Kit Dispensation report

In this report, you view dispensation information for one, several, or all subjects at a site. The report lists the kits that were dispensed to a subject at each event in the study, throughout the life of the study. This includes kit replacements of lost or damaged kits.

Additionally, the Kit Dispensation report contains details about each subject's current state, the projected dispensation event, as well as the principal investigator's full name.

Note:

If your study is designed to allow titrations, dispensing IoT-enabled devices managed with Oracle mHealth Connector or unscheduled visits, then this report also contains information about the kits designed for these features.

The report contains additional information about unblinded kits, including descriptions of the kit types and information about the calculated doses.

Run this report if you need to see all dispensation information in a single location.

Modes

Available in all 3 modes: Testing, Training, and Production

Permission required to run the report

Any user who's assigned the Run the Kit Dispensation Report permission can generate this report.

Filters

Filter Description
Location Choose a site or depot to include dispensation history for a single location, or choose All to view dispensation history for all locations.
Subject Number

Choose a subject to include only one subject's dispensation history, or choose All to include the dispensation history of all subjects.

If Undo Add Subject is used and the subject number is subsequently reused, then there will be two entries for that subject number within the report's Subject Number filter. Select both entries to ensure the currently active subject is included in your report.

Visit Title

(Available only if you select a subject)

Choose a visit to include only the kits dispensed during the visit.
File Type Choose the output type for the report:\
  • CSV
  • HTML
  • PDF

Field descriptions

Note:

Fields that don't have any corresponding values are marked as N/A in the report.
Initial Fields Description
Customer Name A customer's name used to purchase the cloud subscription.
Study Name A study's ID as entered by the study manager when they created the study.
Mode The mode in which you ran this report. For example, you may run a report in Testing mode to verify the data of your sites before going live with your study.
Subject Number The number of the subject you selected to be included in the report.
Visit Title The name of the visit you selected to be included in the report.
Report Generated By User name of the user who ran this report (typically a training manager).
Created Date UTC time and date of the current generated report.
Location The location you selected for audit history, either a site or depot.
Fields in the table header Description
Site ID The site's ID as entered by the site manager when they created the site.
Site Name A site's name as entered by the site manager when they created the site.
Principal Investigator's Full Name A Principal Investigator's Full Name as listed when the site manager created the site.
Country A site's country as entered by the site manager when they created or last modified the site. Report displays country abbreviation.
Subject's ID Subject ID.
Subject's status A subject's status at the moment when this report was run. For example, a subject might be in an Active state or a New, Screened or Withdrawn state.
Subject's Randomization Number Unique number for the subject's randomization.

Note: If the Blind Randomization Number option in your study's settings is set to Yes, data for this field displays as Blinded. For more information, see Specify study, enrollment, and visits settings.
Fields in each subject section Description
Visit/Event title A visit's name. Includes unscheduled visits and events and branch visits.
Visit/Event Instance Indicates the unscheduled visit number or the branch visit instance for a subject.
Kit Number / Lot Number

A unique number assigned to individual/locally sourced kits (serialized kit distribution), or a grouped quantity of kits (non-serialized kit distribution).

The quantity appears next to a lot number for non-serialized kits only. For example, ABC345 (4).

Replaced Kit Kit number of the original kit in a replacement situation.
Dose Frequency Used in calculated dose designs (e.g. Once, QD, BID).
Titration Indicates whether a subject received any kit type titrations (for maintaining the dose, going up, or down).
Calculated Dose Displays information on the dose calculation unless the user running the report is blinded to this data.
Consume Units Across Doses A setting for calculated doses; it allows for minimization of waste when multiple doses are dispensed. Data may be blinded for some users running this report.

Note: For misallocated kits, this value is not calculated and displays as 'N/A'.
Kit Description Indicates a short description of each kit dispensed to a subject. Data for this column can be either visible or blinded based on role and study design.
Type The informational field for the packaging type (e.g. syringe, blister pack, ointment, activity watch).
Units per Kit Number of individual consumable units in a kit such as a pill count or mg.
Projected Dispensation Date Date when the next scheduled dispensation should take place in the study.
Dispensation Date Date of the kit dispensation in UTC format.
Reason for Change Where applicable, a user indicates a reason for change. Not all state changes require this additional comment.
Return Organization ID Indicates the ID of the site or depot a kit has been returned to. This field appears only when a kit is returned for a kit reconciliation shipment.
Return Organization Name The full name of the site or depot a kit has been returned to. This field appears only when a kit is returned for a kit reconciliation shipment.
Last Modified By Username of the user responsible for the latest update.

Parent topic: Report descriptions