E2B(R3) electronic transmission of Individual Case Safety Reports (ICSRs) implementation guide: data elements and message specification
- Collection:
- Health Policy and Services Research
- Series Title(s):
- Guidance for industry
- Contributor(s):
- United States. Department of Health and Human Services, issuing body. United States. Food and Drug Administration, issuing body. Center for Drug Evaluation and Research (U.S.), issuing body. Center for Biologics Evaluation and Research (U.S.), issuing body.
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, April 2022
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Adverse Drug Reaction Reporting Systems Drug and Narcotic Control Electronic Mail United States United States. Department of Health and Human Services United States. Food and Drug Administration
- Genre(s):
- Technical Report
- Abstract:
- This document is a guide for implementing the standard adopted by the ICH1 for electronic transmission of Individual Case Safety Reports (ICSRs) according to the ICH E2B(R3) message standard. This Implementation Guide (IG) was jointly developed by the ICH E2B(R3) and M2 Expert Working Groups (EWGs). The E2B(R3) EWG provided business requirements and the M2 EWG provided technical content for this IG. These two EWGs were reconstituted as the ICH E2B(R3) EWG in November 2010. Conceptually, an ICSR is a report of information describing adverse event(s) / reaction(s) experienced by an individual patient. This ICH IG focuses on medicinal products and therapeutic biologics for human use. However, the ICH is aware of other regional applications of the messaging standard that have a wider scope, such as pharmacovigilance activities related to vaccines, herbal products, cosmetics, veterinary products or medical devices. The primary ICH application is for the exchange of pharmacovigilance information between and among the pharmaceutical industry and regulatory authorities. This IG is also intended to support the implementation of software and tools for creating, editing, sending and receiving electronic ICSR messages. This IG is not intended to serve as a reference for proper pharmacovigilance practices nor is it intended to explain the underlying scientific or medical issues that support the collation, categorisation or analysis of medicinal product safety information. It is also not intended to explain the rationale that underlies proper case safety reporting. The focus of this ICH IG is on technical implementation. Thus, the intended audience includes system developers, IT professionals, system implementers and system users who need to understand the technical requirements for constructing and using valid electronic messages to transmit ICSRs. This IG provides the information necessary to support the development of adequate informatics tools (e.g. forms and interfaces for end user data entry) as well as technical requirements to design style sheets, conduct data transformations and code well-formed messages. However, this IG does not provide or infer guidance or recommendations for any particular database technology or software platform. Instead, this IG describes the technical requirement to generate valid XML code according to the standard outlined in this IG. Subsequent sections of this IG provide explanatory text concerning the business context for electronic ICSR messaging, including ICH documentation, and application to pharmacovigilance transactions.
- Copyright:
- The National Library of Medicine believes this item to be in the public domain. (More information)
- Extent:
- 1 online resource (1 PDF file (159 pages))
- Illustrations:
- Illustrations
- NLM Unique ID:
- 9918469488506676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918469488506676