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What is a ‘backward forward convertor’ ?



Did you know that ICH has a backward forward conversion (BFC) tool which was build using eXtensible Stylesheet Language Transformation (XSLTs) ? This language basically transforms a XML file of a given format into another XML file of a different format. The BFC tool requires a program that understands XSLT language to make conversion of E2B (R2) to E2B (R3) and vice versa. Now considering this, the European medical agency has improvised the BFC tool with additional fields as per the EU implementation guide. The EU version of the amended BFC tool has been published on the EMA website.

The key files in the BFC package includes downgrade-icsr.xsl; which downgrades E2B (R3) file into E2B (R2) and upgrade-icsr.xsl; which upgrades E2B (R2) file into an E2B (R3) file. The acknowledgement convertors include downgrade-ack.xsl and upgrade-ack.xsl
What are the technical limitations of BFC tools?

However, the conversion using BFC has some major limitations.

When converting ICSR from E2B (R2) into E2B (R3), the BFC rule maps units (units used in laboratory investigations in reference ranges & results) from the R2 lists, which in turn uses the Unified Code for Units of Measure (UCUM) list. However the list of UCUM units are limited, thus during the conversion if a unit is not mapped then BFC would indicate the unmapped unit using curly brackets {…} hence generating an error.

Similarly, when downgrading an ICSR from E2B (R3) to E2B (R2), extensive information loss may be incurred. Many E2B (R2) fields have limitations in the number of characters that are smaller than E2B (R3) fields. As an example, E2B (R2) narratives have a limitation of 20,000 characters which may cause an issue when downgrading from E2B (R3) file: this limitation in character may lead to the use of truncated symbols like $ * ? inside the narrative. A 10 page case narrative entered in E2B (R3) format would be truncated when converted into E2B (R2) format using BFC as (R2) has a limitation of up to 6 pages of text, thus leading to data loss and loss in quality of the individual case safety reports.

How are BFC tools used for E2B (R3) transmission and what are the alternatives?
Even though these limitations exist, a large number of MAHs / CROs are implementing BFCs in order to be able to import ICSRs from the new EudraVigilance system, as they have not yet upgraded their safety database to an E2B (R3) compliant solution.

However, implementing a BFC tool incurs high additional costs and long work for testing and updating procedures.Moreover, these costs cannot be offset on the long term as BFCs are only temporary solutions, which will not be accepted by the EMA any more in the long run.
We at Think I are committed to provide cost effective & robust pharmacovigilance solutions. Therefore, we chose to opt for a fully E2B (R3) compliant database, rather than investing in an expensive and unreliable BFC as a patch solution.

Think I partners with AB Cube to provide SafetyEasy PV™, a fully E2B (R3) native pharmacovigilance database. SafetyEasy PV™  is a fully evolutive and pre-validated database, hosted and delivered under the SaaS model (Software as a Service) via full web access. Of course, SafetyEasy PV™ also remains fully E2B (R2) compliant and able to manage submissions in R2 format..
AB Cube’s unique model enables us to propose a database which evolves regularly to propose new functionalities and guarantees adaption ahead of any regulation change, with no additional cost charged to our clients for the upgrades.


References:
1.WHY DO YOU NEED A NATIVE E2B (R3) PHARMACOVIGILANCE SOFTWARE ?; AB Cube Platform, Regulatory News; Url: https://www.ab-cube.com/need-native-pharmacovigilance-software/; Last accessed on 12.02.18

2.EudraVigilance change management Url:http://www.ema.europa.eu/ema/index.jsp curl=pages/regulation/q_and_a/q_and_a_detail_000165.jsp&mid=WC0b01ac0580a69263 ;
3.Trainingmodule:Implementing ISO ICSR/ICH E2B(R3); Url: http://www.ema.europa.eu/docs/en_GB/document_library/Presentation/2016/10/WC500214145.pdf ; Last accessed on 06.02.18
4. The Unified Code for Units of Measure; Url: http://unitsofmeasure.org/trac ; Last accessed on 06.02.18

An Article by:
Joseph Mathew
Senior Manager- Think i

For more details, contact us at +91 9560102587, +91 9810068241 or email us at medical@thinki.in   or simply visit www.thinki.in

                                                                                                                            

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