Oracle Argus

Release Notes – What’s New

Release 8.2
E96166-01
August 2018

1 Contents
■ Technology Stack
■ Oracle Argus Compatibility Matrix
■ Enhancements to Argus Safety
■ Enhancements to Argus Safety Japan
■ Merged Patches
■ Download Oracle Argus 8.2
■ Install Oracle Argus 8.2
■ Upgrade Oracle Argus Database
■ Product Documentation
■ Updated Argus Safety User's Guide
■ Argus 8.2 eTRMs (Bugs 26862322, 26898568, 26898513, and 26898732)
■ Documentation Accessibility

2 Technology Stack

2.1 New components introduced in Argus 8.2

Argus Safety supports the latest technology stack currency thereby reducing the risk of
security vulnerabilities. The following components have been added:
■ Oracle Database 12.2.0.1
■ Fusion Middleware 12.2.1.3 (excluding OBI)
■ OBI 12.2.1.4
■ IDM 11.1.2.3
■ MS Windows 2016
■ AxWay B2Bi 2.3.1 SP1

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The following table provides the new list of the Oracle Argus 8.2 technology stack
components.

Server Components Versions

Oracle Database Database 12.2.0.1
12.1.0.2
Web and Transaction OS Windows 2016
Servers
Windows 2012 R2
DB Client 12.2.0.1
12.1.0.2
Documentum DFC 7.2 (32 Bit)
RightFax 10.6 (32 Bit)
Reporting Servers OBIEE 12.2.1.4
BIP (Standalone)
ETL ODI 12.2.1.3
EDI Gateway Oracle B2B 12.2.1.3
AxWay B2Bi 2.3.1 SP1
Client OS Windows 10
Browser IE 11 (32/64 bit)
Compatibility
Mode
MS Office Any version
Adobe DC
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2.2 Components discontinued from Argus 8.2

■ The following components have been deprecated from the technology stack:
- Fusion Middleware 12.2.1.0
- AxWay Gateway Interchange 5.12
■ Virtual directories that were used for PDF reports, scanned images, and uploaded
letters have been discontinued.
■ The New Case from Image option is no longer available. Oracle recommends using
the Worklist Intake or Literature Intake option.
■ The MS Visual Basic Power Packs 10.0 is no longer a prerequisite for Argus Safety.
The various dictionary loaders used the Power Pack components to move or hide
different options for Overwrite Existing Reports and Add New options in the
Argus application.
■ BCL EasyPDF has been completely discontinued (including the Dossier
bookmark).
■ Informatica, Cognos, and SAP BusinessObjects are no longer supported in Argus
Insight, Mart, and Analytics.

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3 Oracle Argus Compatibility Matrix
The following table lists the compatibility of this release with Argus Insight, Mart, and
Analytics.

Argus Analytics Argus Analytics 8.2

Argus Insight Argus Insight 8.2
Argus Mart Argus Mart 8.2

Go to Contents

4 Enhancements to Argus Safety

4.1 64-bit support

The application has been upgraded to provide 64-bit support. This allows it to utilize
memory more effectively and accommodate more concurrent usage. It also allows very
large installations of Argus without facing sequence number limitation. Further, the
overall middle tier server footprint is reduced thereby reducing the overall operational
cost. No end user functionality or business logic change has been made.

Note: All third-party integrations have been updated to 64-bit except

RightFax and Documentum which continue to support 32-bit.

Go to Enhancements to Argus Safety

4.2 Global Names parameter update

Oracle Argus uses a number of database links for transferring data between different
databases. The database link names were arbitrary without any forced naming
convention. From this release onwards, you can set the Global Names parameter to
TRUE forcing the database links to follow the database schema names. This change is
optional.
Go to Enhancements to Argus Safety

4.3 Virtual directory removal

Argus used virtual directories for PDF reports, scanned images and uploaded letters
for storing the report attachments, lab data, and so on. These virtual directories have
been removed and are now maintained via the Argus.ini configuration file.
With this change, the feature New Case from Image has been deprecated. Oracle
recommends using the Worklist Intake or Literature Intake option. The Argus Console
will no longer have the profile switch Case Processing > Default Network directory
for scanned images. Additionally, caching of the case is allowed only at the database
level and caching at file level is unsupported.
Go to Enhancements to Argus Safety

