ISO ICSR(Individual Case Safety Report,个案病例安全报告)是一项用于提高药品疑似不良反应报告的新国际标准,该标准将于2016年7月1日生效。欧洲药品管理局(EMA)为支持这项新国际标准在欧盟(EU)的实施,近期发布了《个案病例安全报告实施指南》。
Description: The HL7 Individual Case Safety Report (ICSR) captures information needed to support reporting of adverse events, product problems and consumer complaints associated with the use of FDA regulated products.
ICSR Release 2 was completed December 2011 as an SDO Joint Initiative Project between the International Standards Organization (ISO), the European Committee for Standardization (CEN) and HL7. Information about the SDO Joint Initiative can be found at: http://www.jointinitiativecouncil.org/. The ICSR specification, ISO/HL7 27953 is a multi-part standard created to consolidate work efforts in ISO and HL7 as follows:
1. ISO new work item proposal N545: Health informatics - Pharmacovigilance - Structure and data elements of individual case safety report (reclassified as ISO 27953);
2. Health Level Seven (HL7) Individual Case Safety Report (ICSR) Release 1, Normative Standard;
3. HL7 ICSR Release 2, Draft Standard for Trial Use (DSTU)ISO/HL7 27953-1 (Part 1) is designed to address areas of overlap across the work items and form a messaging framework reference. This framework can be applied to support data exchange requirements described in the many different use cases presented as storyboards in this International Standard. This framework allows for future development work to be carried out so that additional use cases that are not currently addressed in this edition can be added in the future as new parts to this International Standard.