1 Prepare to Install Oracle Thesaurus Management System

This chapter includes:

1.1 Check Installation Documentation

Check these additional resources.

1.1.1 My Oracle Support Articles

Visit the My Oracle Support website at http://support.oracle.com for the most up-to-date installation information, including alerts, release notes, bulletins, White Papers, and patches.

The My Oracle Support website includes these important installation topics:

  • Oracle Thesaurus Management System 5.2.1 Release Notes (Article ID 2281526.1)

  • OLSA Known Installation and Configuration Issues (Article ID 1572864.1)

  • Oracle Clinical, Oracle Clinical Remote Data Capture, and Oracle Thesaurus Management System Security Configuration Guide available with the user documentation.

  • Oracle Health Sciences (Life Sciences/ Pharmaceutical/ Healthcare) Supported Technology Stacks (Article ID 180430.1)

  • Oracle Thesaurus Management System Installation Verification Test (Article ID 398443.1)

  • Oracle Thesaurus Management System Summary of Patches Available (Article ID 132626.1)

  • TMS Product Information Center page (Article ID 1343408.1): Check here for new notes and White Papers, including the performance White Paper and the Installation Verification Test, which are not available at the time of publication of this document.

1.1.2 User and Installation Documentation

The most current Oracle Thesaurus Management System user documentation, including this guide and the Oracle Clinical, Oracle Clinical Remote Data Capture, and Oracle Thesaurus Management System Security Configuration Guide, is available at:

https://docs.oracle.com/health-sciences/tms-521/index.html

1.2 Architecture

The architecture for TMS consists of three tiers: the database tier, the application tier, and the client tier.

Figure 1-2 illustrates the architecture and technology stack for TMS.

Figure 1-1 TMS Architecture and Technology Stack

Description of Figure 1-1 follows
Description of ''Figure 1-1 TMS Architecture and Technology Stack''

The database tier in a TMS environment includes the Oracle Database 12c Release 1 (12.1.0.2) software and the TMS database(s). In past releases, the database tier was called the back end.

The application tier includes:

  • TMS Forms Server — The Forms Server performs all forms processing, communicates the display changes to the client, and calls forms to query, update, select, and delete data from the database.

  • TMS Server Code— The Server Code consists of scripts used to create TMS databases.

  • TMS Reports Server — The Reports Server runs most batch reports, schedules all jobs, and creates PDF output for reports. Most TMS reports interface with the TMS Reports Server.

  • TMS Browser — The TMS Browser runs in a browser and does not required a plug-in. It allows users to browse dictionary terms and, if fully integrated with a clinical data system like Oracle Clinical, source terms and associated external system information.

The client tier communicate users' keystrokes and mouse movements to the application tier. It requires a browser and Browser Native Oracle JVM.

1.3 Network Topology

Figure 1-2 Oracle Thesaurus Management System Network Topology

Surrounding text describes Figure 1-2 .

Figure 1-2 shows how the Oracle Thesaurus Management System components and technology stack are related and provides an example of how the product can be installed. The left side of the Application Tier—APPHOST1—is a standard installation, while the whole—with APPHOST2—shows a multi-node middle tier installation using Oracle Clusterware.

In the client tier, end users' browsers communicate via HTTPS with the Oracle HTTP Server (OHS), which is located inside a firewall. When users log in, OHS detects the product they logged in to and consults formsweb.cfg to connect them to the appropriate application tier service.

The application tier comprises Oracle Application Server and Oracle WebLogic Server. The integrated tier has two domains:

  • FRDomain includes the Oracle Forms runtime service and Forms Server, and the Oracle Reports Server and engine, which run Oracle Thesaurus Management System forms and reports. It also includes the WebLogic Server Admin Server and Oracle Enterprise Manager.

    The Oracle Application Server domain must be named FRDomain and must use port number 7001.

  • OPADomain includes the WebLogic Server Administration Console, WebLogic Server Java, and OpaServer1, which are required to run the TMS Lite Browser and TMS reports. It also contains the database connections. Note that when you install the Oracle Enterprise Manager in the FRDomain, it serves for monitoring the OPADomain as well.

    The TMS Installer automatically creates the OPADomain. OPADomain must use port number 7101.

    You can distribute the application tier over multiple nodes in a network using Oracle Clusterware. The Admin Server is required only on the primary node.

    The WebLogic Server Node Manager exists outside the domains on the host. The Oracle Thesaurus Management System Installer automatically stops the Node Manager before each Java deployment and starts the Node Manager afterward so you do not need to do that.

