I.C.3.3 Attachments.........................................................................................34
I.C.3.4 Use of local Language in Reaction/Event section and Case Summary section .........36
I.C.3.5 EU Causality Assessment Reporting in ICSRs ...............................................37
I.C.3.5.1 Data elements for Causality Assessments ..................................................38
I.C.3.5.1.1 EU Source of Assessment (EU E2B(R3) G.k.9.i.2.r.1.EU.1) ..........................39
I.C.3.5.1.2 EU Result of Assessment (EU E2B(R3) G.k.9.i.2.r.3.EU.1) ...........................39
I.C.3.5.1.3 Causality Assessment Example.............................................................40
I.C.3.6 Additional ISO/HL7 ICSR Data Fields for EU Regional Implementation .................41
I.C.3.6.1 Integration with ISO IDMP Standards .......................................................41
I.C.3.6.1.1 Use of UCUM units ............................................................................42
I.C.3.6.1.2 Medicinal Product Identifier (MPID) .......................................................42
I.C.3.6.1.3 Pharmaceutical Product Identifier (PhPID) ...............................................43
I.C.3.6.1.4 Product Name Parts ..........................................................................45
I.C.3.6.1.5 Substance/Specified Substance TermID..................................................47
I.C.3.6.1.6 Decision flow diagram for entering Medicinal Product Information..................48
I.C.3.6.1.7 Use of EDQM for Routes of Administration and Dosage forms .......................49
I.C.3.6.2 Biological Products requiring Batch Number ...............................................51
I.C.3.6.3 Device Component ..............................................................................51
I.C.3.7 Usage of nullflavor flags ..........................................................................53
I.C.3.8 Characterisation of Drug Role “Drug Not Administered” ...................................55
I.C.3.9 Literature references and the use of Digital Object Identifiers (DOI) ...................56
I.C.3.10 MedDRA Version control.........................................................................56
I.C.3.11 Guidance when only entering free text Medicinal Product names and substance
names..........................................................................................................56
I.C.4 Business Rules for E2B(R3) Message Processing .............................. 57
I.C.4.1 Business Rule Notes ...............................................................................86
I.C.5 The ICH Acknowledgment Message .................................................. 90
The acknowledgment message is an integral part of the exchange of ICSR messages, further
details on this exchange can be seen in section I.C.2.1 Electronic Data Interchange .........90
I.C.5.1 Acknowledgment Message Elements ...........................................................90
I.C.5.2 Parsing error message ............................................................................90
I.C.5.2.1 ICSR Message Cardinality checks ............................................................91
I.C.5.3 ICSR Message Acknowledgment Elements ....................................................91
I.C.5.4 Error/Warning message comments.............................................................91
I.C.5.4.1 Error / Warning Message or Comment (ACK.B.r.7).......................................92
I.C.5.4.1 Field Level error description list ..............................................................93
I.C.5.4.2 Field Pair Error description list ................................................................96
I.C.5.4.3 Section Level Error description list ...........................................................97
I.C.6 ICSR Classification............................................................................ 97
I.C.6.1 Classif ication algorithm ...........................................................................98
I.C.6.1.1 Nullification Reports .............................................................................98
I.C.6.1.2 Master Cases .....................................................................................99
I.C.6.1.3 Case clustering ...................................................................................99
I.C.6.2 Classif ication of Medicinal Product Information ............................................ 100
I.C.6.2.1 Classification of medicinal products in the interim period bef ore ISO IDMP is
available ..................................................................................................... 101