Clinical Trials

Clinical Trials – Despatch Advice

The Despatch Advice (also known as the Advanced Shipping Notice) is designed to allow a shipper to provide information about the content of a shipment to a receiver. In the context of a clinical trial, this is advice to the site or depot that they will receive the logistics unit(s) labelled with Serial Shipping Container Code(s).

This Dispatch Advice Business Message Standard is one part of a suite of documents designed to provide the detailed technical mappings to GS1 message formats for EDI messages being implemented for Clinical Trials.

Clinical Trials – Inventory Report

The Inventory Report is used to communicate current levels of inventory of items within a given location. In practice, this message has two functions:

• Providing information on where inventory “is” at any point in time
• A way of communicating back how much inventory each actor has

This Inventory Report Business Message Standard is one part of a suite of documents designed to provide the detailed technical mappings to GS1 message formats for EDI messages being implemented for Clinical Trials.

Clinical Trials – Kit Status Change

The Kit Status Change is designed to convey an instruction to make a change in kit status or to confirm a kit status has changed. This Kit Status Change File Business Message Standard is one part of a suite of documents designed to provide the detailed technical mappings to GS1 message formats for EDI messages being implemented for Clinical Trials.

Clinical Trials – Receiving Advice

The objective of the Receiving Advice message is to send a notification that the good(s) were received (when compared to the good(s) shipped). There must be a one-to-one match between the Despatch Advice and Receiving Advice.

This Receiving Advice Business Message Standard is one part of a suite of documents designed to provide the detailed technical mappings to GS1 message formats for EDI messages being implemented for Clinical Trials.

Clinical Trials – Request for Inventory Report

The Request for Inventory Report communicates a request for provision of an inventory report, which gives current information about inventory levels. The inventory report request is related to finished products as identified GTINs.

This Request for Inventory Business Message Standard is one part of a suite of documents designed to provide the detailed technical mappings to GS1 message formats for EDI messages being implemented for Clinical Trials.

Dispensing Advice

The Dispensing Advice is used to communicate information related to the specific Investigational Products (IP) assigned to patients within the trial. This Dispensing Advice Business Message Standard is one part of a suite of documents designed to provide the detailed technical mappings to GS1 message formats for EDI messages being implemented for Clinical Trials.

Inventory Release File

The Inventory Release File is used for the initial release of IP kits or other serialised medication and to communicate this to stakeholders. The term ’release’ means ‘release for clinical use’.

This Inventory Release File Business Message Standard is one part of a suite of documents designed to provide the detailed technical mappings to GS1 message formats for EDI messages being implemented for clinical trials.

Shipment Confirmation

The Shipment Confirmation is sent from the depot back to the DME and confirms that an order will be or has been processed. This message includes many of the order specifics, including the supplies on the order.

This Shipment Confirmation Business Message Standard is one part of a suite of documents designed to provide the detailed technical mappings to GS1 message formats for EDI messages being implemented for clinical trials.

Shipment Notification

The Shipment Notification is the acknowledgment of the Shipment Request message. The Shipment Notification should be sent by the recipient once the Shipment Request message is received by the recipient.

This Shipment Notification Business Message Standard is one part of a suite of documents designed to provide the detailed technical mappings to GS1 message formats for EDI messages being implemented for Clinical Trials.

Shipment Request

The Shipment Request message is used to request the shipment of goods in any of the following scenarios: Serialised directed picking or free picking (blinded, open-label non-serialised or open label serialised).

This Shipment Request Business Message Standard is one part of a suite of documents designed to provide the detailed technical mappings to GS1 message formats for EDI messages being implemented for Clinical Trials.