Pega Pharmacovigilance is a modularized application that manages a range of life sciences processes, for example, the data capture of adverse events and product complaints for particular drugs.
If a medical device entity is involved as a suspect in an adverse event, the Outbound module generates an eMDR report and a report subcase to which the eMDR report is attached. The report subcase captures the event data and the case is mapped and copied to the eMDR page in the PegaLS-FW-AECPFW-Int-PORR_IN040001UV01 class.
When the data is copied, the Property-Set-XML method generates the output XML stream. The GenerateeMDRReport activity in the PegaLS-FW-AECPFW-Work-Reports class manages this process. This activity contains methods that call other modular activities that populate data for entities. For example, the PrepareReporterDataForeMDR activity populates Reporter entity data from the case to the eMDR page.
eMDR reporting includes three levels of acknowledgements. File listeners update the status of the report by processing the incoming acknowledgements. Each acknowledgement includes a Ticket and an SLA. For details, see the following table:
|Acknowledgement||Listener name||Ticket name||SLA|
When the GenerateeMDRReport activity generates an eMDR report, the report awaits the initial acknowledgement. In this stage, the report is routed to the OutboundSafetyAdminWB work basket and is further processed when the acknowledgement is received. The file listener parses the XML file when an acknowledgement is received. The activities that are defined in the the service file trigger a ticket that moves the flow to the following stages:
- Received-ESG – triggered by the ProcessAck1 activity after the initial acknowledgement is received
- Received-Agency – triggered by the ProcessAck2 activity after the second acknowledgement is received
- Resolved-Completed/Resolved-Failed – triggered by the ProcessSubmission activity after the third acknowledgement is received
After the report is resolved, a notification email is sent to the Outbound Safety Admin.
For details about the process flow of eMDR reports, refer to the DeviceReportProcess flow in the PegaLS-FW-AECPFW-Work-Reports class.
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