Future ICSR Specification and Related Files  

In May 2005, a revised guideline for Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports (E2B(R3)) was released for public consultation.  The ICH Steering Committee has 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 ICSR 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 have 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:

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

It is envisaged that at some time in the future the standard would be extended by the addition of other Parts applicable to different product types.

 

The standards mentioned above have reached Draft International Standard level and were balloted between April and September 2009 through national standards bodies and within the same timescales by HL7, CEN and CDISC. Significant comments were received from the ballots and a revised Draft International Standard has now been developed. It is being balloted for two months in ISO and CEN (from July 15, 2010 to September 14, 2010) and in parallel within HL7 and CDISC. This ballot will be the last opportunity in the process to amend the technical basis of the standard. Only editorial comments will be accepted after this ballot.

 

The Draft International Standards themselves may be accessed on the ISO website but it is considered that there is sufficient information included in the ICH documents to allow assessment in the context of production of ICSRs compliant with E2B(R3)

Proposed Use of the ISO ICSR Standard in ICH

 

ICH proposed to use this standard to meet the reporting requirements for E2B(R3). ICH will define the way that this standard should be used by the publication of an 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, 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, it produced a set of documentation 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 testing plus comments received, together with changes in line the Draft International Standard are reflected in an updated ICH Implementation Guide (version 2.47).

This guide is being made available for feasibility testing. Comments on this are sought during the period July 12, 2010 until August 12, 2010. Comments that affect the standard itself will be incorporated in the ICH consolidated comments for submission to ISO. Comments that affect only the Implementation Guide will be addressed in a revised version of the ICH Implementation Guide. The ICH Implementation Guide will then go through the usual ICH Step 3 consultation for a period more typical for ICH consultations. It is anticipated that this will start in November 2010.

There are significant differences between the data models for E2B (R2) and E2B(R3) and two documents have been produced which define the compatibility of data elements between the two version of the specification. In addition, stylesheets for conversion of E2B(R2) messages to E2B(R3) messages and vice versa have been developed. Comments are also invited on these documents and tools.

Documents available for feasibility testing
To download the package click here

The closing date for comments is August 12, 2010 but the documents will remain available on this page for awareness until they are superseded by revised versions for public consultation.

The documents comprise

The conversion stylesheets can be extracted from

and example data from

Additional documents are provided for information

Provided to allow awareness of how ICH will be testing the standard but also as a basis for others to undertake complimentary testing

Please fill your comments in this comment form and send it to icsr@estri.org

 

Last Updated:July 26, 2010