Configuring Adverse Events Reporting

You can configure Adverse Events Reporting. See Properties for Adverse Events Reporting.

  1. Create or open the text file for customized properties. For more information, see Editing Properties Using MQL.
  2. To create a default route object between the Review and Submission approval states of the adverse event report (AER), follow these steps:
    1. Add or edit this line in the file used to import properties into a page object: 

      LPQComplaint.type_AdverseEventReport.EnableReviewProcess=True

    2. Set the value for this property depending on your business requirements.

      • True: Route object is created between the Review and Submission Approval states, and In Process and Invalid states of the AER.
      • False: Route object is not created.

  3. To provide host name or IP address of the server through which eMDRs are submitted to FDA, follow these steps:
    1. Add or edit this line in the file used to import properties into a page object: 

      LPOCPT.eMDR_FTP_Server

    2. Set the value for this property depending on your business requirements.
  4. To provide FTP directory name on host FTP server, follow these steps:
    1. Add or edit this line in the file used to import properties into a page object: 

      LPOCPT.eMDR_FTP_Directory

    2. Set the value for this property depending on your business requirements.
  5. To provide user name of FTP user, follow these steps:
    1. Add or edit this line in the file used to import properties into a page object: 

      LPOCPT.eMDR_FTP_Username

    2. Set the value for this property depending on your business requirements.
  6. To provide company name of the sender to be specified in the Individual Case Safety Report (ICSR) XML file, follow these steps:
    1. Add or edit this line in the file used to import properties into a page object: 

      LPOCPT.eMDR_Company_Name

    2. Set the value for this property depending on your business requirements.
  7. To provide Central File Number, which needs to be obtained by the company from Electronic Submissions Gateway (ESG), follow these steps:
    1. Add or edit this line in the file used to import properties into a page object: 

      LPOCPT.eMDR_Company_CFN_Number

    2. Set the value for this property depending on your business requirements.
  8. To provide the path where standard XSD file is placed, with which generated XML should be compiled before submitting to FDA, follow these steps:
    1. Add or edit this line in the file used to import properties into a page object: 

      LPOCPT.eMDRHL7.XSD_Validation_File_Path

    2. Set the value for this property depending on your business requirements.
  9. To provide unique network path in server environment where you want FDA eMDR acknowledgment files to be placed, follow these steps:
    1. Add or edit this line in the file used to import properties into a page object: 

      LPOCPT.eMDRHL7.FDA.Acknowledgement_Location

    2. Set the value for this property depending on your business requirements.
  10. When you are finished updating the text file with all properties that you want to modify, use the text file to modify the AdverseEventReport.properties page object. For more information, see Editing Properties Using MQL.