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Container unit

In IWRS, containers are hierarchical units used to group and manage investigational medicinal products (IMPs) and placebos for shipping and inventory purposes. They act as parent units for product units and are defined at different levels.

  • Level 1: represents parent product units, for example, medium box.

  • Level 2: represents parents of other containers, for example, large box containing medium boxes.

These containers serve as shipping units that enable the effective management of IMPs between depots and study sites, ensuring that products are properly categorized and tracked throughout their shipment lifecycle.

This part of the user guide explains how to:

Important

If no container units are configured under TREATMENT DESIGN > Container Unit, then all IMP handling—shipping, inventory, and so on—occurs in product units.

In this section:

A pharmaceutical form of active substances or placebos being tested or used as reference in clinical trials.

A substance or treatment designed to resemble the investigational product but has no therapeutic effect. It is used as a control to help researchers determine whether the actual drug or treatment is truly effective.

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.

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

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.