Use this patch set to install Oracle® Health Sciences Adverse Event Integration Pack for Oracle Health Sciences InForm and Oracle Argus Safety (Adverse Event: InForm and Argus Safety integration) Release 1.0.1.
Contents: Overview | Problems Addressed | List of Files Delivered in the Patch | Downloading the Patch | Installing the Patch | Uninstalling the Patch
This patch set contains fixes to the Adverse Event: InForm and Argus Safety Integration. It contains changes to support Oracle Health Sciences InForm 6.0 and Oracle Argus Safety 7.0.2.
This section describes the bugs fixed in this patch. The descriptions include two subsections: Before and After.
The Adverse Event: InForm and Argus Safety integration 1.0.1 patch set includes the following bug fixes:
An additional product tab was created during E2B imports. The second product tab contained the information about the product such as, dosing. Follow-up would go into the first tab that had information entered in the Argus Product setup.
An additional product tab is not created during E2B imports.
E2B follow-up import did not work for the CASE_PROD_DEVICES.UD_TEXT_7 extension field. When data for this field is populated and you send information from InForm to Argus for this user-defined field, you will not be able to accept the follow-up into the case.
E2B follow-up can now be accepted when it contains information for the CASE_PROD_DEVICES.UD_TEXT_7 extension.
When InForm user reports multiple primary causes of death and autopsy-determined causes of death for a given subject, the integration was interspersing each type of cause in the E2B. This resulted in a message that does not conform to the underlying message schema definition.
Note: There is no impact on the functionality of the integration.
When InForm user reports multiple primary causes of death and autopsy-determined causes of death for a given subject, the integration writes all primary causes of death followed by all autopsy-determined causes of death. These message conforms to the underlying message schema definition.
Integration writes an empty extension element < regsubmitindicator_extension/ > in the E2B file to Argus Safety. This extension element was not used by InForm to Argus Safety integration and hence there is no impact on functionality.
Integration does not write empty extension element < regsubmitindicator_extension/ > in the E2B file.
When dosage unit values were not specified in InForm (for example, grams or milligrams), Argus Safety E2B import process did not display an import warning. It imported dosage values without units to Argus Case Form.
When dosage unit values are not specified in InForm, Argus Safety E2B import process displays an import warning for missing unit values. Dosage values without units are not imported into Case Form fields > Products > < Product Name > > Dosage Regimens > Dose and Daily Dosage.
Argus 7.0.2 was not supported by the integration.
Argus 7.0.2 is now supported in addition to Argus 7.0.1.
During InForm trial design, study designer mapped Subject_AdverseEvent/RelatedtoStudyDrug indicator to a form field to indicate whether an adverse event was caused by the study drug.
During the trial run time, when InForm user selected a value that sets Subject_AdverseEvent/RelatedToStudyDrug indicator to True, the integration interpreted the study drug to be interacting and it incorrectly assigned study drug\x92s characterization code as 3.
Interacting does not mean that the study drug was related to the adverse event. An interacting drug is a non-study drug that interacted with the study drug and is believed to have caused the adverse event.
During InForm trial design, study designer maps Subject_SuspectDrug/SuspectDrug_Interacting indicator to a form field to indicate whether a given non-study drug caused the adverse event by interacting with the study drug.
During the trial run time, when InForm user enters a value that sets Subject_SuspectDrug/SuspectDrug_Interacting indicator to True, the integration assigns non-study drug\x92s characterization code as 3.
InForm 6.0 was not supported by the integration.
InForm 6.0 is now supported in addition to InForm 4.6 and InForm 5.5.
This patch is distributed as a zip file. To locate and download this patch:
Sign in to My Oracle Support at http://support.oracle.com.
Click the Patches & Updates tab.
The Patches and Updates page opens and displays the Patch Search region.
In the Patch Name or Number field, enter the primary bug number (16523094) fixed by this patch.
Click Search to execute your query.
The Patch Search Results page opens.
Click the patch ID number.
The system displays details about the patch. In addition, you can view the Readme file before downloading the patch.