    The database tier includes Oracle Database with Oracle Thesaurus Management System. The diagram shows a distributed installation integrated with Oracle Clinical using Oracle Real Application Clusters (RAC); this is one example of how it can be installed.

1.4 Software Requirements

For technology stack updates, see (ID 180430.1) on My Oracle Support.Oracle Health Sciences (Life Sciences/ Pharmaceutical/ Healthcare) Supported Technology Stacks (Article ID 180430.1).

Table 1-1 Oracle Thesaurus Management System Database Tier Technology Stack

Component Supported Version

Operating System

Oracle Linux 7.2 with Unbreakable Enterprise Kernel (UEK) 64 bit (US English)

Oracle Linux 6.4 with Unbreakable Enterprise Kernel (UEK) 64 bit (US English)

Oracle Solaris SPARC 10 and 11; 64-bit architecture (US English)

HP Itanium 11.31; 64-bit architecture (US English)

Windows Server 2012 Release 2 (US English)

Oracle Database

Oracle Database 12c Release 1 (12.1.0.2) Enterprise Edition, 64-bit

Compiler

For Oracle Linux x86-64: GCC-4.8.3

For Oracle Solaris SPARC 10 and 11: Sun Studio 12

For HP Itanium: HP C/aC++ for Integrity Servers B3910B A.06.27

Optional Software

Oracle Real Application Clusters (RAC) on Sun, HP, and Linux, including Exadata

Oracle Virtual Machine (OVM) 3.2

Pro*C/C++ Release 12.1.0.1

Table 1-2 Oracle Thesaurus Management System and TMS Lite Browser Application Tier Technology Stack

Component Supported Version

Operating System

Microsoft Windows Server 2012 Release 2

Oracle WebLogic Server

Oracle WebLogic Server 12c Release 2 (12.2.1.2)

Oracle Fusion Middleware Infrastructure

Oracle Fusion Middleware Infrastructure 12c Release 2 (12.2.1.2)

Oracle Application Development Framework

Oracle Application Development Framework 12c Release 2 (12.2.1.2)

Note: Included with Oracle Fusion Middleware Infrastructure.

Oracle Forms and Reports

Oracle Forms and Reports 12c Release 2 (12.2.1.2)

Oracle Java Development Kit (JDK)

Oracle Java Development Kit 1.8 Update 111 or later (also known as JDK 1.8 or JDK 8)

Oracle Java Runtime Environment (JRE)

Oracle Java Runtime Environment 1.8 (also known as JRE 1.8 or JRE 8)

Microsoft Visual Studio

Visual C++ in Microsoft Visual Studio 2012 (x64 distributed)—Required for Oracle WebLogic Server 12c (12.2.1.2) and Oracle Forms and Reports 12c (12.2.1.2). Can be used to invoke API methods from custom clients.

Table 1-3 Oracle Thesaurus Management System and TMS Lite Browser Client Tier Technology Stack

Component Supported Version

Operating Systems

Microsoft Windows 10; 32-bit or 64-bit architecture (US English)

Microsoft Windows 7; 32-bit or 64-bit architecture (US English)

Microsoft Windows Server 2012, Release 2 (US English)

Microsoft Windows 8/8.1; 64-bit architecture

Mobile Operating Systems

iOS 7.1.2—iPad and OS X 10.7.5—for the TMS Lite Browser only

Supported Browsers

Microsoft Internet Explorer versions depend on the operating system:

  • Microsoft Windows 10: Internet Explorer 11 and Microsoft Edge v25

  • Microsoft Windows 7 (64-bit): Internet Explorer 11

  • Microsoft Windows Server 2008, Release 2, Service Pack 1, 64-bit: Internet Explorer 11

  • Microsoft Windows 8/8.1, 64-bit: Internet Explorer 11

Safari 7.0.3 on iOS 7.1.2—for TMS Lite Browser only

Adobe Reader

Releases 8x, 9.x, 10.x, 11.x (US English). Required for viewing PDF reports.

1.4.1 Database Tier Operating System Requirements

To verify that your system fits the requirements listed in Table 1-1, "Oracle Thesaurus Management System Database Tier Technology Stack" do the following in UNIX or Windows:

UNIX To verify UNIX operating system details, enter the following command:

uname -a

In addition, to verify the update version for Linux, enter the following command:

cat /etc/issue

Windows To verify Windows operating system details, navigate to the Control Panel, then System and Security, then System.

