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Oracle® Argus Safety Release Notes
Release 7.0.1

Part Number E26222-01
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Oracle® Argus Safety

Release Notes

Release 7.0.1

E26222-01

March 2012

Overview

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.



Priority: High
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
Patches Obsoleted: None
Version: This is the first version.
Prerequisites: Argus Safety 7.0
Platforms: All

Supported Environments

The following is certified in this release, in addition to the base environment specified for Argus Safety 7.0 and 7.0.0.1:

  1. Windows Server 2008 R2 64 bit for all Argus Safety components installed on the following boxes:

    1. Web/Report Server

    2. Transaction Server

  2. Oracle Enterprise Linux 6.1 UEK for Database server

  3. IIS 7.5 on Windows Server 2008 R2 64 bit for Argus Safety Web / Report Server

  4. Axway Interchange (Cyclone) version 5.10

  5. Oracle Database 11.2.0.1 (Enterprise/Standard) and 11.2.0.3 - AL32UTF8 character set for Database server

  6. Oracle Virtual Machine 2.2.2

  7. Internet Explorer 9.0 browser

  8. 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.

Features Implemented

This section describes the new features introduced in Oracle Argus Safety 7.0.1.

Case Processing Time for Analytics

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)

Updated MedWatch Evaluation Codes

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.

Argus Global Application for Argus Safety Web

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.

Installer Changes

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.

Global Admin Role

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.

User Assignment for Unassigned Cases

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

DSUR

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.

Configuring Development International Birth Date (DIBD)

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.

MedDRA Web Service Integration Enhancement

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

PMDA E2B Import for Research Reporting Categories

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 Enhancement

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.

Case Form Attachments

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

Attachment Classification Filter in Worklist New and Open

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 Performance Enhancements

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.

MedDRA Recoding with DLP Enabled

For optimal performance of MedDRA recode on DLP Enabled safety database, please follow the steps outlined below:

  1. Connect as dlp_stage in Argus Safety database and disable trigger t_scase_master_count.

    ALTER TRIGGER t_scase_master_count DISABLE;
    
  2. 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;
    
  3. Start the Recode Tool. Perform the desired operations.

  4. Enable the trigger that was disabled in step 1.

    ALTER TRIGGER t_scase_master_count ENABLE;
    
  5. 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;
    

Japanese E2B Import

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.

Research Report Data Entry Usability Enhancement

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.

Case Form Text Data Copy

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

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.

Event Reportability Rule Enhancement

When an E2B is generated for the PMDA, only reportable events are transmitted. Selection between the event level and case level seriousness for the event reportable matrix is now configurable using Common Profile Switch.

Issues addressed in the Argus Safety 7.0.1 Patch

This section describes the bugs fixed in this patch. For details regarding a specific bug, please see the Bug Database.

7.0.1 Patch Scope Issues

Bug Description
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

Bug 10173408

Before

Case Deletion Nullification Acknowledgement Print was not showing errors/warnings.

After

Case Deletion Nullification Acknowledgement Print is showing errors/warnings.

Modules Affected

Submitted Reports

Bug 12432372

Before

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.

After

The system does not round off the values entered for Time (Day) Norm and Time (Day) Max Workflow rules paramaeters in the Workflow configuration .

Modules Affected

Argus Console - Workflow Configuration

Bug 11844183

Before

Argus Insight did not open from Argus Safety URL, when the user had access to Argus Insight and the default application was Argus Insight.

After

User can access Argus Insight from the Argus Safety URL.

Modules Affected

Login

Bug 10132424

Before

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.

After

Users are able to print the Case Data Analysis (CDA) report using the chart option consistently, without any problems.

Modules Affected

Case Data Analysis Reports

Bug 11853794

Before

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.

After

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.

Modules Affected

E2B

Bug 12325558

Before

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

After running batch case close process of EOSU, Case is in Closed state.

