|Oracle® Argus Safety Release Notes
Part Number E26222-01
Oracle Argus Safety Patch 7.0.1 contains new features, described in the Features Implemented section. See the Issues addressed in the Argus Safety 7.0.1 Patch section for a list of issues resolved by installing this patch. This patch is distributed in the form of a zip file p13869833_70_WINNT.zip. See Installing the Patch for complete instructions.
|Affected Features:||Advanced Conditions, Argus Affiliate, Argus Console, Argus Interchange, Argus Safety Services, Audit Log, Case Actions, Case Form, Dashboard Database, DLP, Documentum Integration, EOSU Tool, Expedited Reports, Installation, Interfaces, Letters, Login, MedDRA Recode, Periodic Reports, Regulatory Reporting Rules, Reports, System Reports, Utilities, and Worklist|
|Patch component(s):||Argus Safety Web Server, Argus Safety Report Server, Argus Safety Transaction Server, and Argus Safety Database Server|
|Version:||This is the first version.|
|Prerequisites:||Argus Safety 7.0|
The following is certified in this release, in addition to the base environment specified for Argus Safety 7.0 and 188.8.131.52:
Windows Server 2008 R2 64 bit for all Argus Safety components installed on the following boxes:
Oracle Enterprise Linux 6.1 UEK for Database server
IIS 7.5 on Windows Server 2008 R2 64 bit for Argus Safety Web / Report Server
Axway Interchange (Cyclone) version 5.10
Oracle Database 184.108.40.206 (Enterprise/Standard) and 220.127.116.11 - AL32UTF8 character set for Database server
Oracle Virtual Machine 2.2.2
Internet Explorer 9.0 browser
DFC 6.5 SP3 for Documentum
Please refer to the Oracle Argus Safety 7.0.1 Installation Guide for more detailed information about the technology stack.
This section describes the new features introduced in Oracle Argus Safety 7.0.1.
The purpose of this enhancement is to provide pharmaceutical companies and CROs the ability to determine the total effort spent on case processing by individuals across different workflow routes. CROs can use this data for billing their clients on the total amount of time spent on their cases by CRO employees.
Argus Safety has been enhanced to capture the following details during Case Processing:
Case Open Date
Case Closed Date
Mode of Opening the Case (Edit/Read-Only)
Is Modified (indicates whether the case is modified or not)
In some scenarios where users may not close the case explicitly but may use logout OR the user's session may be terminated by the Administrator using Reset User functionality. In such cases, the user's logout date is populated as Case Closed date. The above data is not captured when the case is opened through background/batch process.
Argus Safety captures the following data while the case is assigned or unassigned to a user from a workflow state:
Case Assigned Date
Case Unassigned Date
User to whom the case is assigned
Workflow State (the state to which the case is routed)
FDA CDRH has developed the Evaluation Code terminology for the reporting of medical device evaluations by the manufacturer. Three CDRH term sets, covering Evaluation Method Codes, Evaluation Result Codes, and Evaluation Conclusion Codes, are specified in the NCI thesaurus (NCIt) . Argus Factory data is updated with the Evaluation codes as per Evaluation Code Disposition file.
The purpose of this enhancement is to provide Multi-tenancy feature which does not require Oracle Web Center as Portal Server. Companies can avoid extra cost of buying and configuring Portal server by installing Argus Global Application along with Argus Safety Application.
The Argus Safety Installer has been enhanced to include Argus Global Application in the Components list. On marking the Argus Global Application component, an additional step appears in the Setup screen with a configuration parameter.
Select where the Argus Global Application will be deployed, from one of the following options:
Argus Safety Web Server (default option)
Oracle Web Center
If the Argus Safety Web Server option is selected, global modules are installed on the same web server as Argus Safety Web. On the other hand, if the Oracle Web Center option is selected, all the portlet files which are required for deployment on the Web Center are copied.
A new user role, called Global Admin, has been introduced in the following screens to allow specific users to access the Argus Global Application:
Argus Console > User Management
Global User Management > Synchronize User Attributes > Synchronized Value
'Global Admin' user role is assigned to the Global Users, managing users for selected enterprises. Users having Global admin role and Console application can access Global Enterprise Management and Global User Management modules of the Argus Global application.
Points to Note:
A Global user can view only those enterprises for which the user has access to 'Global Admin' and 'Argus Console'.
A Global user can view the users belonging to only those enterprises for which the user has 'Global admin' and 'Console' access.
