| Oracle® Device and Drug Adverse Event Data Integration Pack for Siebel Adverse Event Complaint Management and Oracle Argus Safety Implementation Guide Release 11.1 E26803-01 |
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PDF · Mobi · ePub |
| Oracle® Device and Drug Adverse Event Data Integration Pack for Siebel Adverse Event Complaint Management and Oracle Argus Safety Implementation Guide Release 11.1 E26803-01 |
|
|
PDF · Mobi · ePub |
This chapter discusses the steps you must complete to integrate data in Siebel AECM and Oracle Argus Safety PIP. It covers:
Configuration Properties for the Device and Drug Adverse Event: Siebel AECM and Argus Safety PIP
Updating Server Information for Siebel AECM and Oracle Argus Safety
Extending the Device and Drug Adverse Event: Siebel AECM and Argus Safety PIP
Configuring Multiple Siebel AECM Servers to a Single Instance of SOA Server
These are the prerequisites for this PIP:
You can customize the list of values for the fields in Siebel AECM and Oracle Argus Safety. DVMs are created to map the value in Siebel AECM that matches the value expected by the Oracle Argus Safety import feature. You must review and update the DVMs to match the values in your systems. For more information, refer to the section Working with Domain Value Maps.
If you have added any fields to Siebel AECM or to Oracle Argus Safety that you would like to send from Siebel AECM to Oracle Argus Safety, you must follow the steps that are available in the section Extending the Device and Drug Adverse Event: Siebel AECM and Argus Safety PIP.
Review and set the configuration settings for the integration appropriately for your business process. Refer to the section Configuration Properties for the Device and Drug Adverse Event: Siebel AECM and Argus Safety PIP for setting up the configuration properties.
This section discusses the data requirements. Data requirements indicate the mandatory data that you must provide to make the integration flows successful.
When a Product Issue is entered in Siebel AECM you must enter the data in the following fields before clicking the Send to Safety button. You will receive an error message from Siebel AECM, if the data is not entered in these fields:
Event Type
Report Type
Event Description
Awareness Date
Country of Incidence
At least one suspect product must be entered in the Product tab of the Product Issues screen.
If Study is entered for the Report Type, the following must be entered in the Patient tab:
Patient ID
OR any of the following:
Date of Birth
Gender
Age
This section describes how to set up Oracle Argus Safety and Siebel AECM to utilize the integration.
This section describes the tasks and general procedures that you must complete to set up Oracle Argus Safety.
The Argus Interchange feature requires some information to be entered in the Argus Console for the Frequency codelist. Therefore, before using the integration the Argus administrator must go to the Argus Console and navigate to the Frequency codelist.
For each value that exists in the codelist for Frequency, enter the following three fields:
Number of doses per day - Enter the number of doses to be taken each day.
Dose - Enter amount of dose to be taken each time.
Every N days (where you enter N) - Enter interval of dosage frequency (such as Every 2 Hours, Every 5 Days, Every 6 Weeks.
This section describes the tasks and general procedures that you must complete to set up Siebel AECM.
If Siebel AECM is used for adverse events with Medical Device or combination Drug/Medical Device products, the Language Independent Code (LIC) in Siebel AECM Tools for the Event Type pick list must contain the string device.
Ensure that your Siebel AECM administrator sets the LIC for the pick list options to contain the string device.
The Frequency field in Siebel AECM has a drop down list of values. The LICs must be defined in a particular format in order for the frequency to go over correctly to Oracle Argus Safety. The display values can be anything.
The LIC value must be in one of the following formats. Note that these formats are case sensitive:
Once a <unit of time>
Twice a <unit of time>
Thrice a <unit of time>
Once Every <n> <unit of time>
Twice Every <n> <unit of time>
Thrice Every <n> <unit of time>
<n> Times a <unit of time>
<n> Times Every <n> <unit of time>
Where <n> is any numeric value and <unit of time> is one of the following:
Minute or Minutes
Hour or Hours
Day or Days
Week or Weeks
Month or Months
Year or Years
Examples are: Twice a Day, Once Every 2 Weeks, 4 Times a Day, 3 Times Every 2 Months
For more information about how to set the Language Independent Code (LIC) in Siebel AECM, see Configuring Siebel Business Applications, Version 8.1, Rev. B, "Localizing Siebel Business Applications - Localizing a Multilingual List of Values".
If you are using Siebel Clinical and have defined Protocols in your application, you must enter the Study ID from Oracle Argus Safety for that study. Follow these steps to associate the Product Issue to the Study ID:
Navigate to Administration Clinical and select Protocols List.
Drill down to the Protocol and click More tab.
Scroll down to the Integrations section of the screen.
Enter the Oracle Argus Safety Study ID in the Safety System Study field.
This ensures that Oracle Argus Safety connects the case that is created for the Product Issue to the correct study.
For more information about the integration processes setup and configuring Siebel Adverse Event and Complaint Management system for integration with Oracle Argus Safety, see the Siebel Life Sciences Guide, Version 8.1.1.6.
This section contains a table that describes the field mapping between Siebel AECM to Oracle Argus Safety and lists all the data that is sent from Siebel AECM to Oracle Argus Safety.
| Siebel AECM | Oracle Argus Safety |
|---|---|
| Product Issues Screen Fields | |
| Country specified in the Address chosen for the Primary Contact of the Product Issue | Case Form / General/ Reporter Information/Country |
| Product Issue Country of Incidence | Case Form / General/General Information/Country of Incidence |
| Product Issue Report Type | Case Form/General Information/Report Type |
| If any of the seriousness checkboxes are checked this will be 'Y' | Case Form/ Analysis/ Case Serious |
| Death checkbox under Reported Outcome of Event | Case Form / Analysis / Case Serious / Notes |
| Life Threatening checkbox under Reported Outcome of Event | Case Form / Analysis / Case Serious / Notes |
| Hospitalization checkbox under Reported Outcome of Event | Case Form / Analysis / Case Serious / Notes |
| Disability or Permanent Damage checkbox under Reported Outcome of Event | Case Form / Analysis / Case Serious / Notes |
| Cogenital Anomaly or Birth Defect checkbox under Reported Outcome of Event | Case Form / Analysis / Case Serious / Notes |
| If value filled in for Other Serious under Reported Outcome of Event | Case Form / Analysis / Case Serious / Notes |
| Awareness Date | Case Form / General/General Information/Initial Receipt Date |
| Last Followup Date | Case Form/General/General Information/Followups/Follow Up Date |
| Reported FDA | Case Form/Reporter Information/Report Sent to Regulatory Authority by Reporter?(Note this will be set for first reporter only) |
| Product Issue # | Case Form/Additional Info/References/ID |
| Related Product Issue # | Case Form/ Additional Info/ References/ID |
| Reporter Qualification | Case Form/General /Reporter Information/Reporter Type |
| Product Issue Contact Division | Case Form/ General Information/ Reporter Information/ Department |
| Product Issue Contact Organization | Case Form/ General Information/ Reporter Information/ Institution |
| Product Issue Contact First Name | Case Form/ General Information/ Reporter Information/ First Name |
| Product Issue Contact Last Name | Case Form/ General Information/ Reporter Information/ Last Name |
| Product Issue Contact Location Address | Case Form/ General Information/ Reporter Information/ Address |
| Product Issue Contact Location City | Case Form/ General Information/ Reporter Information/ City |
| Product Issue Contact Location State | Case Form/ General Information/ Reporter Information/ State/Province |
| Product Issue Contact Location Country | Case Form/ General Information/ Reporter Information/ Country |
| Product Issue Contact Location Zip Code | Case Form/ General Information/ Reporter Information/ Postal Code |
| SafetySystemStudyID entered for the Protocol | Case Form/General/Study Information/Study ID |
| Product Issues Patient Tab Patient ID | Case Form / Patient / Patient Information / Pat. ID |
| Product Issues Patient Tab Date of Birth | Case Form / Patient / Patient Information / Date of Birth |
| Product Issues Patient Tab Age | Case Form / Patient / Patient Information / Age, Case Form / Patient / Patient Information / Age Units |
| Product Issues Patient Tab Weight | Case Form / Patient / Patient Information / Weight |
| Product Issues More Info tab Reported Outcome of Event | Case Form / Events / Event Information / Outcome of Event |
