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Edit dispensing form settings

The Study Designer application has various tools to maintain different form settings. One such setting includes the indication of forms as intended for dispensation. The purpose of having dispensing forms is to streamline and automate the process of recording medication or treatment administration in the EDC system based on data generated from IWRS.

By integrating the dispensing case report form (CRF) with IWRS, data regarding the items administered to subjects can be automatically populated to EDC, reducing the likelihood of human error or manual data entry mistakes. As medications or treatments are dispensed to subjects, the relevant data is immediately captured on the form, providing up-to-date information on the dispensation status. This ensures that the recorded information is accurate, reliable, and consistent with the dispensation data stored in IWRS.

Dispensing form records with IWRS data
Figure 1. Dispensing form records with IWRS data

Important

This feature is available for any form of any type except for Grid icon_grid_form.png and Simple-Grid icon_simplegrid_form.png.

To edit the dispensing form settings

  1. In the Study Designer application header, select the CRF DESIGN tab.

  2. In the toolbar, select the latest draft CRF version marked with the respective unlock symbol unlocked_icon_purple.png, otherwise, you cannot perform any actions.

    Selecting latest draft CRF version
    Figure 2. Selecting latest draft CRF version

  3. In the left pane that appears, select the needed form.

  4. On the form content page that opens, select the Dispensing Form Settings tab.

    Important

    If this tab is not available, then open the tabs menu icon_tabs.png and select the Dispensing Form Settings checkbox.

    Viewing dispensing form settings
    Figure 3. Viewing dispensing form settings

  5. In the table that appears, you need to switch the Set as Dispensing Form toggle on to start configuring a form as dispensing.

    Configuring form as dispensing
    Figure 4. Configuring form as dispensing

  6. Then set a Dispensing Record Type by selecting one of the following options:

    • By item number: the form records will be generated in EDC for each separate item dispensed in IWRS.

    • By dispensing times: the form records will be generated in EDC for each time a bunch of items is dispensed in IWRS.

  7. Once the dispensing record type is specified, select and drag variables of the current form to dispensing field names available in IWRS to establish the mapping. This is done so the dispensing data in IWRS can be captured in corresponding fields on the form in EDC.

    The variables available for mapping are explained in the following table.

    Variable

    Details

    Item Number

    Represents the item number (also known as "labels") of the drug.

    Dispensing Date

    Represents the date when the drug was dispensed as recorded in IWRS.

    Dispensing Time

    Represents the time when the item was dispensed as recorded in IWRS.

    Dispensing Type

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

    Dose Assigned

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

    Dispensing By

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

    # of Unnumbered Item

    Represents the total number of subitems or unnumbered items that you want to return.

    For instance, in this context, a subitem can refer to the pill if an item is a medication bottle. The subitems are referred as unnumbered items because they aren't assigned ID numbers. Only the items have ID numbers.

    # of Subject Returned

    Represents the total number of items returned by the subjects during the visit.

    This information appears in this field only when user registers the return of items in IWRS.

    Return Date

    Represents the date when the item is returned by the subject.

    Return Time

    Represents the time when the item is returned by the subject.

    Lot Number

    Represents the lot number of the dispensed item.

    Expiration Date

    Represents the expiration date of the lot dispensed as recorded in IWRS.

    Replacement Item Number

    Represents the item number of the item replacement. This is only applicable if Replacement is chosen as the dispensing type.

    # of Subject Lost

    Represents the number of items lost by the subjects during the visit.

    Item Type

    Represents the type of the item, such as bottles, vials, and so on.

    Unnumbered Item Unit

    Represents the unit of the unnumbered items, such as tablets, capsules, and so on.

  8. From the workspace toolbar, select save_icon_red.png to save the dispensing form configuration.

Once saved, the form is set as dispensing and will collect data populated from IWRS after it is published to EDC.

In this section:

In eClinical, a process of providing a subject with medication at a visit to a site during their treatment in the course of a clinical trial.

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.

An eClinical application that represents unified and configurable subject randomization and trial supply management tool for subject grouping, drug inventories, shipments, and dispensations, as well as other vital processes during a clinical trial.

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

case report form (CRF)