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View inventory accountability details

The Inventory Accountability Details report in the IWRS application provides comprehensive statistics per item at your study sites and depots. However, the details of this report are intended for blinded users as the item unit information is not disclosed. With this data, for each item, the supply managers can track current disposition, location—site or depot, reconciliation status, and other details useful for statistical analysis.

Important

In Inventory Accountability Details, you only see the item units that are packaging for unnumbered items and for which the subject return is required.

To view this report, you must have the Inventory Accountability Details permission granted to your user role via the ADMIN application.

To view the inventory accountability details

  1. In the IWRS application header, select the REPORT tab.

  2. On the page that opens, in the left pane, select Inventory Report > Inventory Accountability Details.

  3. In the Inventory Accountability Details table that opens, view the quarantine items details as explained in the following table.

    Viewing inventory accountability details
    Figure 1. Viewing inventory accountability details

    Tip

    From the workspace toolbar, select Visible Columns columns_icon.png to choose the columns you want to show or hide from the report before viewing it.

    Column

    Details

    Item Number

    Represents the unique identification number of the item.

    Item Unit

    Represents the unit (name) of the item, for instance, Vitamin C.

    Item Type

    Represents the type of packaging that the item is, for instance, a vial or a blister.

    Item Disposition

    Represents the current item status at the inventory of the current item location—site or depot—for instance, Available, In Transit, Ready for Destruction, or else.

    Location Identifier

    Represents the unique identification number of the current item location—site or depot.

    Location Name

    Represents the name of the current item location—site or depot.

    Location Type

    Represents if the current item location is Site or Depot.

    Lot Number

    Represents the unique identification number of the packaging lot to which the item belongs.

    Expiration Date

    Represents the expiration date of the item that is the same as the packaging lot to which the item belongs.

    Subject ID

    Represents the unique identification number of the subject to whom the item is dispensed.

    Count by Site

    Represents the number of items in a packaging counted by the clinical research coordinator (CRC) when it was returned by the subject.

    Monitor Count

    Represents the number of items in a packaging counted upon site inventory reconciliation by the monitor—most commonly clinical research associate (CRA).

    Monitor Reconciliation Status

    Represents the status of the item set by the monitor—most commonly CRA—upon site inventory reconciliation. It can be one of the following:

    • Not Reconciled: the status represents that the reconciliation was not performed.

    • Complete: the status represents that reconciliation is completed and the item is finalized to one of the conclusions—Ready for Destruction or To be Returned.

    • With Exception: the status represents that reconciliation is completed partially and not all items in packaging can receive their conclusion.

    Site Reconciled by

    Represents the name of the user who performed site inventory reconciliation.

    Depot Reconciliation Count

    Represents the number of items in a packaging counted by the monitor at the depot upon performing depot inventory reconciliation.

    Depot Reconciliation Status

    Represents the status of the item set by the monitor upon depot inventory reconciliation. It can be one of the following:

    • Not Reconciled: the status represents that the reconciliation was not performed.

    • Complete: the status represents that reconciliation is completed and the item is ready to be destroyed by the depot.

    • With Exception: the status represents that reconciliation is completed but not all items from the packaging are intended for destruction.

    Depot Reconciled by

    Represents the name of the user who performed depot inventory reconciliation.

You have viewed the inventory accountability details. You can also export the report data to work with it offline.

In this section:

In eClinical, a unit of a drug that is being tested in a clinical trial is referred to as an item.

In a clinical trial, a location where the subject treatment and drug dispensation occur. It can be a hospital, a private laboratory, or other institutions.

A warehouse that is used to store and distribute items (drugs) to another destination (other depots or sites).

An investigational product that is used in a study. In eClinical, it can be viewed as an equivalent to a drug name to distinguish items at all stages of their lifecycle—manufacturing, shipment, dispensation to subjects, or else.

Another name for the item unit in the IWRS system is product unit.

In eCLinical, a status of an item (drug) or a subject (study participant) that represents the current state or stage of participation in a trial.

For instance, the item dispositions can be Available, In Transit, Quarantined, and so on. And the subject dispositions can be Registered, Enrolled, Screen Failure, and so on.

See also: item disposition

A process of confirmation that the items (drugs) intended for destruction are indeed eligible to be destroyed and in the established quantity.

For instance, after the subject treatment ended, they returned a vial of unused tablets which the site now has to dispose of. The clinical research coordinator (CRC) counts that there are 15 tablets left and marks those in the IWRS system as ready for destruction. Then, the clinical research associate (CRA) comes to the site to validate the calculations done by CRC on the leftover drug and verify that the amount of items to be destroyed is correct. This process of validation is called reconciliation.

An eClinical application that represents an administrative system used to manage users, authorities, and sponsors at the company level. It provides studies, sites, and sponsors with high-granularity role-based access management across all eClinical applications.

A batch of items collected into one package for shipment or other logistic purposes. Using packaging lots with their unique lot numbers gives depots and sites the ability to differentiate between different batches of drugs to track, for instance, release and expiration dates or other useful information.

A person responsible for the successful planning, execution, and management of clinical trials. The CRC’s scope of work might include study preparation, site setup, patient recruitment, regulatory compliance control, data collection, and more.

In the eClinical system, the Clinical Research Coordinator (CRC) user role is granted to a person who works on a site with subjects and is responsible for entering data to EDC, ensuring the data is entered correctly according to all requirements, and answering queries from data managers on any questionable data pieces.

A person responsible for overseeing and monitoring a clinical trial to ensure it is conducted in compliance with regulatory standards and protocols. The CRA’s scope of work might include protocol review, site selection and initiation, monitoring, data entry control, and more.

In the eClinical system, the Clinical Research Associate (CRA) user role is assigned to a person who works with the sites, and in EDC, mainly has to make sure that the entered data is truthful to the source document. CRA checks the source document in a process called source data verification and ensures that everything entered by the clinical research coordinators is valid to avoid any discrepancies caused by human errors.