| More Info tab Event severity | Case Form / Events / Event Information / Event Intensity |
| Product Issues More Info tab Tests/Data | Case Form / Patient / Lab Data / Lab Data / Notes |
| Drug Fields | |
| Product Issues Product Name | Case Form / Products / Product Information / Product Name |
| Product Issues Product Lot# | Case Form / Products / Dosage Regimens / Batch/Lot # |
| Product Frequency | Case Form / Products / Dosage Regimens / Frequency |
| Product Dose/Unit and UOM | Case Form / Products / Dosage Regimens / Dose Case Form / Products / Dosage Regimens / Daily Dosage |
| Product Route Used | Case Form / Products / Dosage Regimens / Patient Route of Administration |
| Product Indication | Case Form / Products / Product Indication / Coded Indication |
| Device Fields | |
| Product Issue Product Name | Case Form/Products/Device/Product Name |
| Product Issue Product Lot# | Case Form/Products/Device Information/Lot # |
| Product Issue Product Model# | Case Form/Products/Device Information/Model # |
| Product Issue Product Catalog# | Case Form/Products/Device Information/Catalog # |
| Product Issue Product Serial# | Case Form/Products/Device Information/Serial # |
| Product Issue Product Device Operator | Case Form/Products/Device Information/Operator of Device |
| Product Issue Product Mfg Date | Case Form/Products/Device Information/Date of Mfr |
| Product Issue Product Expiration Date | Case Form/Products/Device Information/Expiration Date |
| Product Issue Product Implant Date | Case Form/Products/Device Information/Date Implanted |
| Product Issue Product Explant Date | Case Form/Products/Device Information/Date Explanted |
| Product Issue Investigation Tab Evaluated by Mfg | Case Form/Products/Device MedWatch Info/ Device evaluated by mfr? |
| Product Issue Product Device Available | Case Form/Products/Device Information/Device Available for Evaluation |
| Yes if Product Issue Product Reprocessed is checked and Labeled Single Use is checked and Usage of Device = "Reuse" | Case Form/Products/Device MedWatch Info/ Is this a Single use device that was Reprocessed and Reused on a patient |
| Product Issue MDV Tab Usage of Device | Case Form/Products/Device MedWatch Info/Usage of Device |
| Product Issue Product Return Date | Case Form/Products/Device Information/Returned to Manufacturer on |
| Product Issue MDV Tab Mfg Narrative | Case Form/Products/Device MedWatch Info/Additional Manufacturer Narrative |
| Product Issue Investigation Tab Remedial Action Type | Case Form/Products/Device MedWatch Info/Remedial Action Taken |
| Product Issue Investigation Tab Remedial Action Other | Case Form/Products/Device MedWatch Info/Remedial Action Taken Other |
| Product Issue Product Reprocessor | Case Form/Products/Device MedWatch Info/Name and Address of Reprocessor |
| Product Issue Product Reprocessor Address | Case Form/Products/Device MedWatch Info/Name and Address of Reprocessor |
| Product Issue Product Reprocessor City | Case Form/Products/Device MedWatch Info/Name and Address of Reprocessor |
| Product Issue Product Reprocessor State | Case Form/Products/Device MedWatch Info/Name and Address of Reprocessor |
| Product Issue Product Reprocessor Country | Case Form/Products/Device MedWatch Info/Name and Address of Reprocessor |
| Product Issue Product Reprocessor Zip | Case Form/Products/Device MedWatch Info/Name and Address of Reprocessor |
| Product Issue Investigation Tab Evaluation Codes Method Codes | Case Form/Products/Device MedWatch Info/Evaluation Codes first row |
| Product Issue Investigation Tab Evaluation Codes Result Codes | Case Form/Products/Device MedWatch Info/Evaluation Codes second row |
| Product Issue Investigation Tab Evaluation Codes Conclusion Codes | Case Form/Products/Device MedWatch Info/Evaluation Codes third row |
| Patient when sending Patient, Device when sending Device | Case Form/Analysis/MedWatchInfo/FDA Codes/Patient or Device |
| Product Issues MDV Tab Patient Code or Device Code | Case Form/Analysis/MedWatchInfo/FDA Codes.
Note that this integration can only populate 3 Patient Codes and 3 Device Codes into Oracle Argus Safety |
The table below describes the configuration properties.
| Service Name | Property Name | Value | Description |
|---|---|---|---|
| ReportDrugSafetyReportSEBLReqABCSImpl | Default.SystemID | SEBLCLIN_01 | Default System ID is associated with this service. It is used for searching the DVMs, and XREFS when no other system IDs are found in the system registry. |
| ReportDrugSafetyReportSEBLReqABCSImpl | SendNonE2B | false (default), true | This field controls sending of Non E2B, non device fields from Siebel AECM to Oracle Argus Safety. This includes Reported to FDA and Event Severity fields. If it set to false, then Non E2B fields are not sent to Oracle Argus Safety. |
| ReportDrugSafetyReportSEBLReqABCSImpl | SendDeviceFields | false (default), true | This field controls sending of Device specific fields from Siebel AECM to Oracle Argus Safety. |
| ReportDrugSafetyReportSEBLReqABCSImpl | ABCSExtension.
PreXformABMtoEBM |
false (default), true. | Custom extension prior to the execution of transformation of application business message
(ABM) to Enterprise Business Message (EBM). |
| ReportDrugSafetyReportSEBLReqABCSImpl | ABCSExtension.
PreInvokeEBS |
false (default), true | Custom extension prior to the invocation of the enterprise business service (EBS). |
| ReportDrugSafetyReportSEBLReqABCSImpl | ABCSExtension.PostXformABMtoEBM | false(default),true | Custom extension just after execution of transformation of Application Business message (ABM) to Enterprise Business Message (EBM) and prior to the call to the Enterprise Business Service (EBS). |
| ReportDrugSafetyReportSEBLReqABCSImpl | Routing.HealthSciencesDrugSafetyReportEBS.ReportDrugSafetyReport.MessageProcessingInstruction.EnvironmentCode | PRODUCTION(default), CAVS | Setting the value to PRODUCTION indicates that the request must be sent to a concrete endpoint. Setting the value to CAVS indicates that the request must be sent to CAVS Simulator. |
| ReportDrugSafetyReportSEBLReqABCSImpl | ABCSExtension.PostInvokeEBS | false (default), true | Custom extension just after invocation of the Enterprise Business Service (EBS). |
| ReportDrugSafetyReportSEBLReqABCSImpl | Routing.
HealthSciencesDrugSafetyReportEBS. ReportDrugSafetyReport.RouteToCAVS |
false (default), true | To test the requester Application Business Connector Service (ABCS) or when the provider ABCS is not available, you would want the requester ABCS to call a simulator instead of actual Oracle AIA services. |
| ReportDrugSafetyReportSEBLReqABCSImpl | Routing.HealthSciences
DrugSafetyReportEBS.ReportDrugSafetyReport. CAVS.EndpointURI |
oramds:/apps/AIAMetaData/AIAComponents/InfrastructureServiceLibrary
/AIAValidationSystemServlet/asyncresponsesimulator |
End point URL for CAVS, when RouteToCAVS property is set to true |
| ReportDrugSafetyReportArgusProvABCSImpl | Routing.HealthSciences
DrugSafetyReportEBS.ReportDrugSafetyReport. MessageProcessingInstruction.EnvironmentCode |
PRODUCTION(default), CAVS | Setting the
value to PRODUCTION indicates that the request must be sent to a concrete endpoint. Setting the value to CAVS indicates that the request must be sent to CAVS Simulator. |
| ReportDrugSafetyReportArgusProvABCSImpl | Default.SystemID | ARGUS_01 | Default System ID associated with this service. It is used for populating the Target System ID when no routing rules match. The Target System ID is used for looking up DVMs and XREFs. |
| ReportDrugSafetyReportArgusProvABCSImpl | TruncateFields | warning(default), truncate, notruncation | This field is used for controlling truncation of certain fields that exceed maximum length accepted by Oracle Argus Safety. The options are described below:
|
| ReportDrugSafetyReportArgusProvABCSImpl | ABCSExtension.PreXformEBMtoABM | false(default), true | Customer extension just prior to the execution of the EBM to ABM transformation. |
| ReportDrugSafetyReportArgusProvABCSImpl | ABCSExtension.PostXFormEBMtoABM | false(default), true | Customer extension just after transforming the Enterprise Business Message to the Argus XML format. |
| ReportDrugSafetyReportArgusProvABCSImpl | Routing.ReportDrugSafetyReportWriteE2BFileAdapter.RouteToCAVS | false(default), true | To test the provider ABCS or when the provider application is not available, you
would want the provider ABCS to call a simulator instead of an actual provider application service. |
| ReportDrugSafetyReportArgusProvABCSImpl | Routing.ReportDrugSafetyReportWriteE2BFileAdapter.CAVS.EndpointURI | oramds:/apps/AIAMetaData/AIAComponents/InfrastructureServiceLibrary/AIAValidationSystemServlet/asyncresponsesimulator | End point URL for CAVS, when RouteToCAVS property is set to true. |
| ReportDrugSafetyReportArgusProvABCSImpl | ABCSExtension.PreInvokeABS | false(default), true | Customer extension just prior to the invocation of the file adapter service to write the XML file to the Oracle Argus Safety Interchange server. |
| ReportDrugSafetyReportArgusProvABCSImpl | ABCSExtension.PostInvokeABS | false(default), true | Customer extension just after invoking the File adapter service to write the XML file to the Oracle Argus Safety Interchange server. |