Click Download.
A dialog box opens.
Choose to save the file, browse to a temporary directory where the file is to be downloaded, and click Save.
Transfer the patch zip file to the necessary servers.
This section contains the following topics:
On Unix, execute the following commands:
$ cd < AIA_HOME >
$ chmod -R 777 services/
$ chmod -R 777 data/
On Windows, navigate to the following directories. Right-click on the directory name, select Properties, and deselect Read-only attribute in the context menu.
For example,
On Linux: /slot/oracle/16523094
On Windows: D:\oracle\16523094
On Linux: source aiaenv.sh
On Windows: aiaenv.bat
For Unix:
$ export OPATCH_HOME=$AIA_HOME/OPatch
$ export PATCH_HOME=< location where you unzipped patch >
$ export PATH=$OPATCH_HOME:$PATH
For Windows:
$ set OPATCH_HOME=%AIA_HOME%/OPatch
$ set PATCH_HOME=< location where you unzipped patch >
$ set PATH=%OPATCH_HOME%:%PATH%
apply command based on the platform:
For Unix: $ opatch apply $PATCH_HOME -invPtrLoc $AIA_HOME/oraInst.loc -oh $AIA_HOME -jre < jre location >
For Windows: C:> opatch apply %PATCH_HOME% -invPtrLoc %AIA_HOME%\oraInst.loc -oh %AIA_HOME% -jre < jre location >
Note: jre_location is: < Middleware_Home > /jdk/jre or $JAVA_HOME.
For any questions or problems, contact Oracle Support for AIA.
To deploy the changes, perform the following:
The patch deployment plan is available at $PATCH_HOME/custom/scripts/Patch_16523094DP.xml
To run this, navigate to the $PATCH_HOME location and execute the following commands:
On Linux: $ ant -f $AIA_HOME/Infrastructure/Install/AID/AIAInstallDriver.xml -DDeploymentPlan=$PATCH_HOME/custom/scripts/Patch_16523094DP.xml -DPropertiesFile=$AIA_INSTANCE/config/AIAInstallProperties.xml -l $PATCH_HOME/16523094.log
On Windows: % ant -f %AIA_HOME%\Infrastructure\Install\AID\AIAInstallDriver.xml -DDeploymentPlan=%PATCH_HOME%\custom\scripts\Patch_16523094DP.xml -DPropertiesFile=%AIA_INSTANCE%\config\AIAInstallProperties.xml -l %PATCH_HOME%\16523094.log
For any questions or problems, contact Oracle Support for AIA.
This patch provides new profile scripts for Argus. Follow the steps in Setting Up Argus E2B Profile section in the Oracle\xAE Health Sciences Adverse Event Integration Pack for Oracle Health Sciences InForm and Oracle Argus Safety Installation Guide Release 1.0.1.
There are two parts to rollback the patch:
To restore prepatch files:
On Linux: % opatch rollback -id
< patchnumber > -invPtrLoc $AIA_HOME/oraInst.loc -oh $AIA_HOME -jre < jre location >
On Windows: % opatch rollback -id
< patchnumber > -invPtrLoc %AIA_HOME%\oraInst.loc -oh %AIA_HOME% -jre < jre location >
For any questions or problems, contact Oracle Support for AIA.
To redeploy prepatch content, run the following command:
On Linux: $ ant -f $AIA_HOME/Infrastructure/Install/AID/AIAInstallDriver.xml -DDeploymentPlan=$PATCH_HOME/custom/scripts/Patch_16523094DP.xml -DPropertiesFile=$AIA_INSTANCE/config/AIAInstallProperties.xml -l $PATCH_HOME/16523094.log
On Windows: % ant -f %AIA_HOME%\Infrastructure\Install\AID\AIAInstallDriver.xml -DDeploymentPlan=%PATCH_HOME%\custom\scripts\Patch_16523094DP.xml -DPropertiesFile=%AIA_INSTANCE%\config\AIAInstallProperties.xml -l %PATCH_HOME%\16523094.log
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