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4.4 Separate proxy settings for ESM and SMTPS
Previously, Argus servers did not have a direct connection in Cloud. As a result, Argus
used a single proxy configuration for both ESM (for Argus Interchange DTD URL
validation) and SMTPS.
Now, Argus uses separate proxy settings for ESM and SMTPS. A direct port was
opened in the Cloud on the Firewall for SMTPS.
A new Use Proxy settings for SMTP/S common profile switch is available to enable or
disable proxy use for establishing the SMTPS connection. The default state of the Use
Proxy settings for SMTP/S profile switch is to not use the proxy configuration to
match Cloud settings.
Go to Enhancements to Argus Safety

4.5 Date format to support milliseconds in (R3) ACK, ICSR (Bug 27603117)
On submitting E2B (R3) reports, EMA sends out the date/time with millisecond data
for some data elements in the Acknowledgment (ACK). Millisecond data can also be
part of ICSR reports.
On importing the ICSR/ACK file with millisecond data, the system failed to import
the file, and an error was displayed in the import log file.
The system has been enhanced to ignore the millisecond part of date/time for
elements in EMA E2B (R3) and PMDA E2B (R3) profiles while importing ICSR and
acknowledgments.
ACK
■ MESSAGEDATER3 (ACK.M.4) - Acknowledgement Date of Batch Transmission
■ REPORTMESSAGEDATE (ACK.B.r.5) - Date of ICSR Message Creation
■ ICSRMESSAGEDATER3 (ACK.A.3) - Date of ICSR Batch Transmission
ICSR
■ BATCHMESSAGEDATE (N.1.5) - Date of Batch Transmission
■ MESSAGECREATIONDATE (N.2.r.4) - Date of Message Creation
■ TRANSMISSIONDATER3 (C.1.2) - Date of Creation
Go to Enhancements to Argus Safety

4.6 What’s New in Argus 8.2 video available on Oracle Argus OHC page
A What’s New video is now available on the Argus Oracle Help Center (OHC) page for
an overview of the enhancements in the latest release of Oracle Argus. You can access
the video using this link:
https://apexapps.oracle.com/pls/apex/f?p=44785:265:0::::P265_CONTENT_
ID:24035

4.7 Missing UCUM codes in eVAERS (Bug 27361718)

The application has been enhanced with the following list of supported codes:
■ New codes have been added to the Flexible codelist for DOSE_UNITS,
STRENGTH_UNITS, and LAB_TEST_UNITS.

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■ The list of allowed values for the following data elements of the eVAERS profile
have been updated:
- TESTUNIT (F.r.3.3)
- DRUGCUMULATIVEDOSAGEUNITR3 (G.k.5b)
- STRENGTHUNIT (G.k.2.3.r.3b)
- DRUGSTRUCTUREDOSAGEUNIT (G.k.4.r.1b)
- DRUGINTERVALDOSAGEDEFINITION (G.k.4.r.3)
- GESTATIONPERIODUNITR3 (D.2.2.1b)
- REACTIONGESTATIONPERIODUNITR3 (G.k.6b)
- PARENTAGEUNITR3 (D.10.2.2b)
- Patient and Parent age at the time of vaccination (regional elements such as
PATIENTAGEATVACCINATIONUNIT, PASTVACCINEAGEONSETUNIT,
PARENTAGEATVACCINATIONUNIT)
■ UCUM codes for decade have been hardcoded as {decade} in eVAERS, and the
UCUM code from the flexible codelist is not considered for the following Decade
data elements:
- PATIENTONSETAGEUNITR3 (D.2.2b)
- PATIENTAGEATVACCINATIONUNIT
- PASTVACCINEAGEONSETUNIT
- PARENTAGEATVACCINATIONUNIT
- PARENTAGEUNITR3 (D.10.2.2b)
For more details, refer to the Codelist Data sheet in CaseForm Console Updates
Summary.xls, and the Appendix for eVAERS sheet of the E2B (R2) Export Mappings.xlsx.
Go to Enhancements to Argus Safety