1.5 Supported Configurations with Oracle Data Guard and RAC

Oracle Thesaurus Management System 5.2.1 supports a distributed environment over a network or within an Exadata machine without using Oracle Thesaurus Management System replication.

This section contains:

See information about running PSUB in a RAC environment in the Oracle Clinical Installation Guide.

1.5.1 Supported Configurations with Oracle Real Application Clusters (RAC)

Oracle Clinical was re-architected in Release 5.0 to support Oracle Real Application Clusters (RAC). The Parameterized Submission process (PSUB), which runs and schedules most jobs in Oracle Clinical, no longer uses DBMS pipes, which can only be used within a single database instance, for communication between the user session and the PSUB service. It now uses Oracle Advanced Queuing.

Because databases have traditionally been constrained to run only on a single server, customers have typically followed a hardware "scale-up" strategy for the database tier: Whenever the database server becomes a bottleneck to overall application performance, the server is replaced with a larger, faster machine. While this approach is well understood, it can be highly disruptive to ongoing business.

Oracle Real Application Clusters (RAC) provides an alternative approach for scaling database performance. It is designed to tolerate server failures with little impact to mission-critical applications and users. As workloads and user connections are increased, additional nodes (servers) can be easily added to the cluster. Each server runs against the same database simultaneously. This approach is less disruptive to ongoing business operations, more reliable, and less expensive to implement.

RAC nodes can be individual computers in a network or nodes on an Oracle Exadata machine. RAC shares the database internally among all nodes so that even if the node where the database was originally installed goes down, the other nodes can still access the database. You can configure RAC nodes as follows:

1.5.1.1 Node 1: Install and Set Up Everything Required for Oracle Clinical

  • Oracle Real Application Clusters (RAC)—installed with Oracle Database

  • Oracle Thesaurus Management System database server code

  • Oracle Thesaurus Management System database(s)

  • Run the Oracle Clinical PSUB service on this node (one per database)

  • Create user-specific PSUB log file directories for randomization, batch data load, and labs batch jobs that require input files

  • Enter PSUB-related values in local reference codelist OCL_STATE

  • Install SAS 9.3 (Optional)

1.5.1.2 Node 2: Install the Minimum Required as a RAC Node

Install Oracle Database with Oracle Real Application Clusters (RAC).

You can have multiple nodes set up this way, each accessing the same database(s). Additional nodes set up this way improve database performance.

1.5.1.3 Node 3: Install Everything Required for Oracle Clinical as Backup

In case either the PSUB service or Node 1 itself fails, install all required software on another node so that you can start the PSUB service as quickly as possible to continue normal operation. PSUB can run on only one server at a time.

A node set up this way also improves performance but requires additional maintenance; any Oracle Thesaurus Management System database server patches you install on the primary node (Node 1 in this example) must also be installed on this node.

  • Install Oracle Real Application Clusters (RAC) and Oracle Database

  • Install Oracle Thesaurus Management System database server code (includes PSUB server code)

  • Create the same PSUB directory structure as on Node 1 so that the OCL_STATE reference codelist values on the middle tier still work. If you use NFS to share the files, users will still be able to access files for jobs performed on the other node unless the node itself fails. For more information see the PSUB chapter in the Oracle Clinical Installation Guide.

    Note:

    You do not need to reinstall the Oracle Thesaurus Management System database.

You can have multiple nodes set up this way, each accessing the same database(s).

1.5.1.3.1 Recommended Options for RAC

Oracle Thesaurus Management System 5.2.1 is supported with an Oracle Real Applications Cluster (RAC) distributed database installation on UNIX. Oracle recommends:

  • Configuring a Maximum Availability Architecture (MAA) in which you use Oracle RAC for both your primary and standby database, synchronized using Oracle Data Guard.

  • Using the Single Client Access Name (SCAN) option. This RAC feature provides a single name for clients to access Oracle databases running in a cluster. The benefit is that the client's connect information does not need to change if you add or remove nodes in the cluster. Having a single name to access the cluster allows clients to use the EZConnect client and the simple JDBC thin URL to access any database running in the cluster, independent of which server(s) in the cluster the database is active. SCAN provides load balancing and failover for client connections to the database. The SCAN works as a cluster alias for databases in the cluster.

  • SCAN is configured during the installation of Oracle Grid Infrastructure that is distributed with Oracle Database. Oracle Grid Infrastructure is a single Oracle Home that contains Oracle Clusterware and Oracle Automatic Storage Management (ASM). You must install Oracle Grid Infrastructure first in order to use Oracle RAC.