Modules Affected

End of Study Unblinding (EOSU)

Bug 12685697

Before

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.

After

E2B import process creates the case with same number of study products as specified in the study configuration.

Modules Affected

E2B

Bug 12822555

Before

Accepting EMA report from E2B Pending screen failed when senderdiagnosis had data.

After

The EMA report with senderdiagnosis data is successfully imported from E2B Pending screen .

Modules Affected

E2B

Bug 12938203

Before

Unprocessed files from New Case from Image were restored by adding an extra "." along with original file name.

After

Unprocessed files are restored with the original name in Case Actions > New Case from Image.

Modules Affected

Case Actions

Bug 12950660

Before

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.

After

The system saves the settings for Dictionaries in Common Profile Switch without any error.

Modules Affected

Argus Console > System Configuration > Common Profile Switch

Bug 12945766

Before

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.

After

The MedDRA tables listed above are getting exported and imported into the Target database.

Modules Affected

Database

Bug 13010165

Before

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.

After

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.

Modules Affected

Periodic Reports

Bug 13011839

Before

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.

After

When periodic reports are run on DLP, child expedited reports are also generated on DLP.

Modules Affected

Periodic Reports

Bug 12677909

Before

The CIOMS-II Line Listing Report was taking more time than what was committed in the SLA.

After

The CIOMS-II Line Listing Report is generated within the time committed in the SLA.

Modules Affected

CIOMS Line Listing Reports

Bug 12998939

Before

The MedDRA browser was displaying the incorrect coded version on clicking the Encode button from Patient > Lab Data.

After

The MedDRA browser is displaying the correct coded version on clicking the Encode button from Patient > Lab Data.

Modules Affected

MedDRA

Bug 13073075

Before

The AG Service user was not getting updated through the default enterprise, if the user had a different User ID in different enterprises.

After

The AG Service user is updated through the default enterprise if the user has a different User ID in different enterprises.

Modules Affected

AG Service

Bug 13033115

Before

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.

After

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.

Modules Affected

Login

Bug 13421210

Before

On entering incorrect date in LAM | Event Information | Onset date field, a VB Script runtime error appeared.

After

On entering incorrect date in LAM | Event Information | Onset date field, the VB Script runtime error does not appear.

Modules Affected

Case Form

Bug 13404662

Before

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.

After

The MedDRA recode from 14.0 to 14.1 updates the hierarchy/terms and the dictionary version to match 14.1.

Modules Affected

MedDRA

Bug 13404521

Before

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.

After

ESM Service processes the incoming E2B file only once.

Modules Affected

Argus Interchange

Bug 13373057

Before

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.

After

All the Historical Drugs entered in the Other Relevant History are printed in Box 23 of the CIOMS-I report.

Modules Affected

Expedited Reports

Bug 13104024

Before

When the Print All option was selected for the User Configuration Report, multiple entries per site were shown under Site Security for all users.

After

When the Print All option is selected for the User Configuration Report, a single entry per site is shown under Site Security.

Modules Affected

Argus Console

Bug 13100343

Before

Argus was generating a narrative with invalid characters when using an apostrophe (') in the narrative phrase.

After

Unicode characters are displayed properly on the Case Form-Auto Narrative and Abbreviated Narrative.

Modules Affected

Case Form

Bug 12963304

Before

Users were unable to capture the duration of Hospitalization on the Events tab, unless they had specific Start and Stop Dates for hospitalization.

After

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.

Modules Affected

Case Form

Bug 12682104

Before

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.

After

Records created while generating the preview E2B draft get deleted when the user closes the report.

Modules Affected

E2B

Bug 12676752

Before

When the user entered data in any field and clicked the Save button without tabbing out to another field, the data was not saved.

After

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.

Modules Affected

Case Actions

Bug 13467442

Before

Shift-JIS encoded PMDA E2B files and UTF-16 encoded Non-PMDA E2B files were not imported by Interchange Service.

