GS1 Pharmaceutical Clinical Trial Electronic Messaging Standard Implementation Guideline

This guideline details the best-practice approach to implementing GS1 standards for electronic messaging in the pharmaceutical clinical trial supply chain. It helps resolve issues related to the lack of a standard for data exchange within the clinical trials environment and the potential data quality issues and supply chain disruptions that can occur as a result. This document helps to align the standards for data and information exchange with the direction of other industries, particularly the commercial healthcare supply chain.

This document is part of a suite of documents designed to guide readers on why and how to implement GS1 standards for electronic messaging. It defines the messages in scope, business-critical dataset and relevant business rules. Separate documents contain the detailed technical mappings to GS1 message formats.

Main sections:

· Benefits of implementation, business opportunity and business needs

· Purpose

· Scope

· Business processes and messages

· Implementation considerations

· Clinical trial specific considerations

· Messages description, use case & data fields