1.5.2 Supported Configurations with Oracle Data Guard

The following Oracle Data Guard configurations are supported. All Oracle Thesaurus Management System components (database server, database) must be installed on each node.

  • Standalone server with Oracle Data Guard failover

  • Oracle Clusterware for One Node with Oracle Data Guard failover

  • Oracle RAC One Node with Oracle Data Guard failover

  • Multi-node RAC with Oracle Data Guard failover

Oracle Data Guard is included in Oracle Database Enterprise Edition.

1.6 Download the Software

1.6.1 Create Staging Areas

  1. Create one staging area each on the database server and on the application server.

  2. Create one directory, in each staging area, for each media pack disk, patch, or other software unit, and give the directory a logical name.

Table 1-4 Software to Download to the Database Server Staging Area

Disk or Patch Name Source

Oracle Thesaurus Management System 5.2.1 Documentation

https://docs.oracle.com/health-sciences/tms-521/index.html

Oracle Database 12c Release 1 (12.1.0.2) — Linux x86-64

Media pack

Oracle Database 12c Release 1 (12.1.0.2) — Solaris Sparc 64

Media pack

Oracle Database 12c Release 1 (12.1.0.2) — HP IA

Media pack

Oracle Database 12c Release 1 (12.1.0.2) — Windows x64

Media pack

Table 1-5 Software to Download to the Application Server Staging Area

Disk or Patch Name Source

Oracle Thesaurus Management System 5.2.1 Documentation

https://docs.oracle.com/health-sciences/tms-521/index.html

Oracle Thesaurus Management System Release 5.2.1

Media pack

Oracle WebLogic Server 12c Release 2 (12.2.1.2)

Media pack

Oracle Fusion Middleware Infrastructure Installer for Oracle WebLogic Server 12c

Media pack

Oracle Forms and Reports 12c Release 2 (12.2.1.2) for Windows x64 (part of Oracle Application Server)

Media pack

Oracle Database 11g Release 2 Client (11.2.0.1.0) for Microsoft Windows (x64); see Section 1.6.4, "Download Oracle Database Client"

https://edelivery.oracle.com

Oracle Java Database Connectivity (patches 19028811 and 21043834)

My Oracle Support

Oracle Reports Developer patch 22334822

My Oracle Support

Oracle Java Development Kit (JDK) 1.8; see Section 1.6.5, "Download Oracle Java Development Kit"

My Oracle Support

Java Runtime Environment (JRE) 1.8; see Section 1.6.6, "Download the Java Runtime Environment"

www.oracle.com

Adobe Reader; see Section 1.6.7, "Download Adobe Reader"

http://www.adobe.com/

Microsoft Visual C++ 2012 Redistributable (x64) - 11.0.61030

https://www.microsoft.com/en-us/download/details.aspx?id=30679

1.6.2 Download the Oracle Thesaurus Management System 5.2.1.0.x Media Pack

Note:

To receive a physical media pack with all the required DVDs, contact Oracle Support. To expedite your request you can either call Oracle Support directly or open a Service Request (SR) selecting problem category: Version Update Request.

To download the software:

  1. Go to http://edelivery.oracle.com and log on.

  2. From the Search by drop-down list, select Product.

  3. In the field next to Search by, type Oracle Thesaurus Management System.

  4. From the Select Platform drop-down list, select the checkbox for your operating system.

  5. Click Continue.

  6. Review the media packs you want to download and click Continue.

  7. Check the agreement and click Continue.

  8. Download each disk into the appropriate directory in the appropriate staging area as shown in Table 1-4, "Software to Download to the Database Server Staging Area". Each download consists of a single file named part_number.zip.

  9. Extract each part_number.zip file into a meaningfully named directory.

  10. For the Oracle Thesaurus Management System software, extract TMS_Win_MiddleTier_Installer.zip on the application server.

1.6.3 Download Patches from My Oracle Support

Note:

If you have already performed these steps for Oracle Clinical, skip to the next section.

To download each required patch indicated in Section 1.6.1, "Create Staging Areas" from My Oracle Support:

  1. Go to My Oracle Support at https://support.oracle.com and sign in.

  2. Click the Patches & Updates tab, then enter the patch number in the Patch Name or Number is field and click Search.

  3. Click the link for your operating system and download the patch file to the appropriate directory in the staging area.

  4. Extract the .zip file.

1.6.4 Download Oracle Database Client

Download Oracle Database 11g Release 2 Client (11.2.0.1.0) for Microsoft Windows (x64) to the application server staging area.