A 'Global Admin' user role is assigned to 'Admin' user by default. Global admin role can be assigned or unassigned by users having this role in the current enterprise.
A Global Admin role is printed in User Management Print template and Global User Management Print template as a part of the User role section.
The purpose of this requirement is to automatically assign an unassigned case to a user when opened in edit mode in the below mentioned scenarios:
The case is opened in Edit mode from Worklist Options(excluding Intake and Literature intake) or Case actions (Open, Medical Review. Coding review), Dashboard > Personal Argus Status, Active case options by a user
The case is opened after hitting the Book-in button by a user
The copied case is edited by a user
In order to enable the Oracle Argus customers to leverage the already available periodic reports, Periodic Safety Update Report (PSUR) and Clinical Trial Periodic Report (CTPR) are enhanced to support the following features for the purpose of creating the DSUR:
Identification of SUSAR Events
Identification of Primary Event
Identification of Special Interest AE
The aggregate reports (Case Line Listing, CIOMS II Line Listing and Case Data Analysis) are also enhanced to support these features. Case Data Analysis (CDA) reports are enhanced to support 3 columns X 3 rows data stratification.
The Product Configuration in Argus Console (Business Configuration > Products and Licenses) is enhanced to capture the DIBD element.
This field is auto populated as the earliest Award Date of all the Investigational licenses for that product, irrespective of the authorization country, only when the field does not already contain a value.
An upgrade script is made available to populate the new field with the earliest Award Date of all the Investigational licenses for that product.
Argus Safety MedDRA Web Service Integration supports the following:
Multiple encoding results can be returned in the response from the external MedDRA web service
MedDRA J encoding by accepting and encoding the terms with MedDRA J hierarchy
E2B Import framework allows creation of cases for PMDA E2Bs for reporting categories - E, F, G, L, M, N, O & P which do not have REACTION block in the E2B XML.
E2B Import framework now adds a placeholder event in the case - "有害事象なし" (No adverse event) to allow case creation for such PMDA E2Bs.
E2B Import framework supports all the other Japanese case table columns which are not directly covered by PMDA E2B Import profile logic. In earlier releases, only those Japanese case columns were supported which were directly used by PMDA E2B Import profile logic.
The maximum number of attachments allowed in a case is extended to 500 at following places:
Case Form > Notes and Attachments tab > Notes and Attachments section
Affiliate > Local Event > Attachment section
Worklist > New and Open screen > Filter drop-down now displays a new option as "Attachment Classification" (添付ファイルの分類) as the last option. When a user chooses this option in Filter drop-down and goes to "Value" type-ahead textbox, then all the values from Attachment Classification code list accessible to the user are displayed in the "Value" field.
DLP is used by customers to report data for periodic reports based on as of that day case revision. Currently, customer face performance issues while running periodic reports on DLP database. This problem is mainly attributed to the way the case revisions are stored, identified, and then retrieved for DLP reporting. The design has been enhanced to smoothen this process for better performance of periodic reports on DLP. The new design does not impact the report output data or the functional behavior of the product.
For optimal performance of MedDRA recode on DLP Enabled safety database, please follow the steps outlined below:
Connect as dlp_stage in Argus Safety database and disable trigger t_scase_master_count.
ALTER TRIGGER t_scase_master_count DISABLE;
Connect as dlp_owner in DLP database and disable DLP ETL job.
DECLARE l_job_id BINARY_INTEGER; BEGIN SELECT job INTO l_job_id FROM all_jobs WHERE what LIKE '%pkg_dlp_etl.p_process_dlp_cases(l_rc);%'; DBMS_JOB.broken (l_job_id, TRUE); END;
Start the Recode Tool. Perform the desired operations.
Enable the trigger that was disabled in step 1.
ALTER TRIGGER t_scase_master_count ENABLE;
Enable the job that was triggered in step 2.
DECLARE l_job_id BINARY_INTEGER; BEGIN SELECT job INTO l_job_id FROM all_jobs WHERE what LIKE '%pkg_dlp_etl.p_process_dlp_cases(l_rc);%'; DBMS_JOB.broken (l_job_id, FALSE); END;
PMDA E2B reports can now be imported so as to enable intake / exchange of Japanese case data for Japanese customers. Tag-by-tag E2B Import is now supported for PMDA DTD profile, in order to create a full case with English as well as Japanese fields. Other non-J E2B (ICH, FDA and EMEA) profiles will populate J fields during E2B Import only if Argus J module is enabled. The ESM Service Receive process performs mandatory (M) and mandatory for completion report (MC) element validations for Japanese E2B reports based on the reporting category (J.4a - mhlwadmicsrcasenumclass) and completion report flag (J.6 - mhlwadmicsrcompleteclass) of the incoming E2B.
