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Category
Standard
Organisation
Standard
GS1 XML Clinical trials standard
Version
3.6
Access
Open
Status
Active
Updated
June 2023
This standard is the clinical trials component of the GS1 XML standards, designed to enable the exchange of information between different organisations, including the sponsor, distribution management entity, depot and clinical trial site. In-scope business message standard (BMS) messages include despatch advices, inventory reports, kit status changes, receiving advices, requests for inventory reports, dispensing advices, inventory release files, shipment confirmations, shipment notifications and shipment requests. For each message type, the standard includes:

• a publication package of business message standard documents that define the business solution

• schemas that contain the XSD files defining the message structure and content

• an instance file that contains XML instance sample messages

• an HTML sample that contains HTML representation of the SML instance sample messages.

The standard is supported by an implementation guideline that details best practice implementation of GS1 standards for electronic messaging in the pharmaceutical clinical trial supply chain.

Main sections (BMS packages for):

• despatch advices

• inventory reports

• kit status changes

• receiving advices

• requests for inventory reports

• dispensing advices

• inventory release files

• shipment confirmations

• shipment notifications

• shipment requests.
Access GS1 XML Clinical trials standard v3.6

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