| ReportDrugSafetyReportResponseArgusReqABCSImpl | Default.SystemID | ARGUS_01 | Default System ID associated with this service. It is used for looking up DVMs, XREFS, when no other system IDs are found in the system registry. |
| ReportDrugSafetyReportResponseArgusReqABCSImpl | ABCSExtension.PreXformABMtoEBM | false(default), true | Custom extension prior to the execution of transformation of the Argus acknowledgement message to the ReportDrugSafetyResponse message |
| ReportDrugSafetyReportResponseArgusReqABCSImpl | ABCSExtension.PostXformABMtoEBM | false(default), true | Customer extension just prior to the invocation of Enterprise Business Service and after transforming the Argus acknowledgement message to the ReportDrugSafetyResponse message. |
| ReportDrugSafetyReportResponseArgusReqABCSImpl | Routing.ReportDrugSafetyReportResponseReadAckFileAdapter.RouteToCAVS | false(default), true | To test the requester Application Business Connector Service (ABCS) or when the provider ABCS is not available, you would want the requester ABCS to call a simulator instead of actual Oracle AIA services. |
| ReportDrugSafetyReportResponseArgusReqABCSImpl | Routing. ReportDrugSafetyReportResponseReadAckFileAdapter.CAVS.EndpointURI | oramds:/apps/AIAMetaData/AIAComponents/InfrastructureServiceLibrary/AIAValidationSystemServlet/asyncresponsesimulator | End point URL for CAVS, when RouteToCAVS property is set to true |
| ReportDrugSafetyReportResponseArgusReqABCSImpl | ABCSExtension.PreInvokeEBS | false (default), true | Custom extension prior to the invocation of the enterprise business service (EBS). |
| ReportDrugSafetyReportResponseArgusReqABCSImpl | ABCSExtension.PostInvokeEBS | false (default), true | Custom extension after the invocation of the enterprise business service (EBS). |
| ReportDrugSafetyReportResponseArgusReqABCSImpl | Routing.HealthSciencesDrugSafetyReportEBSResponse.ReportDrugSafetyReportResponse.MessageProcessingInstruction.EnvironmentCode | PRODUCTION(default), CAVS | Setting the value to PRODUCTION indicates that the request must be sent to a concrete endpoint. Setting the value to CAVS indicates that the request must be sent to CAVS Simulator. |
| ReportDrugSafetyReportResponseSEBLProvABCSImpl | Default.SystemID | SEBLCLIN_01 | Default System ID associated with this service. It is used to set the TargetSystemID in the EBM header when no routing rules match. The TargetSystemID is used for looking up DVMs and XREFs. |
| ReportDrugSafetyReportResponseSEBLProvABCSImpl | ABCSExtension.PreXformEBMtoABM | false (default), true | Customer extension just prior to the execution of the EBM to ABM transformation. |
| ReportDrugSafetyReportResponseSEBLProvABCSImpl | ABCSExtension. PostXformEBMtoABM | false (default), true | Customer extension just prior to the invocation of the Siebel Web services. |
| ReportDrugSafetyReportResponseSEBLProvABCSImpl | Routing.LS_spcMedical_spcProduct_spcIssue_spcCreate_spcInbox_spcItem_spcInbound.RouteToCAVS | false (default), true | To test the provider ABCS or when the provider application is not available, you
would want the provider ABCS to call a simulator instead of an actual provider application service. |
| ReportDrugSafetyReportResponseSEBLProvABCSImpl | Routing.LS_spcMedical_spcProduct_spcIssue_spcCreate_spcInbox_spcItem_spcInbound.CAVS.EndpointURI | oramds:/apps/AIAMetaData/AIAComponents/InfrastructureServiceLibrary/AIAValidationSystemServlet/syncresponsesimulator | End point URL for CAVS, when RouteToCAVS property is set to true |
| ReportDrugSafetyReportResponseSEBLProvABCSImpl | Routing.LS_spcMedical_spcProduct_spcIssue_spcCreate_spcInbox_spcItem_spcInbound.MessageProcessingInstruction.EnvironmentCode | PRODUCTION(default), CAVS | Setting the
value to PRODUCTION indicates that the request must be sent to a concrete endpoint. Setting the value to CAVS indicates that the request must be sent to CAVS Simulator. |
| ReportDrugSafetyReportResponseSEBLProvABCSImpl | ABCSExtension.PreInvokeABS | false (default), true | Customer extension just prior to the invocation of Siebel web services. |
| ReportDrugSafetyReportResponseSEBLProvABCSImpl | ABCSExtension. PostInvokeABS | false (default), true | Customer extension just after invoking the Siebel Web services and after invoking Application Service. |
| Properties specific to Siebel Session Pool Manager are described below: | |||
| AIASessionPoolManager | all_hosts | NOSERVER SEBLCLIN_01 | SPM can work with multiple application web server instances.
In this property, list the hosts for which SPM can create a session token pool. Separate the host names by spaces. Each host has its own pool. This property is not prefixed with a HostId value. |
| AIASessionPoolManager | all_hosts.ProxySettings_Enabled | False | To enable SPM use proxy settings while calling the application web server, set this property to TRUE.
Set this property to FALSE to not use proxy settings. |
| AIASessionPoolManager | all_hosts.Proxy.Host | Specified by values populated in the Configuration Wizard. | It determines the server to be set in the system properties for http.proxyHost property.
In the java.net API used by SPM, proxies are supported through two system properties: http.proxyHost and http.proxyPort. They must be set to the proxy server and port respectively. This value is only set when ProxySettings_Enabled is set to TRUE. |
| AIASessionPoolManager | all_hosts.Proxy.Port | Specified by values populated in the Configuration Wizard. | It determines the port to be set in the system properties for the http.proxyPort property.
In the java.net API used by SPM, proxies are supported through two system properties: http.proxyHost and http.proxyPort. They must be set to the proxy server and port respectively. This value is only set when ProxySettings_Enabled is set to TRUE. |
| AIASessionPoolManager | SEBLCLIN_01.EndpointURI | Populated by values specified in the Configuration Wizard. (For example, <InternetProtocol>://<hostname>:<port>/eai_<language>/start.swe?SWEEXTSource=SecureWebService&SWEExtCmd=Execute&WSSOAP=1 | It determines the endpoint URI that Session Pool Manager uses to connect to the application web server. |
| AIASessionPoolManager | SEBLCLIN_01.UserId | Populated by values specified in the PIP Configuration Wizard. | It determines the user ID that is used to connect to the application web server. |
| AIASessionPoolManager | SEBLCLIN_01.Password | Populated by values specified in the PIP Configuration Wizard. | It determines the password that is used to connect to the application web server. This value is stored in the KEY store and is encrypted. |
| AIASessionPoolManager | SEBLCLIN_01.PredictExpiration_Idle | 780000 | Indicates the maximum time in milliseconds that a session token can be idle before expiring. We recommend that you set this value to a value lower than the actual maximum idle time configured for the application web server. We recommend a value lower than the actual value to compensate for the gap between the time at which the application web server responded and the time at which the BPEL flow called SPM to release the session token. |
| AIASessionPoolManager | SEBLCLIN_01.PredictExpiration_Age | 82800000 | Indicates the maximum age in milliseconds that a session token can reach before expiring. We recommend that you set this value to a value lower than the actual maximum age configured for the application web server. The creation time registered in the application web server is some seconds earlier than the one registered in SPM. A value of 1 or 2 minutes is a good start. For example, if the maximum age configured on the application web server is 15 minutes, set this property to 13 minutes. |
| AIASessionPoolManager | SEBLCLIN_01.InvalidSessionErrorCodes | 10944642|SBL-BPR-00162|SBL-DAT-00175|11338608|SBL-UIF-00880 | It determines the list of error codes that the application web server can return for a fault when the session token is not valid. |
| AIASessionPoolManager | SEBLCLIN_01.ClassName | oracle.apps.aia.core.sessionpool.CRMSiebelSession | It determines the full class name that SPM uses to get the session tokens from the application server. The class listed in this property implements the oracle.apps.aia.core.sessionpool.PoolableResource interface. |
At times, applications are moved to new servers or databases for various reasons. This section describes how to update the information that was provided during Install time when the integration is already installed and deployed.
To modify information about Siebel AECM, follow these steps:
The information about the Siebel AECM Host name and Port given during install is used to define the EndPointURI to call the Siebel Web services. If you have moved Siebel AECM to a new server, you must update the SEBCLIN_01.EndPointURI property in the AIAConfigurationProperties.xml file.
Navigate to $AIA_INSTANCE/AIAMetaData/config directory and open the file AIAConfigurationProperties.xml. Search for SEBLCLIN_01.EndpointURI and replace the Host name and Port, if they have changed.