The PMDA Research reports (Research AE/Infection Report and Measures in foreign countries report) are submitted daily to PMDA requires limited data to be captured and reported. This feature provides simplified data capture capabilities for Japanese users entering data for Literature Research Cases.
This feature provides ability to copy data from English fields to Japanese fields and certain Japanese fields to English fields in Case Form. The PMDA allows some data to be submitted in English for a foreign case.
Seiyakukyo Line Listing report is a periodic report format specified by JPMA. This report is to be used by pharmaceutical companies in Japan to send case reports to medical institutions. It is mandated by PMDA to report study cases to medical institutions and is required to be fully compliant in Japan. It has a configuration screen, generation, publishing and handling process as other Japanese periodic reports.
This section describes the bugs fixed in this patch. For details regarding a specific bug, please see the Bug Database.
|10173408||Cannot print Acknowledgement for nullification of deleted cases|
|12432372||Unable to configure dynamic workflow or save data|
|11844183||Pure Insight users cannot access Insight using Argus Safety URL|
|10132424||Case Data Analysis Report 'Chart' option intermittently displays a login screen|
|11853794||ESM fails to update IMP_CHECK column in ESM_DIFFERENCE_REPORT table|
|12325558||EOSU Batch Case Close not archiving cases properly if custom workflow state is used|
|12685697||E2B Import of an open label Study case may result in extra products in the case|
|12822555||Accepting EMA report failed when ‘senderdiagnosis' has data|
|12938203||Unprocessed files from New Case from Image are not restored with original name|
|12950660||Error in saving Case Form configuration for Drug and Event dictionary|
|12945766||Empty MedDRA tables are not imported during Copy Config execution|
|13010165||CIOMS-II with Product Family configured as a part of PSUR does not show Event Assessment|
|13011839||CTPR/PSUR Expedited reports not getting generated on DLP using AG Service|
|12677909||CIOMS Line Listing Report taking more time than SLA|
|12998939||MedDRA browser shows wrong coded version|
|13073075||AG Service User not getting updated through default enterprise|
|13033115||Admin User is not having Insight access in the enterprise of Insight 7.0|
|13421210||Runtime Error due to incorrect date in Argus Affiliate|
|13404662||Overwriting the MedDRA Dictionary causes Console to show incorrect selected dictionary|
|13404521||ESM Service is occasionally processing incoming E2B files twice|
|13373057||Second term is missing from CIOMS-I Box 23|
|13104024||User Configuration Report is showing multiple site security rows|
|13100343||Argus is generating a narrative with invalid characters by using the apostrophe|
|12963304||Manual entry of duration of hospitalization not supported in Argus 5.x|
|12682104||Orphaned records are created in the CMN_REG_REPORTS table after generating the E2B Preview|
|12676752||Allow Case Save without requiring tabbing out to save the data|
|13467442||Unable to import E2B files with S-JIS and UTF-16 encoding|
|13586801||Re-transmit failed, E2B Report did not transmit and got stuck on report generation|
|13620217||Worklist owner and assigned mixed up in some code references|
|13644009||Performance issue when selecting Studies in the Bookin screen|
|13632004||Reporter Salutation placeholder is not showing data in Affiliate Letters|
|13626527||Case Form Print does not print Patient data on legacy cases|
|13555332||Application is saving End Date in the database for Vaccine products|
|13556605||NDA Report Generation fails when Event Term has Maximum Data|
|11828499||Seaches for Studies in Projects containing many studies causes performance lag|
|13768715||In Case Routing, 'Any' is getting displayed when there are no available states|
|13681659||User is unable to save the case when more than 1500 Lab Tests are entered|
Case Deletion Nullification Acknowledgement Print was not showing errors/warnings.
Case Deletion Nullification Acknowledgement Print is showing errors/warnings.
When adding the value 0.01 for the Time (Day) Norm parameter and the value 0.03 to the Time (Day) Max parameter in the Workflow rule, the system used to reset both values to 0.0.
