iSpeak Blog

Helping Companies Adopt Common Data Standards

Guidance Document Callout


Currently there are no standards or guidelines for system functionality that manage Investigational Medicinal Products (IMPs). Lack of standards for data and functionality has resulted in varying terminology, data formats, and controls, which can often make the selection, use, or interfacing of systems challenging.

The ISPE Good Practice Guide: Clinical Supply Systems  provides a detailed discussion of important areas of clinical supply system functionality, touching on key business requirements to assist interested parties with developing customized clinical supply applications or assessing commercial off the shelf systems for implementation. Examples and requirements for interfacing clinical supply systems involved in the management of IMPs with other internal or external systems are provided. The Guide also contains a list of proposed standard data terminology, along with frequently used equivalent terms, definitions of the data terms, and data formatting standards.

Download Appendix 2, which features common Electronic Data Interchange (EDI) Elements.