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Site inventory

In a clinical trial, sites are the locations that cover various study activities intended for subject treatment and data collection. One such activity managed via IWRS is dispensation—the process of providing subjects with items. To satisfy this process, there is a need to request, ship, maintain, and account for items.

Inventory page for site
Figure 1. Inventory page for site

For your convenience and efficient management of site inventories, the item statistics are given from three different perspectives—by summary, lot, and item—as explained in detail in the following sections.

Site inventory by summary

Under the By Summary tab, the statistics are given for all items accounted for in a site. The data can be organized by product units or container units based on your study configurations.

Important

If no container units are configured in IWRS, then all operations in Inventory occur in product units.

The inventory summary provides you with the complete picture of how many items or containers of different product are there in a site. Each value in the table that is not zero is an active link for you to navigate to the By Item tab for more detailed statistics.

Site inventory by summary
Figure 1. Site inventory by summary

In the following table, you can find the description of each element of the By Summary tab.

Element

Details

Shipping Unit/Product

Switch between these filters to display the inventory statistics either by both shipping units (containers and products) or only by products.

This filters are only available if container units are configured for your study.

Category

Represents one of the following:

  • Product: the item is a preconfigured product unit, the name of which you can see in the Item Unit column.

  • [Container category]: the item is a container unit. The container category names are configured upon adding container units to the system, for instance, Large Box and Medium Box.

Item Unit

Represents the name of the product.

The item units are not displayed for container units as they are enclosed within the container.

Expiry Buffer (Days)

Represents the buffer period in days set for the shipment of the product or container unit to prevent untimely drug expiry.

You can set the shipment buffer via the TREATMENT DESIGN > Supply Setting functionality.

Total Number Shipped to Site

Represents the total number of product or container units shipped to the site by its suppliers.

Total Number at Site

Represents the total number of product or container units that are currently at the site in various dispositions excluding the items of the Destroyed disposition.

Select this number to go to the By Item tab where the statistics for the selected item unit are displayed.

Available

Represents the number of product or container units that are available for dispensation or shipment.

Select this number to go to the By Item tab, where the statistics for the selected item unit are displayed and filtered by the Available disposition.

Expired

Represents the number of expired product or container units.

Select this number to go to the By Item tab, where the statistics for the selected item unit are displayed and filtered by the Expired disposition.

Lost

Represents the number of lost product or container units.

Select this number to go to the By Item tab, where the statistics for the selected item unit are displayed and filtered by the Lost disposition.

Quarantined

Represents the number of quarantined product or container units.

Select this number to go to the By Item tab, where the statistics for the selected item unit are displayed and filtered by the Abnormal group of disposition.

Damaged

Represents the number of damaged product or container units.

Select this number to go to the By Item tab, where the statistics for the selected item unit are displayed and filtered by the Abnormal disposition.

Pending Disposal

Represents the number of product or container units that have to be returned or are ready to be destroyed.

Select this number to go to the By Item tab, where the statistics for the selected item unit are displayed and filtered by the Pending Disposal disposition.

Dispensed

Represents the number of product or container units that have been dispensed and now obtain one of the following statuses: Dispensed (in Subjects), Dispensed (Wasted), or Dispensed (Returned).

Select this number to go to the By Item tab, where the statistics for the selected item unit are displayed and filtered by the Dispensed disposition.

In Transit

Represents the number of product or container units that are currently transferred from a supplier depot or elsewhere.

Select this number to go to the By Item tab, where the statistics for the selected item unit are displayed and filtered by the In Transit disposition.

Returned

Represents the number of product or container units that are returned to the supplier by the site.

Select this number to go to the By Item tab, where the statistics for the item unit are displayed and filtered by the Returned disposition.

Destroyed

Represents the number of product or container units that are destroyed by the site.

Select this number to go to the By Item tab, where the statistics for the item unit are displayed and filtered by the Destroyed disposition.

Important

There can be more columns in the table if any custom item dispositions are created for your study.