The system does not round off the values entered for Time (Day) Norm and Time (Day) Max Workflow rules paramaeters in the Workflow configuration .
Argus Console - Workflow Configuration
Argus Insight did not open from Argus Safety URL, when the user had access to Argus Insight and the default application was Argus Insight.
User can access Argus Insight from the Argus Safety URL.
When printing the Case Data Analysis (CDA) report using the chart option, the behavior was inconsistent. Some users were able to see a chart, some users were not able to see a chart, while for others, the issue was intermittent.
Users are able to print the Case Data Analysis (CDA) report using the chart option consistently, without any problems.
Case Data Analysis Reports
An error message "ESM failed to update the imp_check column in esm_difference_report table" was observed when a user with product security was trying to import to case in Argus application.
Product and Study security is applied on E2B Pending screen, which ensures that only those E2B files will be displayed in E2B Pending screen for which user has access to.
EOSU external tool batch case close was not archiving cases properly. However, cases were in Locked state if the custom non-closed workflow state was used.
After running batch case close process of EOSU, Case is in Closed state.
End of Study Unblinding (EOSU)
An open label study drug containing products configured with multiple licenses that share the same license number and identical award dates could result in multiple study drug tabs being created for the case during the import process.
E2B import process creates the case with same number of study products as specified in the study configuration.
Accepting EMA report from E2B Pending screen failed when senderdiagnosis had data.
The EMA report with senderdiagnosis data is successfully imported from E2B Pending screen .
Unprocessed files from New Case from Image were restored by adding an extra "." along with original file name.
Unprocessed files are restored with the original name in Case Actions > New Case from Image.
If a user changed the drop-down value for drug or event dictionary in Argus Console > System Configuration > Common Profile Switch, and saved, the system gave an error.
The system saves the settings for Dictionaries in Common Profile Switch without any error.
Argus Console > System Configuration > Common Profile Switch
While executing the Copy Config Tool, three MedDRA tables MEDDRA_SPEC_CAT,MEDDRA_SPEC_PREF_COMP, MEDDRA_SYNONYMS had not been exported from the Source and subsequently imported into Target database. The tables were empty in the Source database.
The MedDRA tables listed above are getting exported and imported into the Target database.
Markings for SUSAR, Special Interest and Primary Event were not printed for unblinded cases in CIOMS-II configured as a part of PSUR. This was observed when CIOMS-II configuration had Select a Product Family set to a Product family that was configured in the study.
Markings for SUSAR, Special Interest and Primary Event are printed for unblinded cases in CIOMS-II configured as a part of PSUR, when CIOMS-II configuration Select a Product Family is set to a Product family that is configured in the study.
When the PSUR/CTPR reports were being generated using the Batch Periodic Reports process of AGService, the expedited reports that were part of PSUR/CTPR, were getting generated on Argus database, even though the reports were configured to run on DLP.
When periodic reports are run on DLP, child expedited reports are also generated on DLP.
The CIOMS-II Line Listing Report was taking more time than what was committed in the SLA.
The CIOMS-II Line Listing Report is generated within the time committed in the SLA.
CIOMS Line Listing Reports
The MedDRA browser was displaying the incorrect coded version on clicking the Encode button from Patient > Lab Data.
The MedDRA browser is displaying the correct coded version on clicking the Encode button from Patient > Lab Data.
The AG Service user was not getting updated through the default enterprise, if the user had a different User ID in different enterprises.
The AG Service user is updated through the default enterprise if the user has a different User ID in different enterprises.
The Admin User was not able to log in to the Argus Insight, if the Enable Insight module was unchecked and Admin user password was reset.
The Admin User is able to log in to the Argus Insight, if the Enable Insight module is unchecked and Admin user password is reset.
On entering incorrect date in LAM | Event Information | Onset date field, a VB Script runtime error appeared.
On entering incorrect date in LAM | Event Information | Onset date field, the VB Script runtime error does not appear.
MedDRA recode from 14.0 to 14.1 updated the hierarchy/terms to match 14.1, but not the dictionary version. The terms were still shown as 14.0 in the application.
The MedDRA recode from 14.0 to 14.1 updates the hierarchy/terms and the dictionary version to match 14.1.
Occasionally, ESM Service was processing the incoming E2B files twice and was writing duplicate message-received error in the ESM import log file when it was processing the E2B file for the second time.
ESM Service processes the incoming E2B file only once.
When more than two Historical Drugs were entered in the Other Relevant History, the second entry was consistently omitted from CIOMS-I report in Box 23.
