1 Prepare to Install Oracle Clinical

1.1.1 My Oracle Support Articles

Visit the My Oracle Support website at https://support.oracle.com for the most up-to-date installation information, including:

• Oracle Clinical 5.2 Release Notes (ID 2221824.1)

• OLSA Known Installation and Configuration Issues (ID 1572864.1)

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

• Oracle Clinical Summary of Patches Available (ID 121863.1)

• Oracle Clinical/RDC Product Information Center (ID 1331795.1): 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 Clinical and Oracle Clinical Remote Data Capture (RDC) Onsite user documentation, including this guide and the Oracle Clinical, Oracle Clinical Remote Data Capture, and Oracle Thesaurus Management System Security Configuration Guide, is located at:

http://docs.oracle.com/health-sciences/oc-rdc-52/index.html

1.4.1 Database Tier Operating System Requirements

To verify that your system fits the requirements listed in Table 1-1, "Oracle Clinical 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.

1.5.1 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:

1.5.2 Supported Configurations with Oracle Data Guard

The following Oracle Data Guard configurations are supported. All Oracle Clinical 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.

1.6.1 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.

1.6.2 Download the Oracle Clinical 5.2.0.0.x Media Pack

To download the software:

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

2. From the Search by list, select Product.

3. In the field next to the Search by list, type Oracle Clinical.

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

5. Click Continue.

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

7. Read the license agreement and select the checkbox to accept the license agreement.

8. Click Continue.

9. Download each disk into a recognizably named directory in the appropriate staging area.

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

11. For the Oracle Clinical software, extract the appropriate .zip file for the server:

    • On the database server, extract server_code_platform.zip.

    • On the application server, extract oc_middletier_installer.zip.

1.6.3 Download Patches from My Oracle Support

To download a patch 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 a recognizably named directory in the appropriate staging area.

4. Extract the .zip file.

1.6.4 Download Oracle Java Development Kit

To download and install JDK:

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

   Note:

   Check Oracle Clinical Summary of Patches Available (Article ID 121863.1) on My Oracle Support to see if a more recent 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 in a recognizably named directory.

Installation instructions are in Section 6.4, "Install Oracle Java Development Kit".

1.6.5 Download the Java Runtime Environment

Oracle Clinical and the RDC Administration application require that Java Standard Edition (SE) Runtime Environment (JRE) 1.8.0.111—also known as JRE 8 Update 111—exist on the user's computer.

The Launch page is configured to prompt users to install JRE if it does not exist on their computer. To make this work, you need to download JRE into the OPA_HOME\html directory and rename it; see Section 7.4, "Make the Java Runtime Environment Available for Download".

To download JRE:

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

   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 it to the staging area in a recognizably named directory.

1.6.6 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.

1.6.7 Download JSpell (Optional)

The Oracle Clinical Graphic Layout Editor supports the JSpell Spell Checker SDK for Java J2EE for use in checking the spelling of text objects in graphic layouts.

The JSpell Spell Checker SDK is a third-party product from Page Scholar Inc. You must purchase the product separately.

1. Download JSpell SDK for Java J2EE from http://www.jspell.com/java-spell-checker.html to the staging area in a recognizably named directory.

2. Extract jspellsdk.zip.

Additional instructions are in Section 7.7, "Install and Configure JSpell Spell Checker SDK (Optional)".

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.

Installing Oracle Clinical also installs Oracle Remote Data Capture (RDC) Onsite. For information about using RDC, see the Oracle Clinical Remote Data Capture Onsite User's Guide. For license information, see RDC and Oracle Clinical Licenses.

1.10.2 Oracle Thesaurus Management System

Oracle Thesaurus Management System (TMS) allows you to code specified patient data to standard terminologies such as MedDRA and WHO-Drug so that the data can be accurately analyzed. 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 Life Sciences Data Hub

Oracle Life Sciences Data Hub (Oracle LSH) is a powerful data warehouse and transformation tool with built-in version control, data auditing, lifecycle management, and validation tools. Oracle LSH includes adapters specifically designed to load most metadata and patient data from Oracle Clinical into Oracle LSH. In Oracle LSH you can then, for example, create your own reports on study patient data, merge data from multiple trials and create reports on cross-study data, and view data using state-of-the-art visualization tools.

You can load Oracle Clinical metadata and Oracle LSH converts it to appropriate LSH objects, for example:

• Oracle LSH loads all Oracle Clinical Questions and converts them to Oracle LSH Variables.

• If a Question is associated with a Discrete Value Group (DVG) in Oracle Clinical, Oracle LSH converts the Question to a Parameter and converts its DVG values to a list of allowable values for the Parameter.

• Oracle LSH loads all Oracle Clinical Question Groups and converts them to Oracle LSH Table definitions with Columns based on the Variables corresponding to each Question in the Question Group.

Other Oracle Clinical adapters include:

• Oracle Clinical SAS and Oracle Data Extract Views—load patient data from views you create in Oracle Clinical

• Oracle Clinical Stable Interface—loads the metadata of all Oracle Clinical tables that are part of Oracle Clinical's stable interface.

• Oracle Clinical Design and Definition—loads DCMs, DCIs, Procedures, Copy Groups, and Data Extract queries and templates.

• Oracle Clinical Labs—load lab reference ranges and associated information from Oracle Clinical Labs-related tables.

• Oracle Clinical Randomization—loads real or dummy treatment pattern information for Oracle Clinical studies.

• Oracle Clinical Study Data—loads study-specific non-patient data into LSH, including discrepancies, data clarification forms, patient status information, and page tracking information.

In addition, other non-Oracle Clinical-specific adapters allow you to load data from any Oracle table or view, text file, SAS data set, or SAS CPORT or XPORT file.

1.10.4 SAS

Oracle Clinical supports integration with the statistical software application SAS 9.4 for data extract.

1.10.5 Custom Applications for Oracle Clinical

You can build custom applications for Oracle Clinical:

• See the Oracle Clinical Stable Interface Technical Reference Manual for proprietary information about data access, internal tables, and APIs. The Oracle Clinical Stable Interface provides access to data and a smooth transition between Oracle Clinical versions. Contact Oracle Support to obtain a free electronic copy of the manual. You must be a licensed customer.

• See the Oracle Clinical Application Programming Interface Guide for information about using Oracle Clinical's Data Capture API.