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| HDR Version 7 HL7 Version 3 Messaging Conformance Specification |
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This section contains the following topics:
4.13.1 Introduction 4.13.2 RMIM 4.13.3 State Transitions/Trigger Events 4.13.4 Interactions 4.13.5 Referenced CMETs 4.13.6 Links to Artifacts
The Individual Case Safety Report (Adverse Event Report) RMIM captures the information needed to support messaging adverse events, potential adverse events and product problems to regulators. This message supports both the reporting of this information from healthcare providers to agencies as well agency to agency reporting. In the United States, this encompasses reporting to the Food and Drug Administration (FDA) and medical device manufacturers. The Individual Case Safety Report (ICSR) message includes the information necessary to report reactions of regulated drugs, medical device failures, vaccine reactions, and product problems. Depending on the situation, the investigation will be associated either with information possibly related to a device or drug related reaction suffered by a patient, or with information related to a product (drug or device) problem.
The Individual Case Safety Report RMIM for version 6 is almost fully conformant to HL7 ICSR May 2005 ballot. Version 6 ICSR supports all the business processes that were supported by ICSR (Version 5 release). The processing of version 6 ICSR in HDR is same as processing of version 5 ICSR
The following figure diagrams the Individual Case Safety Report (Adverse Event Report) RMIM:
Figure: 4.13.2-1 Individual Case Safety Report (Adverse Event Report) RMIM
The list of trigger events follows:
Table 4.13.3-1 Individual Case Safety Report (Adverse Event Report) - Trigger Events| Begin State | End State | Trigger ID | Trigger Event |
| new | cancelled | PORR_TE040003UV01 | Withdraw ICSR notification |
| new | cancelled | PORR_TE040006UV01 | Cancel Product Defect Report Notification |
| new | new | PORR_TE040002UV01 | Revise ICSR Notification |
| new | new | PORR_TE040005UV01 | Revise Product Defect Report Notification |
| null | new | PORR_TE040001UV01 | ICSR Notification |
| null | new | PORR_TE040004UV01 | Product Defect Report Notification |
Note: ICSR Trigger event codes are defined in the HL7TriggerEventCode coding scheme. |
The list of Interactions follows:
Table 4.13.4-1 Individual Case Safety Report (Adverse Event Report) - Interactions| Interaction ID | Trigger Event | Transmission Wrapper | Control Act Wrapper |
| PORR_IN040001UV01 | PORR_TE040001UV01 | MCCI_MT000100HT04 | MCAI_MT700200HT01 |
| PORR_IN040002UV01 | PORR_TE040002UV01 | MCCI_MT000100HT04 | MCAI_MT700200HT01 |
| PORR_IN040003UV01 | PORR_TE040003UV01 | MCCI_MT000100HT04 | MCAI_MT700200HT01 |
| PORR_IN040004UV01 | PORR_TE040004UV01 | MCCI_MT000100HT04 | MCAI_MT700200HT01 |
| PORR_IN040005UV01 | PORR_TE040005UV01 | MCCI_MT000100HT04 | MCAI_MT700200HT01 |
| PORR_IN040006UV01 | PORR_TE040006UV01 | MCCI_MT000100HT04 | MCAI_MT700200HT01 |
| Artifacts | Link |
| Visio File | porr_rm040001ht01.vsd |
| Visio XML File | porr_rm040001ht01.xml |
| Hierarchical Message Description (HMD) | |
| Schema | porr_mt040001ht01.xsd |
| Model Interchange Files (MIF) | porr_mt040001ht01.mif |
| Side Effect Configuration Spreadsheet (for use in WebADI) | |
| Interaction Schemas | porr_in040001uv01.xsd porr_in040002uv01.xsd porr_in040003uv01.xsd porr_in040004uv01.xsd porr_in040005uv01.xsd porr_in040006uv01.xsd |
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