All the Historical Drugs entered in the Other Relevant History are printed in Box 23 of the CIOMS-I report.
When the Print All option was selected for the User Configuration Report, multiple entries per site were shown under Site Security for all users.
When the Print All option is selected for the User Configuration Report, a single entry per site is shown under Site Security.
Argus was generating a narrative with invalid characters when using an apostrophe (') in the narrative phrase.
Unicode characters are displayed properly on the Case Form-Auto Narrative and Abbreviated Narrative.
Users were unable to capture the duration of Hospitalization on the Events tab, unless they had specific Start and Stop Dates for hospitalization.
Users are able to capture the duration of Hospitalization on the Events tab, even if they do not have specific Start and Stop Dates for hospitalization.
Orphaned records were getting created in the CMN_REG_REPORTS table when the user generated the preview draft of E2B. These records were not deleted when the user closed the E2B Draft.
Records created while generating the preview E2B draft get deleted when the user closes the report.
When the user entered data in any field and clicked the Save button without tabbing out to another field, the data was not saved.
When the user enters data in any field and clicks on Save button without tabbing out to another field, the data is now getting saved.
Shift-JIS encoded PMDA E2B files and UTF-16 encoded Non-PMDA E2B files were not imported by Interchange Service.
Shift-JIS encoded PMDA E2B files and UTF-16 encoded Non-PMDA E2B files are now imported by Interchange Service.
Retransmission failed when any Failed E2B report was re-transmitted from the Bulk E2B Transmit screen using the Re-Transmit option, with preferred route as Fax.
Retransmission can be done for failed E2B report from Bulk E2B Transmit screen using preferred route as Fax.
The application displayed Case Owner in Assigned User field in the following pages:
Case Routing dialog
Dashboard for case workflow
Workflow email subject
Case Summary dialog
Open Case Summary report
The application displays Assigned User in Assigned User field in the following pages:
Case Routing dialog
Dashboard for case workflow
Workflow email subject
Case Summary dialog
Open Case Summary report
The system was taking a long time (> 10 minutes) to return the studies or did not return the results and turned into not responding state when searching for a study that contained large number of Study Centers in the Clinical Trial Selection dialog during the initial case entry .
During the initial case entry, when the user is searching for a study that contains large number of Study Centers in the Clinical Trial Selection dialog, the system returns the results much faster than before.
The Reporter Salutation placeholder did not display data in Affiliate Letters.
The Reporter Salutation placeholder displays data in Affiliate Letters.
Legacy cases that had no patient information could throw an error while attempting to print Patient information.
Legacy cases that have no patient information no longer throws an error while printing Patient information.
The application was saving the Start Date in the Start Date as well as in the End Date for the Vaccine products in the database.
The application saves the Start Date in only the Start date field for the Vaccine products in the database.
NDA report generation was failing with report execution error when the report included a case which had a submitted expedited report with maximum data for description of event reported.
NDA report is generated successfully when the report includes a case that has a submitted expedited report with maximum data for description of event reported.
Periodic Reports - NDA
During New Case entry, if the study relevant to a case was in a Project with a large number of studies (>500), it took several minutes to search for the correct study.
During the initial case entry, when the user is searching for a study in a Project containing large number of studies, the system returns the results much faster than before.
In the Case Routing dialog, when there were no available states to route to, the route to user displayed Any, instead of the assigned-to user.
In the Case Routing dialog, when there no available states to route to, the route to user displays the assigned user.
Follow these steps to download the patch from My Oracle Support (MOS):
Open an MOS (https://support.oracle.com) session in a browser.
Click the Patches & Updates link.
Enter 13869833 into the Patch ID field.
Click Download and save the compressed file to a temporary location on your local system.
Locate the downloaded file and extract it to a temporary directory. The file contains the Release Notes (readme_argus701.html), the Oracle Argus Safety 7.0.1 Installation Guide, and the Argus Safety 7.0.1 Installer.
For detailed instructions on how to install Oracle Argus Safety, please see the Oracle Argus Safety Installation Guide.
