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Site shipments

In a clinical trial, sites are locations where the subject treatment and item dispensation occur. To satisfy the site's dispensation needs, suppliers must ship items to them according to a specific supply plan.

Shipment is the action of transporting items (drugs) between depots and sites. In IWRS, you can decide how it is more convenient for you to handle the item logistics:

  • By product unit. Ship and request your products as individual instances, such as a vial of infusion liquid, stick of powder, blister of tablets, and so on.

    For instance, if your product is Aspirin in tablets packed in blisters, then a single blister of Aspirin is a shipping unit that you can request, dispatch, receive, and otherwise manage.

  • By container unit. Ship and request your products in packages of product units, such as a box containing a specific number of product units.

    For instance, if your product is Aspirin in blisters and you pack them into boxes of 10 blisters each, then a single box of Aspirin blisters is a shipping unit that you can request, dispatch, receive, and otherwise manage.

    Important

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

All the operations of shipment management for a specific site—dispatch and receipt—are handled from the dedicated Shipment subtab.

Site shipment list
Figure 1. Site shipment list

In the following table, you can find the description of all details available in Shipment List.

Column

Details

Shipment Number

Represents the system-generated shipment number.

Status

Represents the system-determined shipment status:

  • Draft: the new supply shipment has been created and saved for further use and amendments; no shipment request has been sent.

    The system-generated shipments also receive the Draft status so that users can modify them before sending the request to the supplier.

    You can enable the draft shipment request to control if the initial shipment request is created as a draft first and then requested by the personnel in charge or sent immediately, skipping the draft approval. If disabled, the Draft status is inapplicable for your study.

  • Requested: the shipment is requested.

  • In Transit: the shipment has been confirmed by the supply depot.

  • Cancelled: the draft shipment request has been canceled.

  • Revoked: the shipment has been revoked by the supply depot.

  • Lost: the shipment has been confirmed lost by the applicant's depot.

  • Quarantined: the shipment has been quarantined by the applicant's depot. This shipment is to be sent back to the return depot.

  • Damaged: the shipment has been confirmed as damaged by the applicant's depot. This shipment is to be sent back to the return depot.

  • Partial Received: the items in the shipment are partially received by the applicant's depot.

  • Received: the shipment has been fully received by the applicant's depot.

Type

Represents the system-determined shipment type:

  • Initial: the shipment is created when the initial shipment is triggered manually or by the system.

  • Manual: the shipment is created for requesting items.

  • Resupply: the shipment is created by the system when the item resupply is required.

Last Modified Time

Represents the date of the last shipment modification.

Origin

Represents the name of the shipment supplier—site or depot.

Destination

Represents the name of the site for which the shipment has been requested.

Service

Represents the shipment service that is entered by the user and used for logistics purposes.

Tracking ID

Represents the tracking ID of the shipment entered by the user.

Created Date

Represents the date when the shipment request has been created.

Dispatch Date

Represents the date when the shipment request has been dispatched.

Actual Receipt Date

Represents the date the shipment has been fully or partially received.

Item Status at Receipt

Represents the status of the received shipment. The status can be:

  • Available: the shipment is ready for distribution.

  • Damaged: the shipment is damaged and may not be distributed.

  • Quarantined: the shipment requires quarantine before distribution.

# of Items

Represents the number of items that the shipment contains.

Under the Shipment subtab, you can also do the following:

Important

To perform certain actions with site shipments, you must have the respective permissions granted to your user role via the ADMIN application.

ADMIN permissions to manage shipments
Figure 2. ADMIN permissions to manage shipments

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

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.

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 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.