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The Individual Case Safety Report (ICSR) is a Health Level Seven standard for the capture of the information needed to support the reporting of adverse events, product problems or consumer complaints associated with the use of FDA regulated products. The HL7 ICSR will be used as the FDA baseline data exchange standard, and is currently being pilot tested to support FDA’s transition to a unified electronic environment for managing all FDA-regulated product information for adverse event reports, product and consumer complaints and product problem reports.
HL7 ICSR Release 1 was approved as an ANSI Standard in 2005, and is being piloted to support electronic medical device reporting (eMDR) for the FDA Center for Devices and Radiological Health (CDRH). Information about eMDR can be found at: eMDR – electronic Medical Device Reporting
HL7 ICSR Release 2 Draft Standard for Trial Use (DSTU) was approved by HL7 January 2007, and expands the scope of the 2005 release to support other product categories such as food, food additives, dietary supplements, cosmetics, veterinary drug products, and combination products. Additional changes to the specification have been made to accommodate new requirements based upon the experience of pilot testing ICSR Release 1. The ICSR DSTU can be downloaded from the HL7 DSTU Comments webpage at: http://www.hl7.org/dstucomments/index.cfm.
Several tools are under development or in use to facilitate FDA testing and for ICSR Release1 CDRH has developed a free downloadable application for low volume reporting. Please click the eMDR link for more information. FDA is partnering with GlobalSubmit on the development of XFORMs to facilitate Release 2 testing. FDA will continue to update its website for ICSR information and resources. Organizations interested in ICSR DSTU testing should contact Lise Stevens.
HL7 Individual Case Safety Report Release 1: Implementation Guide for FDA Medical Device Reporting
DIA 43rdAnnual Meeting - HL7 Individual Case Safety Report - Lise Stevens
DSTU Testing Registration Templates:
ICSR Testing Criteria Selection Chart
Detailed Test Plan Description