A.1.5.2 (SERIOUSNESSDEATH) Should Not Be Set To '1' If Patient Death Is Unrelated To The Reported Reaction(s) On The Events Tab
Last updated on JULY 14, 2014
Applies to:Oracle Argus Safety - Version 4.2.1 and later
Information in this document applies to any platform.
Checked for relevance 30-JUL-2013
In Argus, if the Patient tab death information is unrelated to the reported reaction(s) on the Events tab, then the seriousness criterion in the data element A.1.5.2 (SERIOUSNESSDEATH) should not be flagged as '1' (results in death).
According to the updated EudraVigilance business rules for processing and validating ICSR messages document under Appendix C: Business Rules (Complete list) Note 9. SERIOUSNESSDEATH and REACTIONOUTCOME we have the following statement:
“If the death is unrelated to the reported reaction(s), only the section patientdeath (ICH E2B(R2) B.1.9) should be completed. The outcome of the reaction(s) reported in the data element reactionoutcome (ICH E2B(R2) B.2.i.8) should not be ‘fatal’ and the seriousness criterion in the data element (ICH E2B(R2) A.1.5.2) should not be flagged as ‘results in death’.”
Details for this EMA E2B guideline update may be found here (Click here):
(Look for the documents with the Title of “Implementation plan for the ‘Note for guidance - EudraVigilance Human – Processing of safety messages and individual case safety reports (ICSRs) (EMEA/H/20665/04/Final Rev. 2)” and “Note for guidance Eudravigilance Human - Processing of safety messages and individual case safety reports (ICSRs)” for further information from EMA)”.
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