Patient Safety

Individual Case Safety Report Release 2 Draft Standard for Trial Use

• Individual Case Safety Report Release 2 Draft Standard for Trial Use

The Individual Case Safety Report (ICSR) Release 2 Draft Standard for Trial Use (DSTU) Standard was approved at the January 2007 Working Group Meeting. FDA is sponsoring an ICSR DSTU Testing Project, and is considering the use of this wiki site as a resource to distribute information and track progress. Organizations interested in participating in the project should contact Lise Stevens, FDA via email at Lise.Stevens@fda.hhs.org and should also subscribe to the HL7 Patient Safety Special Interest Group list server to receive information about this project and other ongoing activities in PSSIG.

Armoire forte de sécurité