Upload updated AIAConfigurationProperties.xml file to MDS. Follow these steps to upload the file to MDS:
Update the fileset element in the $AIA_INSTANCE/config/UpdateMetaDataDP.xml file to point to the location of the AIAConfigurationProperties.xml file as shown below:
<fileset dir=$AIA_INSTANCE/AIAMetaData/">
<include name=" config/AIAConfigurationProperties.xml" />
</fileset>
Upload to MDS using the command given below. Wait till you see a build successful result.
source $AIA_INSTANCE/bin/aiaenv.sh
ant -f <AIA_HOME>/Infrastructure/Install/config/UpdateMetaData.xml
If you have changed the user name and password for the Siebel EAI user that you had specified during installation, follow the steps given below. To help you change passwords, AIA provides a utility called UpdateStore. AIA stores its passwords in Keystore. UpdateStore utility aids you in modifying the existing passwords in the Keystore.
Steps:
Source the aiaenv.sh in the $AIA_INSTANCE/bin.
Navigate to $AIA_HOME/util/
Execute ant -f updateStore.xml updateStore -DAdminUsername=<weblogic adminusername> -DAdminPassword=<weblogic admin password>
Update AIA Keystore screen appears.
Enter the Existing Username, Existing Password, New Username, and New Password and the Xpath of the password that you want to change.
The Xpath is /properties/participatingapplications/sc/server/eai/password
If the Siebel Enterprise Server name is different, you must log into the AIA Application and navigate to the System Registry. You must change the value of Internal ID for the row with System ID = SEBCLIN_01 to the name of the new Siebel Enterprise Server.
To configure a different Oracle Argus Safety Interchange server, follow these steps:
Note: This scenario assumes that there is an existing mount point between integration pack SOA_server and Oracle Argus Safety Interchange server. The mount point is reconfigured to point to the new Oracle Argus Safety Interchange server.
On integration pack SOA_server, change the file mount on SOA_server to point to the new Oracle Argus Safety Interchange (ESM) server.
To configure a different folder for Oracle Argus Safety Interchange server, follow these steps:
Note: This scenario assumes that there is an existing folder on integration pack SOA_server that is mounted on to Oracle Argus Safety Interchange server. You may choose the integration pack to use a different folder on integration pack SOA_server to mount with Oracle Argus Safety Interchange server.
Update $AIA_INSTANCE/config/AIAInstallProperties.xml using the following steps:
To change the E2B files input directory: Search for element <xmldir> and replace the value contained within the <xmldir> node with the new value.
To change the Acknowledgement files output directory: Search for element <ackdir> and replace the value contained within the <ackdir> node with the new value.
Note that <xmldir> and <ackdir> nodes are present within the node structure of <properties>, then <participatingapplications>, then <argus>, then <server>, and then <case>.
For more information about configuring Oracle Argus Safety, see Oracle® Device and Drug Adverse Event Data Integration Pack for Siebel Adverse Event Complaint Management and Oracle Argus Safety Installation Guide, "Performing Post-Installation Configurations".
You need to upload the modified AIAInstallProperties.xml file to the MDS before the deployment.
Navigate to $AIA_INSTANCE/config
Copy UpdateMetaDataDp.xml to a backup file.
Edit the file as follows:
<?xml version="1.0" standalone="yes"?>
<DeploymentPlan component="Metadata" version="3.0">
<Configurations>
<UpdateMetadata wlserver="fp" >
! <fileset dir="${AIA_HOME}/AIAMetaData">
<include name="config/AIAInstallProperties.xml" />
</fileset>
</UpdateMetadata>
</Configurations>
</DeploymentPlan>
Navigate to $AIA_ INSTANCE/bin
source aiaenv.sh
ant -f $AIA_HOME/Infrastructure/Install/config/UpdateMetaData.xml
Wait to see the BUILD SUCCESSFUL message.
Create a custom deployment plan to deploy:
ReportDrugSafetyReportReadAckFileAdapter
ReportDrugSafetyReportWriteE2BFileAdapter composites
Open the file $AIA_HOME/pips/DrugDeviceAESEBLandArgus/DeploymentPlans/DrugDeviceAESEBLandArgusCustomDP.xml
Replace <Deployments> </Deployments> with the following:
<Deployments>
<Composite compositeName="ReportDrugSafetyReportWriteE2BFileAdapter "
compositedir="$AIA_HOME/services/core/ArgusSafety/AdapterServices/ReportDrugSafetyReportWriteE2BFileAdapter " revision="1.0" wlserver="pips.DrugDeviceAESEBLandArgus" action="deploy" overwrite="true"/>
<Composite compositeName="ReportDrugSafetyReportReadAckFileAdapter "
Compositedir="$AIA_HOME/services/core/ArgusSafety/AdapterServices /ReportDrugSafetyReportReadAckFileAdapter " revision="1.0" wlserver="pips.DrugDeviceAESEBLandArgus" action="deploy" overwrite="true"/>
</Deployments>
Save DrugDeviceAESEBLandArgusCustomDP.xml
Run customDP by executing the following command:
Set the environment variables by executing "source <AIA_HOME>/aia_instances/AIA11115/bin/aiaenv.sh"
Run the custom deployment command for deploying the customized artifacts:
ant -f $AIA_HOME/Infrastructure/Install/AID/AIAInstallDriver.xml -DDeploymentPlan=$AIA_HOME/pips/DrugDeviceAESEBLandArgus/DeploymentPlans/DrugDeviceAESEBLandArgusCustomDP.xml -DPropertiesFile=$AIA_INSTANCE/config/AIAInstallProperties.xml -l <location and name of the log file>
Cross-references map and connect the records within the application network, and enable these applications to communicate in the same language. The integration server stores the relationship in a persistent way so that others can refer to it.
For more information about cross-references, see Oracle Fusion Middleware Developer's Guide for Oracle SOA Suite, "Working with Cross References".
This is the cross-reference for Device and Drug Adverse Event: Siebel AECM and Argus Safety PIP:
| XREFTABLENAME | COLUMN NAME | DESCR | USAGE |
|---|---|---|---|
| DRUGSAFETYREPORT_CASEID | COMMON | System generated GUID to uniquely identify the case. | This column is populated when a row is created in the table when a new Product Issue is sent to Oracle Argus Safety. |
| DRUGSAFETYREPORT_CASEID | SEBL_01 | Product Issue ID | This column is populated when a row is created in the table when a new Product Issue is sent to Oracle Argus Safety |
| DRUGSAFETYREPORT_CASEID | ARGUS_01 | The current Argus Case ID that the Product Issue is associated with. | This column is populated with the Case ID in Oracle Argus Safety that a new case/follow-up is accepted into.
If a follow-up is accepted into a different case than the original product issue was accepted into, this field is updated with the new Case ID. |
Domain value maps (DVMs) are a standard feature of the Oracle SOA Suite and enable you to equate lookup codes and other static values across applications. For example, "FOOT" and "FT" or "US" and "USA."
DVMs are static in nature, though administrators can add and update additional maps as needed. Transactional business processes never update DVMs-they only read from them.
Most of the DVMs below are pre-populated with the default values that ship with Siebel AECM and the default values that are expected by Oracle Argus Safety when importing an E2B+ file.
For fields which are part of the E2B standard, Oracle Argus Safety expects the values required by E2B when importing the case into Oracle Argus Safety. This PIP pre-populates the DVMs with these codes for you.
For more information about Language Independent Codes (LIC), see Configuring Siebel Business Applications, Version 8.1, Rev. B,"Localizing Siebel Business Applications - Localizing a Multilingual List of Values".
For more information on the codes, see Electronic Transmission of Individual Case Safety Reports Message Specification v2.3.
These are the DVMs for Device and Drug Adverse Event: Siebel AECM and Argus Safety PIP:
| DVM Name | DVM Column Name | Comments |
|---|---|---|
| DRUGSAFETYREPORT_REPORTTYPE | SEBLCLIN_01, COMMON, ARGUS_01 | This maps the Report Type display value in Siebel AECM to the E2B code expected by Oracle Argus Safety. |
| DRUGSAFETYREPORT_QUALIFICATIONCODE | SEBLCLIN_01, COMMON, ARGUS_01 | This maps the language independent code (LIC) defined in Siebel tools for the Qualification code value to the E2B code expected by Oracle Argus Safety for Reporter type. |
| GENDER | SEBLCLIN_01, COMMON, ARGUS_01 | This maps the display values for gender in Siebel AECM to the E2B codes expected by Oracle Argus Safety. |
| DRUGSAFETYREPORT_ADVERSEEVENTREPORTEDOUTCOME | SEBLCLIN_01, COMMON, ARGUS_01 | This maps the Reported Outcome for the adverse event in Siebel AECM to the Reported Outcome for the adverse event in Oracle Argus Safety. |
| DRUGSAFETYREPORT_ADVERSEEVENTSEVERITY | SEBCLIN_01, COMMON, ARGUS_01 | This maps the adverse event severity in Siebel AECM to the Adverse Event intensity in Oracle Argus Safety. |
| DRUGSAFETYREPORT_DRUGADMINISTRATIONROUTE | SEBLCLIN_01, COMMON, ARGUS_01 | This maps the Route Used for a Product in Siebel AECM to the Patient Route of Administration in Oracle Argus Safety. |
| DRUGSAFETYREPORT_DEVICEOPERATOR | SEBCLIN_01, COMMON, ARGUS_01 | This maps the Device Operator in Siebel AECM to the Operator of Device in Oracle Argus Safety. |
| DRUGSAFETYREPORT_DEVICEUSE | SEBLCLIN_01, COMMON, ARGUS_01 | This maps Usage of Device for the Product Issue in Siebel AECM to Usage of Device in Oracle Argus Safety. |
| DRUGSAFETYREPORT_DEVICEREREMEDIALACTION | SEBLCLIN_01, COMMON, ARGUS_01 | This maps the Remedial Action Type in Siebel AECM to the Remedial Action Taken in Oracle Argus Safety.
