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View blinded item audit report

The Blind Item Audit report of the IWRS application represents an audit trail for each item (drug) registered in the IWRS system. In other words, it stores data on all changes made to a particular item.

Important

To view this report, you must have the Blind Item Audit permission granted to your user role via the ADMIN application.

To view the blinded item audit report

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

  2. On the page that opens, in the left pane, select Inventory Report > Blind Item Audit.

  3. In the Blind Item Audit table that opens, view the audit trail details of each item available in the IWRS system as explained in the following table.

    Viewing audit trail of items registered in IWRS
    Figure 1. Viewing audit trail of items registered in IWRS

    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 identifier of the item for which the details are displayed.

    Status

    Represents the current status of the item in the site or depot inventory, such as Available, Ready for Destruction, Lost, and others.

    Lot Number

    Represents the unique identifier of the packaging lot to which the particular item belongs.

    Lot Expiration Date

    Represents the expiry date of the packaging lot to which the particular item belongs.

    Manufacturing Lot Number

    Represents the unique identifier of the manufacturing lot to which the particular item belongs. 

    Manufacturing Lot Expiration Date

    Represents the expiry date of the manufacturing lot to which the particular item belongs.

    Audit

    Describes the details of the action performed with the item with auxiliary information to help users track the needed instances.

    For instance, in the audit details for adding the item to the shipment, you can find the shipment number to further locate and track this shipment in the IWRS system.

    Comment

    Represents the comments and notes added by users to the item upon processing it in the system, for instance, upon releasing the item to the destination, changing item disposition in the inventory, or else.

    Destination Name

    Represents the name of the site or depot to which the item must be shipped. The value in this column is mainly needed for shipment auditing.

    Destination Type

    Represents the destination type of the item, such as Subject or Site.

    For example, if it is Subject, the drug must be dispensed directly to the subject. If it is Site, the drug must be shipped to the site and then dispensed to the intended subjects.

    Location Name

    Represents the name of the institution where the item auditing has taken place.

    For example, if the shipment auditing occurred at depot "A" before the item is shipped to site "001", then "Depot A" can be a location name, and "Site 001" can be named a destination.

    Location Type

    Represents the type of the institution—site or depot—where the item is currently stored or accounted for.

    For instance, if the item is currently in the Available status at the site inventory, its location is Site. However, if the item is being shipped to the site from the depot and its status is In Transit, the location of this item is currently Depot. That is because until received by the site, the item is accounted for at the depot.

    User Name

    Represents the name of the user who has performed the operation on the item.

    Action Time

    Represents the date and time when the operation has been performed on the item.

You have viewed the blinded item audit report. 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.

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.

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).

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 batch of items (drugs) produced together at one time. This information is not used for logistics purposes or system processes of IWRS but exists in the system for the traceability of manufactured drugs.

In eClinical, an action of transporting items (drugs) between depots and sites. Also, an instance that represents a bundle of items being shipped together as one batch with the same shipment number (identifier) and status.

See also: return shipment and supply shipment.

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.

A participant who is enrolled in a clinical trial and assigned to the site.