4.8 SPANISH_STATE code list missing values (Bug 27111633)

The SPANISH_STATES Flexible codelist has been enhanced to include the CEUTA and
MELILLA values. These will be included in the list of allowed values for the data
elements in the EMA E2B (R2) and (R3) profiles.
E2B (R2) export and import logic has been updated for REPORTERSTATE (A.2.1.2e)
data element, when the Reporter's country is Spain.
■ E2B (R2) export mapping has been updated to use the text entered in Reporter's
State field to derive codes from the SPANISH_STATES codelist.
■ E2B (R2) import mapping has been updated for the REPORTERSTATE (A.2.1.2e)
data element such that State code entered in data element REPORTERSTATE
(A.2.1.2e) is used to derive the State Name text from the SPANISH_STATES
codelist.
For more details, refer to the following documents:
■ Codelist Data sheet in CaseForm Console Updates Summary.xls
■ EMA_Appendix and the E2BR3_Mappings sheets of the E2B (R3) Export
Mappings.xlsx

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■ Appendix for EMA and E2BR2 Export sheets of the E2B (R2) Export Mappings.xlsx
■ E2BR2_Import sheet of the E2B (R2) Import Mappings.xlsx
Go to Enhancements to Argus Safety

4.9 Inclusion of missing countries in the Country codelist (Bug 14001186)

The application has been enhanced to include the following countries, along with the
A2, A3, and numeric codes, in the Country codelist:
■ Bonaire, Sint Eustatius, and Saba
■ Curaçao
■ South Sudan
■ Sint Martin (Dutch part)
The newly added A2 country codes are included in the list of allowed values for the
following data elements in the ICH E2B (R3), EMA E2B (R3), eVAERS, and PMDA E2B
(R3) profiles respectively.
■ REPORTERCOUNTRYR3 (C.2.r.3)
■ SENDERCOUNTRYCODE (C.3.4.5)
■ STUDYREGCOUNTRY (C.5.1.r.2)
■ REACTIONOCCURCOUNTRY (E.i.9)
■ OBTAINDRUGCOUNTRY (G.k.2.4)
■ DRUGAUTHORIZATIONCOUNTRY (G.k.3.2)
■ VACCFACILITYCOUNTRY (Regional Data element for eVAERS)
■ PATIENTCOUNTRYCODE (Regional Data element for eVAERS)
The newly added A2 country codes are included in the list of allowed values for the
data elements in ICH E2B (R2), EMA E2B (R2), FDA E2B (R2), and PMDA E2B (R2)
profiles.
■ PRIMARYSOURCECOUNTRY (A.1.1)
■ OCCURCOUNTRY (A.1.2)
■ REPORTERCOUNTRY (A.2.1.3)
■ SENDERCOUNTRYCODE (A.3.1.4e)
■ RECEIVERCOUNTRYCODE (A.3.2.3e)
■ OBTAINDRUGCOUNTRY (B.4.k.2.3)
■ DRUGAUTHORIZATIONCOUNTRY (B.4.k.4.2)
The newly added A3 country codes are included in the list of allowed values for the
data elements in eMDR profile.
■ MFRCOUNTRY (D3)
■ REPROCCOUNTRY (D9)
■ REPORTERCOUNTRYR3 (E1)
■ UFCOUNTRY (F3)
■ FMFRCOUNTRY (F14)

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■ MFRCONTACTCOUNTRYCODE (G1)
For more details, refer to the Codelist Data sheet in CaseForm Console Updates
Summary.xls.
Go to Enhancements to Argus Safety

4.10 Additional values for Vaccination Facility type (Bug 27550256)

The application has been enhanced such that the NCI codes pertaining to the
following values in the VACCINATED_AT Flexible codelist are considered as allowed
values for the VACCAT data element in the eVAERS profile.
■ Pharmacy/drug store
■ Nursing home
■ Long-term care for elderly
For more details, refer to the eVAERS sheet in the E2B (R3) Export Mappings.xlsx.
Go to Enhancements to Argus Safety