Note: Do not change the ARGUS_01 values in this DVM. The display in Oracle Argus Safety is dependent upon the values we ship with for this DVM. |
| DRUGSAFETYREPORT_STATUS | SEBLCLIN_01, COMMON, ARGUS_01 | This maps the acceptance/rejection of the case in Oracle Argus Safety to the Product Issue status in Siebel AECM. |
| STATE DVM | SEBLCLIN_01, COMMON, ARGUS_01 | This maps the state in Siebel AECM to the state part of an address in Oracle Argus Safety. By default the 50 states in the U.S. are populated for Siebel AECM and COMMON. There are no values pre-populated for ARGUS_01. Oracle Argus Safety does not validate the state against a codelist so there is no need to modify this list.
However, if the list is not populated the value specified in the COMMON column is used in the addresses in Oracle Argus Safety. |
| COUNTRY DVM | SEBLCLIN_01, COMMON, ARGUS_01 | This maps the country of the Product Issue contact to the country of the reporter in Oracle Argus Safety. This also maps the Country Of Incidence in Siebel AECM to the Country of Incidence in Oracle Argus Safety. It also maps the country specified in an address in Siebel AECM that is sent to an address in Oracle Argus Safety. |
| UNIT OF MEASURE DVM | SEBLCLIN_01, COMMON, ARGUS_01 | This maps the Unit of Measure used in Siebel AECM for the product Dose/Unit to the unit of measure in Oracle Argus Safety for the Product Dosage. |
For more information about working with DVMs, see Oracle Fusion Middleware Developer's Guide for Oracle SOA Suite 11g Release 1, "Working with Domain Value Maps" and "Using Oracle SOA Composer with Domain Value Maps".
Error Messages are described in the table below:
| Error Condition | Message Name | Message Text |
|---|---|---|
| Requester ABCS throws an exception when downstream services are not available | ORAMED-03302:[Exception in one way execution] | Unexpected exception in one-way operation "ReportDrugSafetyReport" on reference "ReportDrugSafetyReportSEBLReqABCSImpl".Possible
Check whether the reference service is properly configured and running or look at exception for analyzing the reason or contact Oracle Support Services. Refer to the section Using the Message Resubmission Utility for the steps to resubmit failed messages. |
| DVM values not found | DVMValueNotFound | "The value entered for the REPORTTYPE does not exist in <SEBLCLIN_01> column for the DRUGSAFETYREPORT_REPORTTYPE DVM. Please add the value to the DRUGSAFETYREPORT_REPORTTYPE DVM." |
| DVM values not found | DVMValueNotFound | When E2B field reporttype DVM look up fails because report type data does not match DVM value, the following text is used:
"The value entered for the REPORTTYPE does not exist in <ARGUS_01> column for the DRUGSAFETYREPORT_REPORTTYPE DVM. Please add the value to the DRUGSAFETYREPORT_REPORTTYPE DVM." |
| TruncateFields is set to 'warning' and one or more fields have exceeded maximum length. | ArgusProviderTruncateFieldsWarning | The following fields were truncated due to exceeding the length required by Oracle Argus Safety:
<DTD field name 1> : <length required by Argus> … <DTD field name N> : <length required by Argus> |
| Siebel inbound web services are down. In such case, AIA Session Pool Manager is set to retry 3 times to connect to the Siebel Server with 500 milli seconds between each retry attempt. | 404 | Page Not Found. |
| Response SEBL Provider ABCS fails to call Siebel Web Services. | ORAMED-03302:[Exception in oneway execution] | Unexpected exception in one-way operation "ReportDrugSafetyReportResponse" on reference "ReportDrugSafetyReportResponseSEBLProvABCSImpl ".Possible
Check whether the reference service is properly configured and running or look at exception for analyzing the reason or contact Oracle Support Services. Please Refer to the section Using the Message Resubmission Utility for the steps to resubmit failed messages. |
For more information about AIA error handling, see the Oracle Application Integration Architecture - Foundation Pack: Core Infrastructure Components Guide, "Setting Up and Using Error Handling and Logging."
This section describes the steps for using the Resubmission utility when the flows fail. For example, if a flow fails because of a system fault like a server being down for maintenance, you can resubmit the flow when the server is up.
AIA provides Message Resubmission Utility to re-submit failed messages for the flow from Siebel AECM to Argus Safety. The following steps give an overview of resubmitting messages to the JMS queue.
To use the Message Resubmission Utility:
Set the following values in the ResubmissionParams.properties file located in $AIA_HOME/util/AIAMessageResubmissionUtil:
jms.app.userName=<weblogic administrator user> (For example, weblogic):
jms.app.password=< Weblogic administrator password>
jms.moduleName=SEBLJDBCJMSModule
jms.resourceCFJndi= jms/aia/AIA_SEBLDrugSafetyReportJMSQueueCF
jms.errorResourceCFJndi= AIA_SEBLDrugSafetyReportJMSQueueCF
resourceType=1
resourceName= AIA_SEBLDrugSafetyReportJMSQueue
messageID= Click the link in the email notification of the fault to get the value of message ID. The flow that is faulted is indicated in the Enterprise Manager. Use the value of <corecom:SenderMessageID> from the EBM header as the message ID.
For Windows: execute $AIA_INSTANCE\bin\aiaenv.bat.
For Linux: source $AIA_INSTANCE/bin/aiaenv.sh.
Navigate to $AIA_HOME/util/AIAMessageResubmissionUtil and execute the following ant command:
ant -f MessageResubmit.xml -l $AIA_HOME/util/AIAMessageResubmissionUtil/MessageResubmit.log
The MessageResubmit.xml script references the edited ResubmissionParams.properties file. Once run, the script resets the message status back to a ready state so that the transaction can resume its flow.
Using the Resubmission Utility for the Failure of Flow from Oracle Argus Safety to Siebel AECM
Follow these steps for using the resubmission utility when the flow from Oracle Argus Safety to Siebel AECM fails:
Set the following values in the ResubmissionParams.properties file located in $AIA_HOME/util/AIAMessageResubmissionUtil:
jms.app.userName=<weblogic administrator user> (e.g. weblogic)
jms.app.password=<weblogic administrator password>
jms.moduleName=SEBLJDBCJMSModule
jms.resourceCFJndi= jms/aia/AIA_SEBLDrugSafetyReportJMSQueueCF
jms.errorResourceCFJndi= AIA_SEBLDrugSafetyReportJMSQueueCF
resourceType=3
resourceName= default/ReportDrugSafetyReportReadAckFileAdapter!1.0
messageID= Get the value of messageID by navigating to the Enterprise Manager from the link in the email notification. Click the Recovery link in the faults section. Enter the group ID shown as the value of messageID.
For Windows: execute $AIA_INSTANCE\bin\aiaenv.bat
For Linux: source $AIA_INSTANCE/bin/aiaenv.sh
Navigate to $AIA_HOME/util/AIAMessageResubmissionUtil and execute the following ant command:
ant-f MessageResubmit.xml -l $AIA_HOME/util/AIAMessageResubmissionUtil/MessageResubmit.log
The MessageResubmit.xml script references the edited ResubmissionParams.properties file. Once run, the script resets the message status back to a ready state so that the transaction can resume its flow.
This integration can be extended to send the fields that you have added to Siebel AECM or Oracle Argus Safety.
This section describes an example of how the extended fields can be sent across. In this example, assume that:
Patient Extension field is added Product Issues screen in Siebel AECM
Patient Extension field is added Patient tab in Oracle Argus Safety
Patient Extension field is added with the name PatientExtension to the Integration Object using Siebel Tools after the field AETypeCalc
Overview of the Steps:
Add new Element to Siebel AECM xsd. Upload to MDS
Add new Element to Custom EBO xsd. Upload to MDS
Verify Custom EBO is uploaded to MDS
Add new Element to Oracle Argus Safety xsd. Upload to MDS
Add custom transformations to custom xsl in ReportDrugSafetyReportSEBLRequesterABCS composite
Add custom transformations to custom xsl in ReportDrugSafetyReportArgusProviderABCS composite
Create a custom deployment plan to deploy composites on SOA server
Modify Argus DTD, and run SQL to add new field to Oracle Argus Safety
Test Extension field.
