ICSR Public Consultation page

The ICH E2B EWG released the E2B Guideline for Maintenance of the ICH Guideline on Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports (ICSR) in 1997 and issued a revised version in 2000; a further minor revision was made in 2001 (version 4.4.1): this version was renamed as “E2B(R2) Guideline” later. ICH M2 EWG developed ICH ICSR DTD version 2.1 as a message specification for implementation of the E2B(R2) Guideline; this reached Step 4 in 2001. Since then, implementation of electronic submission of ICSRs based on these Guidelines has become widespread in the ICH regions.

ICH E2B EWG re-formed for a revision of E2B(R2) Guideline in 2004 and in May 2005, a revised Guideline, E2B(R3) was released for public consultation. The ICH Steering Committee had taken a key decision that technical specifications should no longer be developed solely within ICH, but should be created in collaboration with Standards Development Organisations (SDOs) to enable wider inter-operability across the regulatory and healthcare communities. The E2B(R3) is the first topic to go through this process.

The International Organisation for Standards (ISO), Health Level 7 (HL7) and European Committee for Standardization (CEN) have collaborated to form the Joint Initiative on SDO Global Health Informatics Standardization through which a single, common standard for the ICSR could be advanced. Subsequently, the Clinical Data Interchange Consortium (CDISC), the International Health Terminology Standards Development Organisation (IHTSDO) and GS1 have also become members of this Joint Initiative. ICH representatives had been heavily involved in this initiative in addition to other experts from beyond the ICH community. The overall standard is based upon the HL7 ICSR model that is capable of supporting a wide range of product types (e.g. human medicinal products, veterinary products, medical devices etc.) The framework is described in:

• ISO/HL7 27953-1 Health informatics -- Individual case safety reports (ICSRs) in pharmacovigillance -- Part 1: The framework for adverse event reporting

The second part of the standard defined the details of the reporting requirements for human pharmaceuticals :

• ISO/HL7 27953-2 Health informatics -- Individual case safety reports (ICSRs) in pharmacovigillance -- Part 2: Human pharmaceutical reporting requirements for ICSR

The standards mentioned above finally reached International Standard level and were published on the ISO webpage on 21 November, 2011. The Part 1 and Part 2 of the ICSR International Standards are separately available in downloadable format and CD on the ISO webpage with charges.

Use of the ISO ICSR Standard in ICH

ICH will use the ISO ICSR standard to meet the reporting requirements for E2B(R3). ICH defines the way that this standard should be used by means of the ICH Implementation Guide which covers the use of the fields defined by the E2B(R3). The ISO standard itself does contain some additional fields that are not used by ICH but may be used by specific regions. Such use, where appropriate, will be defined by regional Implementation Guides.

ICH Feasibility Testing

During the first ISO ballot of the Draft International Standard (DIS), the E2B(R3) and M2 Expert Working Groups of ICH undertook extensive testing against the ICH Implementation Guide and the ISO standard. In order to undertake this testing, they produced a set of documentation including ICH Implementation Guide (version 1.31) that was made available to the public to support testing by a wider group of stakeholders. ICH invited comment on the set of documentation until 22 July 2009. The results from the testing plus comments received, together with changes in line the Draft International Standard were reflected in an updated ICH Implementation Guide (version 2.47). This guide was provided to the public for feasibility testing which was taken place in parallel with the second DIS ballot in ISO. Comments on the guide were sought during the period July 12, 2010 until August 12, 2010. There were about 500 comments in total from outside and inside of ICH. A few comments that affected the ISO ICSR DIS standard itself were incorporated in the ICH consolidated comments for submission to ISO. Most comments that affected only the Implementation Guide were addressed in a revised version of the ICH Implementation Guide.

ICH Public Consultation

The ICH Implementation Guide has been further updated in order to provide sufficient information to readers and reached Step 2 in June 2011. This guide was published for public consultation (Step 3 of the ICH Process) in September 2011 with a deadline for comments until March 31, 2012.

There are significant differences between the data models for E2B (R2) and E2B(R3) and a Backwards and Forwards Compatibility (BFC) document has been produced as an appendix to the Implementation Guide which defines the compatibility of data elements between the two versions of the specification.

Step 2 document package
To download the package click here

The documents will remain available on this page for awareness until they are superseded by finalised Step 4 documents.

The document package comprises 4 materials. The main document is the ICH ICSR Implementation Guide which includes E2B(R3) data elements and message specifications; the BFC document is an appendix to the guide but being provided separately. The ICH ICSR XML schema set includes all necessity schema files for creating ICH ICSR messages and ICH Acknowledgement messages plus other reference schema files. The ICH ICSR reference instance is created to be aligned with these schemas and the ICH ICSR Implementation Guide. Although the same reference instance is included in the guide, it is provided separately as an xml file.

• Electronic Transmission of Individual Case Safety Reports Draft Implementation Guide - Data Elements and Message Specification (version3.01) (ICH_ICSR_Draft_Implementation_Guide v3.01.pdf)
• Appendix to the Implementation Guide : Backwards and Forwards Compatibility (version 1.00) (ICH ICSR BFC Specification v1.00.pdf)
• ICH ICSR XML Schema Set (version 20110615)
• ICH ICSR Reference Instances (version 1.0)

Additional documents are provided for information:

• Information Paper (E2B_R3_ Information Paper_28072011.pdf)
  This Information Paper explains the short history of E2B, relationship to ICH M5 and ISO IDMP standard, and ICH position on regional requirements for the exchange of ICSR messages.
  
• BFC materials
  The conversion rules between E2B(R2) and E2B(R3) messages are provided in the compatibility mapping spreadsheet. This is a base document of the BFC document above, and the conversion style-sheets are developed as implementation of these rules. The example data are not derived from the compatibility mapping spreadsheet, but presents differences in E2B(R2) and E2B(R3) messages. Note that the example files do not correspond to the upgrade and down grade of each other.

• Backwards and Forwards Compatibility Mapping (BFC Element Mapping v1_00.xls)
• E2B Conversion style-sheets (BFC Conversion Sheets v1_00.zip)
• Example data files (BFC UT Files v1_00.zip)
• ICH ICSR Reference Instances (version 2.0)* (ICH_Reference_Instances_v2_0.zip)
  These reference instances are updated version of ICH ICSR Reference Instances provided in the document package above, which include ICH OIDs rather than placeholder OIDs and some minor amendments.
• ICH OIDs and code lists (version 1.0)*
  ICH OIDs and related codes to be used in ICSR message are published and maintained by the M2 EWG.
• OID Information Paper (version 1.0)* (E2B(R3) OID Information Paper v1_0 CLEAN.pdf)
  This document explains about OIDs, UUIDs, and differences between ICH ICSR Implementation Guide version 3.01 and ICH OIDs and code lists version 1.0.
  

[This page was updated: September 12, 2011]
[Three materials (*) were added: November 29, 2011]
[This page was updated: April 2, 2012]