After

Shift-JIS encoded PMDA E2B files and UTF-16 encoded Non-PMDA E2B files are now imported by Interchange Service.

Modules Affected

E2B

Bug 13586801

Before

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.

After

Retransmission can be done for failed E2B report from Bulk E2B Transmit screen using preferred route as Fax.

Modules Affected

E2B

Bug 13620217

Before

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

After

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

Modules Affected

Worklist

Bug 13644009

Before

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 .

After

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.

Modules Affected

Case Form

Bug 13632004

Before

The Reporter Salutation placeholder did not display data in Affiliate Letters.

After

The Reporter Salutation placeholder displays data in Affiliate Letters.

Modules Affected

Case Form

Bug 13626527

Before

Legacy cases that had no patient information could throw an error while attempting to print Patient information.

After

Legacy cases that have no patient information no longer throws an error while printing Patient information.

Modules Affected

Case Actions

Bug 13555332

Before

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.

After

The application saves the Start Date in only the Start date field for the Vaccine products in the database.

Modules Affected

Case Form

Bug 13556605

Before

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.

After

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.

Modules Affected

Periodic Reports - NDA

Bug 11828499

Before

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.

After

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.

Modules Affected

Case Form

Bug 13768715

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.

After

In the Case Routing dialog, when there no available states to route to, the route to user displays the assigned user.

Modules Affected

Case Form

Bug 13681659

Before

The user was able to add more than (1500) the allowed number of lab test records.

After

The user cannot add more than (1500) the allowed number of lab test records.

Modules Affected

Case Form

Downloading the Patch

Follow these steps to download the patch from My Oracle Support (MOS):

  1. Open an MOS (https://support.oracle.com) session in a browser.

  2. Click the Patches & Updates link.

  3. Enter 13869833 into the Patch ID field.

  4. Click Search.

  5. Click Download and save the compressed file to a temporary location on your local system.

  6. 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.

Installing the Patch

For detailed instructions on how to install Oracle Argus Safety, please see the Oracle Argus Safety Installation Guide.

References

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

Application Installation

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:

  1. Log in to the computer (or application server) as an administrator.

  2. 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.

  3. Restart the computer.

Application Upgrade

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:

  • Argus.ini

  • Agservice.ini

  • Argus.xml

  • ESMService.ini

  • ESMMapping.ini

  • E2BViewer.ini

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:

  1. Log in to the computer as an administrator.

  2. Stop all server processes to ensure there are no users running Argus Safety.

  3. 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.

  4. Update the application: The setup application automatically updates the necessary application files to complete the installation.

  5. Restart the computer.

Database Update

The Argus Safety 6.0.1 or 6.0.1.1 or 7.0 or 7.0.0.1 Database is required before performing the database upgrade. See the Oracle Argus Safety 7.0.1 Installation Guide for detailed installation instructions.

  1. 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; 
    
  2. Install the Argus 7.0.1 Database Schema Creation Tool.

  3. Before upgrading to the 701 database, validate the existing Argus Safety 6.0.1 or 6.0.1.1 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.

  4. From Windows, click Start > Programs > Oracle > Schema Creation Tool > DB Upgrade.

  5. Select the following folder, when prompted: ORACLE > DBInstaller > Upgrades > UPGRADE_TO_701.

  6. Follow the prompts on the screen.

  7. Review the Upgrade log file upon completion.

  8. 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.

Documentation Accessibility

For information about Oracle's commitment to accessibility, visit the Oracle Accessibility Program website at http://www.oracle.com/pls/topic/lookup?ctx=acc&id=docacc.

Access to Oracle Support

Oracle customers have access to electronic support through My Oracle Support. For information, visit http://www.oracle.com/pls/topic/lookup?ctx=acc&id=info or visit http://www.oracle.com/pls/topic/lookup?ctx=acc&id=trs if you are hearing impaired.


Oracle Argus Safety, Release 7.0.1

E26222-01

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