To map the newly added custom field in Siebel AECM payload to the corresponding newly added custom field in Oracle Argus Safety follow these steps:
Add New Element to Siebel xsd:
It is advisable that you back up the .xsd file first, before adding a new element to it. Start Jdeveloper and open file <AIA_HOME>/AIAMetaData/AIAComponents/ApplicationObjectLibrary/SiebelAECM/V1/schemas/ListOfLSMedicalToSafetyIntegProductIssueInterfaceTarget.xsd
As per the example used in this section, PatientExtension element is mapped in the Siebel AECM. This element is available at the location:
LsMedicalProductIssue > PatientExtension below the AETypeCalc element
Expand the element LsMedicalProduct Issue and locate the AETypeCalc element.
Right click AETypeCalc element and select Insert after element - AETypeCalc> element.
Name this element as PatientExtension of type xsd:string as shown below and save the changes.
Upload the modified xsd to MDS using these steps:
Place the modified xsd on SOA server in the following location: <AIA_HOME>/AIAComponents/ApplicationObjectLibrary/SiebelAECM/V1/schemas
Update the fileset element in the UpdateMeataDataDP.xml file (at $AIA_INSTANCE/config) to point to the location of the xsd file as shown below:
<fileset dir="${AIA_HOME}/AIAMetaData">
<include name="AIAComponents/ApplicationObjectLibrary/SiebelAECM/V1/schemas/ListOfLSMedicalToSafetyIntegProductIssueInterfaceTarget.xsd" />
</fileset>
Upload to MDS using the command below. Wait till you see a build successful result.
source /slot/ems3390/oracle/AIA11115/aia_instances/AIA11115/bin/aiaenv.sh
ant-f/slot/ems3390/oracle/AIA11115/Infrastructure/Install/config/UpdateMetaData.xml
Add a New Element to the EBO:
In the current example since we are adding Patient Extension field we shall extend the component DrugSafetyReportPatient in the EBO to include this field.
It is advisable that you back up the .xsd file first, before adding a new element to the EBO. Start JDeveloper and open the file: <AIA_HOME>/AIAMetaData/AIAComponents/EnterpriseObjectLibrary/Industry/HealthSciences/Custom/EBO/DrugSafetyReport/V1/CustomDrugSafetyReportEBO.xsd
There are several types defined in the xsd, as shown below:
Each type name is a place holder for the Custom field it extends. For example, the custom field place holders for DrugSafetyReportPatient is CustomDrugSafetyReportPatientType.
Right click CustomDrugSafetyReportPatientType, and select Insert inside complexType > Sequence
Right click the new sequence and select Insert inside Sequence > element to add a new element to the sequence. Name the element as PatientExtension. The new element should appear as shown below:
Set Datatype for the new element that is added. Right click the element and select Set Type. From the drop-down list select corecom:StringType. Save the xsd file.
Upload the custom file to MDS using these steps:
Place the xsd file in the following directory: <AIA_HOME>/AIAComponents/EnterpriseObjectLibrary/Industry/HealthSciences/Custom/EBO/DrugSafetyReport/V1/
Update the $AIA_INSTANCE/config/UpdateMetaDataDP.xml to have following fileset entry:
<fileset dir="${AIA_HOME}/AIAMetaData">
<include name="AIAComponents/EnterpriseObjectLibrary/Industry/HealthSciences/Custom/EBO/DrugSafetyReport/V1/CustomDrugSafetyReportEBO.xsd" />
</fileset>
Upload to MDS using the command given below. Wait till you see a build successful result.
source
$AIA_INSTANCE/bin/aiaenv.sh
ant-f <AIA_HOME>/Infrastructure/Install/config/UpdateMetaData.xml
Verify Custom EBO xsd Upload to MDS:
(Assumes that JDeveloper Resource Palette is configured to browse SOA_MDS database for a given database.)
In JDeveloper, open the Resource Palette and navigate to the files mentioned above at the specified locations.
Double click the files to open, and verify the changes made.
Also verify the AIAMetaData\AIAComponents\EnterpriseObjectLibrary\Industry\HealthSciences\EBO\DrugSafetyReport\V1\DrugSafetyReportEBO.xsd to check whether the changes made to the CustomDrugSafetyReportEBO.xsd are reflected. Locate the DrugSafetyReportPatient element in the xsd.
Expand the element and navigate to the end to locate the Custom element.
Modify Argus xsd:
It is advisable that you back up the .xsd file first, before modifying it.
In Jdeveloper open file <AIA_HOME>/ AIAComponents/ApplicationObjectLibrary/ArgusSafety/V1/schemas/ich-icsr-v2.1_integration.xsd
Locate the element under which the new field should appear. In this example, the field should be present under the location: ichicsr > safetyreport > patient.
Always add the custom element at the end of the sequence of children elements.
Add the reference properties of newly created reference in the same xsd. For example, for patientextn_extension, add the following to the same xsd:
Save the changes to the xsd.
Upload the xsd to MDS using these steps:
Copy the XSD to a directory structure similar to that of MDS.
Update the $AIA_INSTANCE/config/UpdateMetaDataDP.xml to have following fileset entry:
<fileset dir="${AIA_HOME}/AIAMetaData">
<include name="AIAComponents/ApplicationObjectLibrary/ArgusSafety/V1/schemas/ich-icsr-v2.1_integration.xsd" />
</fileset>
Upload to MDS using the command given below. Wait till you see a build successful result.
source $AIA_INSTANCE/bin/aiaenv.sh
ant-f <AIA_HOME>/Infrastructure/Install/config/UpdateMetaData.xml
Add Transformation to ReportDrugSafetyReportSEBLReqABCSImpl
Assumes that JDeveloper is set up with the following configurations:
Resource Palette is configured to browse SOA_MDS database for a given database.
JavaWS application is configured to which the .jpr files can be added.
Get the following ReportDrugSafetyReportSEBLReqABCSImpl and ReportDrugSafetyReportArgusProvABCSImpl from application server to local JDeveloper environment.
This may involve copying corresponding composite projects from the application server's folders <AIA_HOME>/services/core/SiebelAECM/RequesterABCS and $AIA_HOME/services/ core/ArgusSafety/ProviderABCS to the local JDeveloper environment.
It is advisable that you back up the .xsl file first, before the mapping activity.
In JDeveloper, click Open, navigate to ReportDrugSafetyReportSEBLReqABCSImpl.jpr
Expand the project and, under the xsl folder, open Xform_DrugSafetyReportABMReqMsg_to_DrugSafetyReportEBMReqMsg_Custom.xsl
In the JDeveloper design view, map the newly added custom field PatientExtension in Siebel ABM and PatientExtension in ReportDrugSafetyReportEBM
Navigate to the Source tab. Note that a template contains the mapping that you created above under "<xsl:template match="/">" element.
There are multiple templates provided in the custom xsl. For example, there is ReportDrugSafetyReportDrugType_ext for extending DrugSafetyReportDrug component of the ebo, ReportDrugSafetyReportMedicalDeviceType_ext for extending DrugSafetyReportDevice component of the ebo. Cut the content enclosed in <ebo:custom> tag and paste the same in the appropriate template. For the current example, ReportDrugSafetyReportPatientType_ext template should be used.
Remove the content enclosing <xsl:template match="/"> tag, which was auto-generated by the designer. Save your changes to custom xsl.
Note: The xsl may also be modified using other text editors. Please ensure that namespaces (For example: ebo, ns0 are appropriately assigned in such cases).
Add Transformation to ReportDrugSafetyReportArgusProvABCSImpl
Assumes that JDeveloper is set up with the following configurations:
Resource Palette is configured to browse SOA_MDS database for a given database
JavaWS application is configured to which .jpr files can be added.
It is advisable that you back up the .xsl file first. In JDeveloper, click Open, navigate to Xform_DrugSafetyReportReqMsg_to_DrugSafetyReportRespMsg_Custom.xsl
In the JDeveloper design view, map the custom field PatientExtension in ReportDrugSafetyReportEBM to patientextn_extension in Argus ABM.
Navigate to Source view. Note that there are multiple templates provided in the custom xsl. Design view adds the mapping created in step b above in a default template <xsl:template match="/">. Modify the default template by cutting the content enclosed by "_extension" element and pasting it in the correct template. For example, <patientextn_extension> should be moved to patientType_ext template as shown below.
Remove the content surrounding <xsl:template match="/">, which was auto-generated by the designer. Save your changes to the custom xsl.
Deploy the Composites:
On the application server, ensure that ReportDrugSafetyReportSEBLReqABCSImpl and ReportDrugSafetyReportArgusProvABCSImpl are updated with customizations.
(This involves copying the modified custom xsls to the application server's folders $AIA_HOME/services/core/SiebelAECM/RequesterABCS/ ReportDrugSafetyReportSEBLReqABCSImpl/xsl and $AIA_HOME/services/core/ArgusSafety/ProviderABCS/ ReportDrugSafetyReportArgusProvABCSImpl /xsl correspondingly).