4.11 Additional Null Flavor for Vaccine Anatomical Approach Site (Bug
27400075)
The UNK, ASKU, and NI null flavors have been provided for the
VACCANATOMICALSITE data element in the eVAERS profile. To ensure that these
values can be used for the eVAERS profile, these values have been included in the
Anatomical Location codelist.
For more details, refer to the Codelist Data sheet in CaseForm Console Updates
Summary.xls and the E2BR3_Mappings sheet of the E2B (R3) Export Mappings.xlsx.
Go to Enhancements to Argus Safety

4.12 EMA E2B (R3) regulatory guideline updates (March 2018) - Null flavor
changes (Bug 27729305)
EMA revised the business rules sheet for E2B (R3) in March 2018 to include UNK null
flavor support for the PATIENTDRUGNAME (D.8.r.1) data element. Accordingly, the
import and export mappings of the element have been updated to send null flavor
data if UNK is selected from the Null Flavor drop-down list.
For more details, refer to the E2BR3_Mappings sheet of the E2B (R3) Export
Mappings.xlsx.
Go to Enhancements to Argus Safety

4.13 Transmit gestation period for the Neonate age group (Bug 27690800)
As per current mapping logic in EMA E2B (R3), the system transmits
GESTATIONPERIOD (D.2.2.1a) and GESTATIONPERIODUNITR3 (D.2.2.1b) only if
the age group is foetus. As per inputs received from EMA, the application has been
enhanced to transmit gestation period and unit when the age group is neonate or
foetus.

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For more details, refer to the E2BR3_Mappings sheet of the E2B (R3) Export
Mappings.xlsx and the PMDA Mapping sheet of the PMDA E2B (R3) Export Import
Mappings.xlsx.
Go to Enhancements to Argus Safety

4.14 Import of master case ICSR files supported (Bug 27363341)

When submitting a Safety Message to EV, the values accepted in the data element
BATCHMESSAGETYPE (N.1.1) can be one of the following:
■ Ichicsr
■ Backlog
■ Master
■ Recoded
■ Master recoded
The application has been enhanced to support the import of EMA (R3) files having
these values in BATCHMESSAGETYPE (N.1.1).
Based on the EMA (R3) IG section I.C.3.1.1 Message Type, EMA (R3) import has been
enhanced to support the following N.1.1 BATCHMESSAGETYPE (N.1.1) values:
■ code = 1, Term = ichicsr, OID = 2.16.840.1.113883.3.989.2.1.1.1
■ code = 1, Term = backlog, OID = 2.16.840.1.113883.3.989.5.1.1.5.1
■ code = 2, Term = master, OID = 2.16.840.1.113883.3.989.5.1.1.5.1
■ code = 3, Term = recoded, OID = 2.16.840.1.113883.3.989.5.1.1.5.1
■ code = 4, Term = master recoded, OID = 2.16.840.1.113883.3.989.5.1.1.5.1
For the updated import mapping logic of BATCHMESSAGETYPE (N.1.1) element,
refer to the E2B (R3) Import Mappings.xlsx.
Go to Enhancements to Argus Safety

4.15 Normal low and high range to be numeric values only (Bugs 27564255,
27681138)
The application has been enhanced to support transmission of only numeric data for
the LOWTESTRANGE (F.r.4) and HIGHTESTRANGE (F.r.5) elements. Validations are
triggered if the user enters any non-numeric character and tries to generate the E2B
(R3) report.
The support for numeric data type is applicable for all (R3) profiles - ICH, EMA,
eVAERS, and PMDA.
For more details, refer to the ICH_Validations, eVAERS_Validations, and EMA_
Validations sheets in the E2B (R3) Export Mappings.xlsx, and the Validations sheet in the
PMDA E2B (R3) Export Import Mappings.xlsx.
Go to Enhancements to Argus Safety

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4.16 Removal of line breaks within encoded attachment data (Bug
28027853)
As EudraVigilance’s XCOMP does not support line breaks in Base64 encoded data,
ICSRs sent with attachments to EMA were not receiving Acknowledgements. A new
common profile switch, Enable stripping of line breaks in attachment data for EMA E2B(R3)
profile, has been provided in Reporting > E2B node.
When this parameter is set to Yes (default), the system removes line breaks in encoded
attachment data from the EMA E2B (R3) ICSR. When set to No, the system retains line
break characters in the encoded attachment data.
Go to Enhancements to Argus Safety