  1. Go to https://edelivery.oracle.com and log on.

  2. In the Search by field, type Oracle Database Client 11.2.0.1.0.

  3. Click Select Platform and select the checkbox for your operating system.

  4. Click Continue.

  5. Review the software you are about to download and then click Continue.

  6. Read the license agreement and select the checkbox to confirm that you have read and accept the terms, then click Continue.

  7. In the File Download dialog box, click Download.

1.6.5 Download Oracle Java Development Kit

To download and install JDK 1.8.0_111:

  1. Go to My Oracle Support at https://support.oracle.com and sign in.

  2. In the Search Knowledge Base field in the upper right, enter: 1439822.1

    A page appears with a list of documents.

  3. Click the link All Java SE Downloads on MOS [Article ID 1439822.1].

  4. Scroll down to the list of JDK versions to Oracle JDK 8 Update 111 (Patch 24359908).

    Note:

    Check Oracle Health Sciences (Life Sciences/ Pharmaceutical/ Healthcare) Supported Technology Stacks (Article ID 180430.1) on My Oracle Support to see if a more recent JDK version is supported.

  5. Click the patch number link.

  6. Select Microsoft Windows x64 (64-bit) and click ReadMe to read the release notes and Download to download the patch to the staging area.

Installation instructions are in Section 3.4, "Install Oracle Java Development Kit."

1.6.6 Download the Java Runtime Environment

You must make Java Standard Edition (SE) Runtime Environment (JRE) 1.8.0_111 available for download to user computers so that they can use Oracle Thesaurus Management System. You will configure the Launch page to allow users to download JRE in Section 7.4, "Making the Java Runtime Environment Available for Download". In preparation for this, download JRE to the application server.

Note:

Check Oracle Health Sciences (Life Sciences/ Pharmaceutical/ Healthcare) Supported Technology Stacks (Article ID 180430.1) on My Oracle Support to see if a more recent JRE version is supported.

To download JRE 8 Update 111:

  1. On the application server, go to the following Oracle website:

    http://www.oracle.com/technetwork/java/javase/downloads/index.html

  2. Under Java SE 8u111, click the Download button for JRE.

  3. Select the Windows x86 Offline version.

    Note:

    This is the version for 32-bit browsers (not operating systems). The default browser for Windows machines is 32-bit, but Windows machines also come with a 64-bit version. To support the 64-bit version, you must either customize your Launch page to point to sunjpi64.exe or instruct users with 64-bit browsers to download the 64-bit version of JRE from the link in Step 1.

  4. Download the file to the staging area in a recognizably named directory.

1.6.7 Download Adobe Reader

Adobe Reader is required on the Reports Server and on client computers. At this time, no particular version is required.

  1. Download Adobe Reader from http://www.adobe.com.

1.6.8 Download Oracle Critical Patch Updates

Every quarter, Oracle provides Critical Patch Updates (CPUs) to address security vulnerabilities. The latest CPU patch contains all the fixes from previous patches.

Check My Oracle Support article ID 121863.1, Oracle Health Sciences Supported Technology Stacks, for the latest CPU patch tested with Oracle Health Sciences applications. The article includes a link to separate articles about each one. Download the required patches on every computer with an Oracle Home.

1.7 Use the Silent Installer (Optional)

You can run any of the Oracle Universal Installers—including the Oracle Thesaurus Management System Installers—in silent mode. This may be useful to promote uniform installations in many sites or on many computers.

TMS ships with .rsp (response) files that include the parameter prompts and sample parameter values for each component. They are located on the media pack's Oracle Thesaurus Management System 5.2.1 disk in TMS\application_server.zip\Disk1\ stage\Response, and include:

Table 1-6 Response Files and Parameter Information

Component Installed Response File Parameter Information

TMS DB Server

oracle.pharma.tms.server.Complete.rsp

Section 4.1.1

TMS Database

oracle.pharma.tms.db.install.Master.rsp

Section 4.3.2

TMS Database Registration

oracle.pharma.tms.db.register.Custom.rsp

Section 4.5.3

TMS Front End

oracle.pharma.tms.frontend.Custom.rsp

Section 5.2.1

TMS Reports Server

oracle.pharma.tms.reportserver.Complete.rsp

Section 5.4.2

TMS Upgrade

oracle.pharma.tms.db.upgrade.Master.rsp

Section 6.4.3

  1. Open the file in a text editor and enter values directly.

  2. Run the file.

    In UNIX:

    ./runInstaller -responseFile response_file_name

    In Windows (as an administrator):

    setup.exe -responseFile response_file_name

  3. When you run the file at each location, edit the local parameters as required.

Alternatively, you can run the Installer once, entering values manually, and record the process to create a response file.