Open the file $AIA_HOME/pips/DrugDeviceAESEBLandArgus/DeploymentPlans/DrugDeviceAESEBLandArgusCustomDP.xml
Replace <Deployments> </Deployments> with the following:
<Deployments>
<Composite compositeName="ReportDrugSafetyReportArgusProvABCSImpl"
compositedir="${AIA_HOME}/services/core/ArgusSafety/ProviderABCS/ReportDrugSafetyReportArgusProvABCSImpl" revision="1.0" wlserver="pips.DrugDeviceAESEBLandArgus" action="deploy" overwrite="true"/>
<Composite compositeName="ReportDrugSafetyReportSEBLReqABCSImpl" compositedir="${AIA_HOME}/services/core/SiebelAECM/RequesterABCS/ReportDrugSafetyReportSEBLReqABCSImpl" revision="1.0" wlserver="pips.DrugDeviceAESEBLandArgus" action="deploy" overwrite="true"/>
</Deployments>
Save the file.
Set the environment variables by executing "source <AIA_HOME>/aia_instances/<AIA_INSTANCE_NAME>/bin/aiaenv.sh"
Run the custom deployment command for deploying customized artifacts
ant-f $AIA_HOME/Infrastructure/Install/AID/AIAInstallDriver.xml -DDeploymentPlan=$AIA_HOME/pips/DrugDeviceAESEBLandArgus/DeploymentPlans/DrugDeviceAESEBLandArgusCustomDP.xml -DPropertiesFile=$AIA_INSTANCE/config/AIAInstallProperties.xml -l <location and name where you want the log file written>
Create Custom Field in Oracle Argus Safety:
Modify the DTD file. On Oracle Argus Safety Interchange server, open the <ORACLE_HOME>/Argus/ESMService/DTDFiles/ ich-icsr-v2.1-FDA-PIP.DTD.
Add an extension field called patientextn_extension under patient as shown below:
In the same DTD file, add more details on this extension:
Save DTD file and exit. Ensure that you always add the extension elements to end of the sequence of children elements. For example, patientextn_extension is added after occupation_extension. This change in the DTD is equivalent to the change in the xsd in Step 4.b: Modifying Argus xsd.
Add field export and import logic. CFG_E2B table needs to have a row for each DTD_ELEMENT that is imported. The following SQLs are provided as an example for importing patientextn_extension. The values in the SQLs need to be modified depending on type of the field that is being added.
Login to SQL script execution tool such as SQL Developer or SQL Plus using ESM schema owner credentials for your Argus Safety database.
Execute the following SQLs:
insert into cfg_e2b (PROFILE, DTD_ELEMENT, HIE_LEVEL, DTD_TYPE, DELETED, DTD_LENGTH, LANGUAGE,MANDATORY_DTD_ELEMENT, MANDATORY, ORDER_OF_EXECUTION, AE_SELECT_STMT_ELEMENT_ASSOC, AE_SELECT_STMT_COL_POSITION, PARENT_ELEMENT, DATA_ELEMENT, AE_CASE_FORM_GUI, DTD_ELEMENT_TITLE, REPEATABLE, ALLOW_USER_PROC, AE_SELECT_STMT, AE_USER_PROC, DTD_ELEMENT_TYPE, UPDATE_FOR_NULLIFICATION, CHILD_ONLY_SQL, ALWAYS_IMPORT, DTD_ELEMENT_TITLE_J, ALLOW_JAPANESE_CHARACTERS, FIELD_LOCATION, FIELD_LABEL)
values ('ICH-ICSR V2.1 MESSAGE TEMPLATE - FDA PIP', 'PATIENTEXTN_EXTENSION', 7, 'DEFINED', null, 40, 'en', '', '', 121.4, 'PATIENT', 20, 'PATIENT', '', 'Case Form / Patient / Patient Information / patientextn', 'The patientextn of the patient', -1, null, null, null, 1, null, null, 0, '', null, '', '');
Update CFG_E2B
Set AE_USER_PROC =
'DECLARE'|| CHR(10) ||
' v_xml varchar2(32767);'|| CHR(10) ||
' l_return number := 0;'|| CHR(10) ||
' v_error_message varchar2(4000);'|| CHR(10) ||
' l_value varchar2(25);'|| CHR(10) ||
' v_prod_name varchar2(32767);'|| CHR(10) ||
' lb_return boolean := FALSE;'|| CHR(10) ||
' v_dtd_elements esm_imp.vtab; '|| CHR(10) ||
'BEGIN'|| CHR(10) ||
' v_xml := trim(ESM_IMP.F_READ_EXTENSION(:REPORT_ID,:DTD_ELEMENT));'|| CHR(10) ||
' if v_xml is not null then'|| CHR(10) ||
' v_dtd_elements(1) := ''DRUGCHARACTERIZATION'';'|| CHR(10) ||
' v_dtd_elements(2) := ''MEDICINALPRODUCT'';'|| CHR(10) ||
' v_dtd_elements(3) := ''DRUGDOSAGEFORM'';'|| CHR(10) ||
' v_prod_name := ESM_IMP.F_READ(:REPORT_ID,''MEDICINALPRODUCT'');'|| CHR(10) ||
' if v_prod_name is null then'|| CHR(10) ||
' v_dtd_elements(2) := ''ACTIVESUBSTANCENAME'';'|| CHR(10) ||
' end if;'|| CHR(10) ||
' lb_return := ESM_IMP.F_CHECK_AND_BUILD_KEY(:REPORT_ID,:PARENT_ELEMENT,v_dtd_elements); '|| CHR(10) ||
' l_value := v_xml;'|| CHR(10) ||
' l_return := ESM_IMP.F_WRITE(:REPORT_ID,:PARENT_ELEMENT,:DTD_ELEMENT,:PROFILE,''CASE_PAT_INFO'',''UD_TEXT_1'',l_value);'|| CHR(10) ||
' endif;'|| CHR(10) ||
'END;'
WHERE DTD_ELEMENT = 'PATIENTEXTN_EXTENSION' AND PROFILE = 'ICH-ICSR V2.1 MESSAGE TEMPLATE - FDA PIP';
Commit;
Note that, the above SQLs need to be customized based on the type of the field. For example, if a user defined device extension is being added, then the table name parameter in SQL# 2 will be
"ESM_IMP.F_WRITE(:REPORT_ID,:PARENT_ELEMENT,:DTD_ELEMENT,:PROFILE,''CASE_PROD_DEVICE'',"UD_TEXT_1",l_value);"
Test the Custom Extension:
Login to Siebel AECM, Create a Product Issue and populate the custom extension field that was added. Click Send to Safety button. A message is sent to integration pack JMS queue.
On integration pack's Enterprise Manager Console, select the instance that was triggered. Verify the input payload at the ReportDrugSafetyReportSEBLReqABCSImpl. Ensure Siebel AECM ABM has the custom field.
Verify the input payload (EBM) ReportDrugSafetyReportEBS. Ensure that EBM custom field PatientExtension has the appropriate value populated.
Verify the output of ReportDrugSafetyReportArgusProvABCSImpl. Ensure that Argus E2B file has the custom field at the appropriate place.
Login to Oracle Argus Safety. Verify that the E2B case has the custom extension field with correct value.
The following DVMs are added to the Foundation Pack to support additional fields you might send to Oracle Argus Safety. If you have added any of these fields to Siebel AECM, you should use the DVM when populating the EBM.
| DVM Type | DVM Column Name | Comments |
|---|---|---|
| DRUGSAFETYREPORT_OBSERVESTUDYTYPE | COMMON, ARGUS_01 | This maps to Case Form / General / Study Information / Observe Study Type in Oracle Argus Safety. |
| OCCUPATION | COMMON, ARGUS_01 | This maps to Case Form / Patient / Patient Details/Occupation in Oracle Argus Safety. |
| RACE | COMMON, ARGUS_01 | This maps to Case Form / Patient / Patient Information / Ethnicity in Oracle Argus Safety. |
| DRUGSAFETYREPORT_AGEGROUP | COMMON, ARGUS_01 | This maps to Case Form / Patient / Patient Information / Age Group in Oracle Argus Safety. |
| DRUGSAFETYREPORT_DRUGACTIONTAKEN | COMMON, ARGUS_01 | This maps to Case Form / Products / Product Details / Action Taken in Oracle Argus Safety. |
| DRUGSAFETYREPORT_DRUGFORMULATION | COMMON, ARGUS_01 | This maps to Case Form / Products / Product Information / Formulation in Oracle Argus Safety. |
If you have more than one server for Siebel AECM, you can use the steps provided in this section for configuring multiple AECM environments to send product issues from multiple Siebel AECM servers to Oracle Argus Safety.
Perform the following steps to configure additional Siebel AECM instances:
Update AIA System Registry:
Navigate to the AIA Console URL: http://<server name>:<portnumber>/AIA.
Log in with server admin user name and password.
Navigate to Setup, then to Systems.
Click Create to create an additional row for each instance of Siebel AECM to be configured. As an example, add one extra instance of AECM named SEBLCLIN_02 (assuming it as original instance of AECM is SEBLCLIN_01).
