this section:

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

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.

EDCEDC