Run the file.

In UNIX:

./runInstaller -record -destinationFile response_file_name

In Windows (as an administrator):

setup.exe -record -destinationFile response_file_name

For more information see Oracle Universal Installer documentation at:

1.8 Choose a Character Set

Note:

If you have already installed or upgraded Oracle Clinical, you should have already selected a character set and can skip this section.

Oracle Health Sciences supports certain character sets for each product or each combination of integrated products. For TMS, Oracle strongly recommends that you use the AL32UTF8 character set. TMS also supports UTF8, US7ASCII, WE8ISO8859P1, or any single byte character set.

TMS uses the NLS_LANG environment variable to control the language, territory, and character set used for database connections. The NLS_LANG variable concatenates the three components as LANGUAGE_TERRITORY.CHARSET.

The TMS Installer sets the default value for the TMS application tier to AMERICAN_AMERICA.AL32UTF8. You set the value during database creation outside the Installer.

  • You must set the CHARSET component of the NLS_LANG variable to match the character set of the database.

  • You must use the same character set on the database tier and the application tier. If you select US7ASCII for the database tier and AL32UTF8 or UTF8 for the application tier, for example, Oracle Clinical stores some special characters incorrectly in the database.

1.9 Download the Latest TMS Patches

Check Oracle Thesaurus Management System Summary of Patches Available (Article ID 132626.1) on My Oracle Support for any TMS patches for this release and download them. You will apply these patches in Section 7.1, "Patch TMS".

1.10 Integrate TMS with Other Products and Options

You can integrate TMS with other products and options and develop applications that read data from TMS. Each product listed below must be purchased separately.

1.10.1 Oracle Clinical Remote Data Capture Onsite

Oracle Clinical Remote Data Capture Onsite (RDC Onsite) is an electronic data capture (EDC) Web application that works with studies that are defined and designed using Oracle Clinical. You can use RDC Onsite to collect, perform immediate validation on, review, verify, approve, and report clinical data collected during a patient visit in a clinical study. Patient data is stored in the Oracle Clinical database. You can use Oracle Clinical features including batch validation, discrepancy management, mass changes, and data extract with data collected using RDC Onsite.

1.10.2 Oracle Clinical

When fully integrated with Oracle Clinical, TMS processes new and updated patient data during each Oracle Clinical batch validation and either automatically codes incoming data—those that match standard terms exactly or match previously manually coded terms exactly—or creates an omission that must be manually coded in TMS. TMS can return to Oracle Clinical related terms from one or more levels of the standard terminology—for example the preferred term and system organ class in MedDRA, or the preferred name and Anatomical-Therapeutic-Chemical Level 1 term in WHO-Drug—for each coded term, associated with the correct RDCI (collected CRF).

You can install TMS and Oracle Clinical on the same application tier or on different application tiers. You must install both products on the same database if you want integrate the two systems. Oracle recommends installing Oracle Clinical before TMS.

For more information, see the Oracle Thesaurus Management System Installation Guide and the Oracle Thesaurus Management System User's Guide.

1.10.3 Oracle Health Sciences Data Management Workbench and Oracle Life Sciences Data Hub

Oracle Health Sciences Data Management Workbench (DMW) allows you to do data management on InForm and lab data in a single location. You can integrate TMS with DMW to code InForm and lab terms in TMS.

When fully integrated with Oracle Life Sciences Data Hub (LSH), TMS processes new and updated patient data during each Oracle LSH transformation and either automatically codes incoming data—those that match standard terms exactly or match previously manually coded terms exactly—or creates an omission that must be manually coded in TMS and a discrepancy in Oracle LSH. TMS can return to Oracle LSH related terms from one or more levels of the standard terminology—for example the preferred term and system organ class in MedDRA, or the preferred name and Anatomical-Therapeutic-Chemical Level 1 term in WHO-Drug—for each coded term, associated with the collected CRF.

1.10.4 Custom Applications for TMS

You can build custom applications for TMS:

See the Oracle Thesaurus Management System Technical Reference Manual for proprietary information about data access, internal tables, and APIs. Contact Oracle Support to obtain a free electronic copy of the manual. You must be a licensed customer.