Enter values in the following mandatory fields:
| Field | Description |
|---|---|
| Internal ID | This is the Siebel Enterprise Server Name (For example: siebel). Contact the Siebel administrator for getting this value. |
| System Code | A unique value to identify this system. This is used for DVM and XREF lookups as well as routing. |
| System Type | A unique value to identify the system type. |
Modify the DVM and Cross Reference (XRef) entries. The Domain Value Maps (DVMs) are stored under $AIA_HOME/AIAMetaData/dvm folder. Cross References (XRefs) are stored under $AIA_HOME/AIAMetaData/xref folder. You need to modify the following DVMs and XRefs:
DRUGSAFETYREPORT_CASEID.xref
STATE.dvm
COUNTRY.dvm
DRUGSAFETYREPORT_REPORTTYPE.dvm
DRUGSAFETYREPORT_QUALIFICATIONCODE.dvm
GENDER.dvm
DRUGSAFETYREPORT_ADVERSEEVENTREPORTEDOUTCOME.dvm
DRUGSAFETYREPORT_DEVICEREMEDIALACTION.dvm
UNIT_OF_MEASURE.dvm
DRUGSAFETYREPORT_ADVERSEEVENTSEVERITY.dvm
DRUGSAFETYREPORT_DRUGADMINISTRATIONROUTE.dvm
DRUGSAFETYREPORT_DEVICEUSE.dvm
DRUGSAFETYREPORT_DEVICEOPERATOR.dvm
DRUGSAFETYREPORT_OCCURRENCELOCATION.dvm
DRUGSAFETYREPORT_STATUS.dvm
In the XRefs add an additional column for SEBLCLIN_02 (second instance of AECM and any other AECM instances, as you may require). In DVMs add additional Column Name and alter to add the column values appropriately.
The following code is an example for COUNTRY.dvm and DRUGSAFETYREPORT_CASEID.xref. You may need to modify certain values as per your target environment.
COUNTRY.dvm
<?xmlversion='1.0' encoding='UTF-8'?>
<dvm name="COUNTRY" xmlns="http://xmlns.oracle.com/dvm">
<description>Country LoVs</description>
<columns>
<column name="COMMON"/>
<column name="SEBLCLIN_01"/>
<column name="SEBLCLIN_02"/>
<column name="OC_01"/>
<column name="SEBL_01"/>
<column name="ARGUS_01"/>
</columns>
<rows>
<row>
<cell>United States</cell>
<cell>USA</cell>
<cell>USA</cell>
<cell/>
<cell/>
<cell>US</cell>
</row>
</rows>
</dvm>
DRUGSAFETYREPORT_CASEID.xref
<?xmlversion="1.0" encoding="UTF-8" ?>
<!--Upgraded by Xref Upgrade Utility 1.0 -->
<xref xmlns="http://xmlns.oracle.com/xref">
<table name="DRUGSAFETYREPORT_CASEID">
<description></description>
<columns>
<column name="COMMON"/>
<column name="SEBLCLIN_01"/>
<column name="OC_01"/>
<column name="SEBLCLIN_02"/>
</columns>
</table>
</xref>
For more information about how to update MDS and upload updated DVMs and XRefs to MDS, see Oracle Fusion Middleware Developer's Guide for Oracle Application Integration Architecture Foundation Pack 11g Release 1, "Building AIA Integration Flows", "Updating MDS".
Note that, any change made to the MDS will overwrite the files. However, the data in the Xref_data table will not be affected.
You can verify DVMs and XRefs by accessing these files in MDS. You can also verify DVMs in SOA Composer.
Update AIAInstallProperties.xml.
Update the AIAInstallProperties.xml file in the $AIA_INSTANCE_HOME/config to add the following SEBLCLIN_02 database entry as a child node of /properties/participatingapplications.
Remember to replace the variables in the curly braces {} with the actual values.
<sc>
<server>
<internal>
<id>{SID}</id>
</internal>
<eai>
<username>{username}</username>
<password>{password}/password>
</eai>
<host>{host }</host>
<port>{port}</port>
<version>8.1.1.6</version>
<Language>enu</Language>
<InternetProtocol>http://</InternetProtocol>
</server>
</sc>
Encrypt the AIAInstallProperties password by running the following commands:
source $AIA_INSTANCE_HOME/bin/aiaenv.sh
cd $AIA_HOME/util
ant -f updateStore.xml addToStore -DAdminUsername=< weblogic Admin username> -DAdminPassword=<weblogic admin password>
A popup window is displayed. Enter values for:
Username: Admin user username for SEBLCLIN_02 URL
Password: Admin user password for SEBLCLIN_02 URL
Path: Xpath of the SEBLCLIN_02 database password field in the AIAInstallProperties.xml.
For example: /properties/participatingapplications/sc2/db/password
This updates the encrypted password in the MDS as well as in the $AIA_INSTANCE_HOME/config file. Inspect the AIAInstallProperties.xml file in $AIA_INSTANCE/config to verify that the password for SEBLCLIN_02 database is encrypted.
Modify the service configurations. Navigate to ${AIA_HOME}/aia_instances/inst1/AIAMetaData/config and open AIAConfigurationProperties.xml for modification.
Under Session Pool Manager properties, add the following properties:
<!--=== Specific values for Siebel Clinical Trial Management SEBLCLIN_02 === -->
<Property name="SEBLCLIN_02.EndpointURI">https://<siebelserverhostname>:<siebelserverpost>/eai_enu/start.swe?SWEExtSource=SecureWebService&SWEExtCmd=Execute&WSSOAP=1</Property>
<Property name="SEBLCLIN_02.UserId"><username></Property>
<Property name="SEBLCLIN_02.Password">participatingapplications.sc2.server.eai.password</Property>
<Property name=" SEBLCLIN_02.PredictExpiration_Idle">780000</Property>
<Property name="SEBLCLIN_02.PredictExpiration_Age">82800000</Property>
<Property name="SEBLCLIN_02.InvalidSessionErrorCodes">10944642|SBL-BPR-00162|SBL-DAT-00175|11338608|SBL-UIF-00880</Property>
<Property name="SEBLCLIN_02.ClassName">oracle.apps.aia.core.sessionpool.CRMSiebelSession</Property>
Upload the AIAConfigurationProperties file to MDS using the following steps:
Modify the AIAConfigurationProperties.xml at $AIA_INSTANCE_HOME/AIAMetaData/config
Edit $AIA_INSTANCE_HOME/config/UPdateMetaDataDP.xml to include AIAConfigurationProperties.xml. Following is a sample UpdateMetaDataDP.xml:
<?xmlversion="1.0" standalone="yes"?>
<DeploymentPlan component="Metadata" version="3.0">
<Configurations>
<UpdateMetadata wlserver="fp" >
<fileset dir="${AIA_INSTANCE}/AIAMetaData">
<include name="config/AIAConfigurationProperties.xml"/>
</fileset>
</UpdateMetadata>
</Configurations>
</DeploymentPlan>
Save the changes. Run the following commands:
source $AIA_INSTANCE_HOME/bin/aiaenv.sh
cd $AIA_HOME/Infrastructure/Install/config
ant -f UpdateMetaData.xml
Set up a new reporting destination in Argus Console. Enter the following values for the fields:
Agency Information Tab:
Agency Name - AECM_ARGUS_INTEGRATION2
Local Company Contact Tab:
Company Name - INTEGRATIONS2
EDI Tab:
Agency Identifier - SEBLCLIN_02
For more information about the fields and the values that you need to enter in Agency Information, Local Company, and EDI tab; apart from the one mentioned above, refer Oracle® Device and Drug Adverse Event Data Integration Pack for Siebel Adverse Event Complaint Management and Oracle Argus Safety, Installation Guide, Release 11.1, "Configuring Argus for Using Extension Profile".
You can monitor the SOA composite instances at run time using the composite sensors. Composite sensors enable you to search for instances using certain parameters. For example, a composite instance fails at some point in the flow. As an admin user, you can search for that failed composite instance on Enterprise Manager, using a pre-defined composite sensor as a search parameter. For example, you can use ProductIssueNumberSensor to search for all composite instances that have a given Product Issue Number.
To perform a composite instance search follow these steps:
Navigate to the component. For example: ReportDrugSafetyReportSEBLReqABCSImpl
Select the Instances tab and click Add Fields button in the Search parameter selection area. Using Add Fields button, you can add additional search parameters such as Product Issue Number or Case ID.
The following composite sensors are available to monitor composite instances during the runtime:
| Field Name | Component Name | Composite Sensor Name |
|---|---|---|
| Product Issue Number | ReportDrugSafetyReportSEBLReqABCSImpl | ProductIssueNumberSensor |
| Product Issue Number | ReportDrugSafetyReportResponseSEBLProvABCSImpl | ProductIssueNumberSensor |
| AE Case ID | ReportDrugSafetyReportResponseSEBLProvABCSImpl | AECaseIdSensor |
The screen below shows composite instance search feature, where all composite instances matching a specific Product Issue Number can be searched using ProductIssueNumberSensor. Thus, you can easily find the specific composite instances.
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