Site inventory by lot

A packaging lot is a batch of items that can belong to different product units but are collected into one package to be released (shipped) to the site or for other logistic purposes. Thus, it is very convenient to have the inventory statistics organized by lots, so that to analyze how many items of each lot are accounted for in the depot.

The data in the By Lot table can be organized by product units or container units based on your study configurations.

Important

If no container units are configured in IWRS, then all operations in Inventory occur in product units.

Site inventory by lot
Figure 1. Site inventory by lot

Each value in the By Lot table that is not zero is an active link that you can select to navigate to the By Item tab for more detailed statistics on the items of a certain disposition.

In the following table, you can find the description of each element of the By Lot tab.

Element

Details

Shipping Unit/Product

Switch between these filters to display the inventory statistics either by both shipping units (containers and products) or only by products.

This filters are only available if container units are configured for your study.

Category

Represents one of the following:

  • Product: the item is a preconfigured product unit, the name of which you can see in the Item Unit column.

  • [Container category]: the item is a container unit. The container category names are configured upon adding container units to the system, for instance, Large Box and Medium Box.

Item Unit

Represents the name of the product.

The item units are not displayed for container units as they are enclosed within the container.

Expiry Buffer (Days)

Represents the buffer period in days set for the shipment of the product or container unit to prevent untimely drug expiry.

You can set the shipment buffer via the TREATMENT DESIGN > Supply Setting functionality.

Lot Number

Represents the unique number of the packaging lot to which the product or container unit belongs.

Expiration Date of Lot

Represents the default expiration date of the packaging lot to which the item unit belongs.

Total Number Shipped to Site

Represents the total number of product or container units shipped to the site by its suppliers.

Total Number at Site

Represents the total number of product or container units that are currently at the site in various dispositions excluding the items of the Destroyed disposition.

Select this number to go to the By Item tab where the statistics for the selected item unit are displayed.

Available

Represents the number of product or container units that are available for shipment.

Select this number to go to the By Item tab, where the statistics for the selected item unit are displayed and filtered by the Available disposition.

Expired

Represents the number of expired product or container units.

Select this number to go to the By Item tab, where the statistics for the selected item unit are displayed and filtered by the Expired disposition.

Lost

Represents the number of lost product or container units.

Select this number to go to the By Item tab, where the statistics for the selected item unit are displayed and filtered by the Lost disposition.

Quarantined

Represents the number of quarantined product or container units.

Select this number to go to the By Item tab, where the statistics for the selected item unit are displayed and filtered by the Abnormal group of disposition.

Damaged

Represents the number of damaged product or container units.

Select this number to go to the By Item tab, where the statistics for the selected item unit are displayed and filtered by the Abnormal disposition.

Pending Disposal

Represents the number of product or container units that have to be returned or are ready to be destroyed.

Select this number to go to the By Item tab, where the statistics for the selected item unit are displayed and filtered by the Pending Disposal disposition.

Dispensed

Represents the number of product or container units that have been dispensed and now obtain one of the following statuses: Dispensed (in Subjects), Dispensed (Wasted), or Dispensed (Returned).

Select this number to go to the By Item tab, where the statistics for the selected item unit are displayed and filtered by the Dispensed disposition.

In Transit

Represents the number of product or container units for the item unit that are currently transferred from a supplier depot or elsewhere.

Select this number to go to the By Item tab, where the statistics for the selected item unit are displayed and filtered by the In Transit disposition.

Returned

Represents the number of product or container units that are returned to the supplier by the site.

Select this number to go to the By Item tab, where the statistics for the item unit are displayed and filtered by the Returned disposition.

Destroyed

Represents the number of product or container units that are destroyed by the site.

Select this number to go to the By Item tab, where the statistics for the item unit are displayed and filtered by the Destroyed disposition.

Important

There can be more columns in the table if any custom item dispositions are created for your study.

Site inventory by item

The By Item tab gives you detailed information on each item accounted for in a site inventory: its label package number, disposition, expiration date, and so on.

