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Category
Standard
Organisation
Standard
GS1 Clinical Trial Application Standard
Version
1.1
Access
Open
Status
Active
Created
February 2019
Updated
June 2021
This standard published by GS1 presents general principles and rules about the use of the GS1 keys and attributes for the identification of investigational products in healthcare clinical trial processes. The standard includes principles for the traceability and identification of investigational products and barcoding. It includes identification rules, Global Trade Item Number (GTIN) management rules and barcoding rules. It also presents a set of technical data standards.

Main contents:

• Introduction

• References

• Terms and definitions

• Traceability of investigational products

• IP identification and barcoding principles

• Identification rules

• GTIN management rules

• Barcoding rules

• Technical standards
Access Identification of Investigational Products in Clinical Trials Application Standard v1.1

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