4.17 eMDR: Update device problem codes used for F10 and H6 as per the
new DPC hierarchy (Bug 27577310)
CDRH published the upcoming eMDR system enhancements on 11 December, 2017,
with the list of FDA adverse event codes to be used in F10 and H6 in order to be
harmonized with the IMDRF Adverse Event Reporting terminology.
The application has been enhanced to provide these (required by April 2018).
The system does not allow inactive codes to be sent in the eMDR report.
Factory data has been updated for Patient, Device, Evaluation Method, Results, and
Conclusion codes so that all new codes introduced in the CDRH guidelines have been
provided in the CFG_MEDWATCH_CODES table.
■ FDADEVICECODES, FDAPATIENTCODES (F10)
■ MFRDEVICECODE, MFRPATIENTCODE (H6)
■ EVALCODEMETHOD (H6)
■ EVALCODERESULT (H6)
■ EVALCODECONCLUSION(H6)
For more details on the list of allowed values in the eMDR profile, refer to the Device
Codes sheet in the eMDR Export Mappings.xlsx.
Go to Enhancements to Argus Safety

4.18 Allowed values to be enhanced for E2B (R3) data elements for the
EMA profile (Bug 27897642)
The list of allowed values for the following E2B (R3) data elements have been
enhanced to comply with EMA (R3) regulations.
■ CONCOMTHERAPY (D.7.3)
■ FAMILYHISTORY (D.7.1.r.6)
■ DUPLICATER3 (C.1.9.1)
■ SERIOUSNESSDEATH (E.i.3.2a)
■ SERIOUSNESSLIFETHREATENING (E.i.3.2b)
■ SERIOUSNESSHOSPITALIZATION (E.i.3.2c)
■ SERIOUSNESSDISABLING (E.i.3.2d)

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■ SERIOUSNESSCONGENITALANOMALI (E.i.3.2e)
■ SERIOUSNESSOTHER (E.i.3.2f)
■ DRUGSTARTPERIODUNIT (G.k.9.i.3.1b)
■ DRUGLASTPERIODUNIT (G.k.9.i.3.2b)
■ PATIENTONSETAGEUNITR3 D.2.2b
■ PARENTAGEUNITR3 (D.10.2. 2b)
■ TESTUNIT (F.r.3.3)
■ PATIENTDRUGSUBSTANCESTRUNIT (D.8.r.EU.r.3b)
■ PARENTDRUGSUBSTANCESTRUNIT (D.10.8.r.EU.r.3b))
■ STRENGTHUNIT (G.k.2.3.r.3b)
■ DRUGSTRUCTUREDOSAGEUNIT (G.k.4.r.1b)
■ DRUGCUMULATIVEDOSAGEUNITR3 (G.k.5b)
For more details, refer to the Appendix for EMA sheet in the E2B (R3) Export
Mappings.xlsx.
Go to Enhancements to Argus Safety or Contents

5 Enhancements to Argus Safety Japan

5.1 Conformance updates according to PMDA E2B (R3) reporting category

(Bug 27079397)
Reporting category conformance for the PMDA E2B (R3) profile has been corrected for
the following elements based on Data element list published by the PMDA:

PATIENTSEXR3 (D.5) Conformance has been updated as RN for the AA, AB, AC,
AD, DA, DB, DC, and DD categories. Validation for D.1
Patient Initials has been updated to include the element
D.5[PATIENTSEXR3] in the condition for at least one Patient
data to be entered.
DRUGBATCHNUMB Conformance has been updated as M for the DA category.
(G.k.4.r.7)

For more details, refer to the PMDA Mapping sheet and Validations sheet in the PMDA
E2B (R3) Export Import Mappings.xlsx
Go to Contents

6 Merged Patches
The bug fixes from the following patches are merged with Argus 8.2:
■ 8.1.2.2
■ 8.1.2.1
■ 8.1.2

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■ 8.0.0.1.1
■ 7.0.7.5
Go to Contents

