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Automated Safety and Acknowledgement Message Validation
and Processing
The EudraVigilance Gateway routes messages to the EVDBMS when the
EMA is specified as the receiver in the message. The processing
of these messages in the EudraVigilance DBMS is a completely automatic
and a multi-step process. The same principles apply to the validation
and processing of medicinal product report message. Click
here for more information about the EVMPD.
Step one is the Document Type Definition (DTD) validation with the
aim of checking if the message instance is according to the ICH ICSR
DTD, which defines each element of the ICSR being transmitted, and
reflects how the various data elements are related to each other. Within
the encoded text, the DTD specifies which elements are required and
the order in which they appear.
The Safety Messages are checked in accordance with the integrity and
consistency rules, inside and outside the ICH M2 specification with
the ultimate goal of detecting if the field values are conforming to
the ICH-M2 specification and agreed standard terminology (such as MedDRA
and the EudraVigilance Medicinal Product Dictionary).
In step two the Safety Messages are checked in accordance with the
integrity and consistency rules, inside and outside the ICH M2 specification.
The ultimate goal is to detect if the field values are conforming to
the ICH-M2 specification and agreed standard terminology (such as MedDRA
and the EudraVigilance Medicinal Product Dictionary).
In step four the acknowledgement message, as defined within ICH M2,
is automatically prepared by the EudraVigilance DBMS in order to communicate
to the sender the results of the outcome of the validation of the transmitted
data set.
The stepwise approach and the applied validation and business rules
are defined in detail in the Technical Documentation, Note for Guidance
- EudraVigilance Human version 7.0 Processing of Safety Messages and
Individual Case Safety Reports (ICSRs)
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Last update: Tuesday, 20 June 2006.
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