Refer to the following documents for the Argus Safety 7.0.1 release, which are available on the Oracle Technology Network (OTN) website (http://www.oracle.com/technetwork/index.html):
Oracle Argus Safety Dossier User's Guide (E26220-01)
Oracle Argus Safety Installation Guide (E26221-01)
Oracle Argus Safety User's Guide (E26223-01)
Oracle Argus Safety Administrator's Guide (E26224-01)
Oracle Argus SafetyInterchange User's Guide (E26627-01)
Oracle Argus Safety Unblinding User's Guide (E26628-01)
Oracle Argus Affiliate User's Guide (E26629-01)
Oracle Argus Safety Service Administrator's Guide (E26630-01)
Please refer to the Oracle Argus Safety 7.0.1 Installation Guide for more detailed installation instructions and for information about the technology stack, which is included in p13869833_70_WINNT.zip.
Apply this patch to the following components of an Oracle Argus Safety installation:
Argus Safety Web / Report Server
Argus Safety Transaction Server
Argus Safety Database Server
Argus Safety 7.0.1 provides a fresh installation of the Argus Safety application, if you do not have a previous Argus Safety application installed on your system. Please use the following installation steps:
Log in to the computer (or application server) as an administrator.
Run the setup.exe program: From the folder where the Argus Safety 7.0.1 Installer is extracted, run the setup.exe program. From the main screen, select Argus Safety and follow the setup steps.
Restart the computer.
The Argus Safety 7.0.1 application installation program can automatically update systems running any lower version of 7.0.x . All servers where applications are installed must be updated. During the update, the installer preserves the following Argus Configuration Files:
Caution:Please back up the following configuration files before proceeding with this application upgrade. All system configuration (.config) files will be overwritten by this upgrade and your manual configuration changes will be lost. These files may be stored on multiple servers, depending on components selected at the time of the Argus installation (web server, report server, integration server, transaction server, and so on). The directory structure of the file, however, remains constant. Refer to the following list of commonly modified configuration files:
.\ArgusWeb\ASP\Argus.NET\bin\Intake.config.\ArgusWeb\ASP\Argus.NET\bin\RelsysWindowsService.exe.config.\ArgusWeb\ASP\Argus.NET\bin\Service.config.\ArgusWeb\ASP\Argus.NET\web.config.\ArgusWeb\ASP\ArgusConsole\web.config.\ArgusWeb\ASP\Integrations\Service.config.\ArgusWeb\ASP\Integrations\Web.config.\ArgusWeb\ASP\web.config.\ArgusWeb\Bin\Argusvr2.config.\ArgusWeb\Bin\Argusvr2a.config.\Argus Safety\AGProc.config.\Argus Safety\Intake.config.\Argus Safety\RelsysWindowsService.exe.config.\Argus Safety\Service.config.\DBInstaller\ArgusDBInstall.exe.config.\ESMMapping\ESMapping.exe.config
Use the following steps to upgrade the Argus Safety application:
Log in to the computer as an administrator.
Stop all server processes to ensure there are no users running Argus Safety.
Run the setup.exe program. The setup application verifies that Argus Safety 6.0 or higher is installed. If setup detects an unsupported version, you will be prompted to uninstall before proceeding.
Update the application: The setup application automatically updates the necessary application files to complete the installation.
Restart the computer.
The Argus Safety 6.0.1 or 18.104.22.168 or 7.0 or 22.214.171.124 Database is required before performing the database upgrade. See the Oracle Argus Safety 7.0.1 Installation Guide for detailed installation instructions.
If using DLP, ensure that the EXECUTE grant is given to the DBA privileged user account that is performing the DLP upgrade. To provide this grant, login with the SYS user account and execute the following statement:
GRANT EXECUTE ON SYS.DBMS_LOCK TO < dba_privileged_user > WITH GRANT OPTION;
Install the Argus 7.0.1 Database Schema Creation Tool.
Before upgrading to the 701 database, validate the existing Argus Safety 6.0.1 or 126.96.36.199 or 7.0 Database by using the Schema Validation file VLDN_601.CTL or VLDN_6011.CTLorVLDN_70.CTL (respectively) in C:\Program Files\Oracle\DBInstaller\SchemaValidation.
From Windows, click Start > Programs > Oracle > Schema Creation Tool > DB Upgrade.
Select the following folder, when prompted: ORACLE > DBInstaller > Upgrades > UPGRADE_TO_701.
Follow the prompts on the screen.
Review the Upgrade log file upon completion.
After the upgrade to the 701 database is complete, validate the schema using the Schema Validation file VLDN_701.CTL in C:\Program Files\Oracle\DBInstaller\SchemaValidation.
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Oracle Argus Safety, Release 7.0.1
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