7 Download Oracle Argus 8.2

Execute the following steps to download the patch from Oracle Software Delivery
Cloud (OSDC):
1. Log in to OSDC (https://edelivery.oracle.com) using your credentials.
2. Select All from the Search by drop-down list.
3. Enter Oracle Argus Standard Edition or Oracle Argus Enterprise Edition, as applicable.
4. Click Select Platform to choose the relevant platform and click Select.
5. Click Continue to add to your download queue.
6. On the Download Queue page, select the relevant release and click Continue to
download.
Go to Contents

8 Install Oracle Argus 8.2

The application does not support an in-place upgrade from any previous versions.
Only a fresh application is supported.
For detailed instructions on how to install the various Oracle Argus products, see their
respective installation guides.
Go to Contents

9 Upgrade Oracle Argus Database

See respective Oracle Argus products installation guide for this release.

9.1 Upgrade Argus Safety from 8.1, 8.1.1, or 8.1.2 to 8.2

See the Oracle Argus Safety 8.2 Installation Guide.

9.2 Upgrade Argus Safety from 8.0.0.x to 8.1

1. From Argus 8.0 Schema Creation Tool, validate the Argus Safety and DLP Schema
(if DLP is currently installed), using the file VLDN_80.CTL located at
.\Oracle\Argus\DBInstaller\SchemaValidation.
2. Verify the validation log file and make sure that there are no errors, missing and
invalid objects.
3. Install the recommended Java version on the server from where the following
steps will be executed.
Refer to the Oracle Argus Safety 8. 2 Installation Guide, Section 1.2.2 Oracle
Components.

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4. From .\Argus Safety 8.2\Previous Database Upgrades, copy the folder 80-81
Upgrade and paste on the server where Oracle Client is installed.
5. From the 80-81 Upgrade folder, update the dbinstaller.properties file:
a. ArgusSecurekey location.
b. TDE attribute (if required) with the required connection details.
c. All the user details present in the properties file.
d. Parameters as specified for the Argus Safety Database setup. For more details,
refer to the Oracle Argus Safety 8. 2 Installation Guide, Section 12.2 Argus Safety
Database Upgrade.
6. To upgrade Argus Safety from the user interface, go to the 80-81 Upgrade folder,
open the command prompt, and run the dbinstallerUI.bat file as an administrator.
For more details to upgrade from the user interface and for silent upgrade (using
the dbinstaller.bat file), refer to the Oracle Argus Safety 8. 2 Installation Guide,
Section 12.2 Argus Safety Database Upgrade.
7. Upgrade Argus Safety from 8.1, 8.1.1, or 8.1.2 to 8.2.
8. From the 8.2 Schema Creation Tool, validate the Argus Safety and DLP Schema,
using the VLDN_82.CTL file located at:
.\Oracle\Argus\DBInstaller\SchemaValidation.
9. Verify the validation log file and make sure that there are no errors, missing and
invalid objects. Ignore any extra objects in validation due to dlp_case_rev_master_
bkp and tmp_dcrm_upd_data, these objects are related to dlp_case_rev_master
correction script.

10 Product Documentation
The most current documentation set, excluding the Release Notes, is available at the
following location:
https://docs.oracle.com/en/industries/health-sciences/index.html
Go to Contents

11 Updated Argus Safety User's Guide

To ensure that you have access to the most updated and relevant information, we have
made the following additional changes to the Argus Safety User's Guide:
■ Reorganized chapters by user workflow order.
■ Distributed the content to procedures, FAQs, and What-Ifs.
■ Moved the content that addressed admin users only into the Argus Safety
Administrator’s Guide.
■ Changed procedure titles and content to reflect user goals in the application.
■ Moved field descriptions as bulleted lists.
■ Updated or removed screenshots as necessary.
Go to Contents

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12 Argus 8.2 eTRMs (Bugs 26862322, 26898568, 26898513, and
26898732)
Technical Reference Manuals for Argus Safety, Argus Insight, Argus Analytics, and
Argus Mart are available on My Oracle Support under Patches 26862322, 26898568,
26898513, and 26898732. The patches are password protected. Registered users can log
a Service Request (SR) to obtain the password.
Other product TRM details to be included.
Go to Contents

13 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 that have purchased support 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 Release Notes – What's New Release 8.2

E96166-01
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