The data in the By Item table can be organized by product units or container units based on your study configurations.

Important

If no container units are configured in IWRS, then all operations in Inventory occur in product units.

Site inventory by item
Figure 1. Site inventory by item

In the following table, you can find the description of each element of the By Item tab.

Element

Details

Shipping Unit/Product

Switch between these filters to display the inventory statistics either by both shipping units (containers and products) or only by products.

This filters are only available if container units are configured for your study.

Item disposition filters

Select the needed tile (Available, Dispensed, In Transit, and so on) to filter the inventory by disposition and display only the pertaining product or container units.

Category

Represents one of the following:

  • Product: the item is a preconfigured product unit, the name of which you can see in the Item Unit column.

  • [Container category]: the item is a container unit. The container category names are configured upon adding container units to the system, for instance, Large Box and Medium Box.

Item Unit

Represents the name of the product unit. This is a blinded field, meaning that the value of this field is displayed as Blind unless the user has the Unblind View permission granted to them via the ADMIN application.

The item units are not displayed for container units as they are enclosed within the container.

Item Number

Represents the unique number of the product or container unit.

Sequence

Represents the sequential number of the product or container unit assigned to it in the system.

# of Unnumbered Item

Represents the number of unnumbered subitems within the item.

For instance, if an item is a vial of pills, the number of pills in a vial is the value for this column.

The number of unnumbered items is defined under the TREATMENT DESIGN tab via the Product Unit functionality.

The number of unnumbered items is not applicable to container units.

# of Subject Returned

Represents the number of unnumbered items returned by subjects and registered in the system under the SUBJECT tab via the Subject Dispensing functionality.

The number of returned subitems is not applicable to container units.

Lot Number

Represents the unique identifier of a packaging lot to which the product or container unit belongs.

Expiration Date

Represents the expiration date configured for the packaging lot and indicating when the product or container unit expires.

Manufacturing Lot Number

Represents the unique identifier of a manufacturing lot to which the product unit belongs.

Manufacturing Lot Expiration Date

Represents the expiration date configured for the manufacturing lot and indicating when the product unit expires.

This date exists in the system for the supply manager to check the item expiration date. However, for the system processes—for instance, the lot expiration alert setting—the packaging lot expiration date is accounted for.

Expiry Buffer (Days)

Represents the number of days set as an expiration buffer. The buffer period prevents subjects from getting and taking items that are about to expire.

If the current date is larger than the item's expiry date minus the expiry buffer days, the system marks them as expired.

[Unique ID Label]

Represents a unique identifier assigned to a subject to whom the items are dispensed or who returned the items.

The column name depends on the unique ID label configuration of your study.

Shipment Number

Represents the product or container unit's latest shipment number (or so-called shipment ID). Select the number to navigate to the corresponding shipment details page.

Disposition

Represents a current disposition of the product or container unit (open, available, in transit, expired, lost, and so on).

Tag

Represents the manually added tag, if any. Tags do not have any system logic, they are used as markers only.

Important

You cannot add tags to container units.

Comments

Represents a comment added to the product or container unit, if any.

In the site inventory by item, you can filter items by their disposition, manage the item disposition, view item information, pack or unpack containers, and view the item audit data following the same logic that applies to the depot inventory.

In this section:

Medical care given to a subject to mitigate or cure an illness, injury, or reduced health status. In a clinical trial, treatment may include prescribed drugs, biologics, devices, physical or psychotherapies, and such other procedures.

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.

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 product unit in the IWRS system is item unit.

container units

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.

container units

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.

The item numbers in a lot (batch) of item units that are used for tracking and assistance purposes.

In IWRS, an item disposition is the status of an item (drug) that represents its current state. For instance, Available, In Transit, Quarantined, and so on.

A hierarchical unit used to group and manage investigational products (IMPs) and placebos for shipping and inventory purposes. For example, large boxes and medium boxes.

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 (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.