Contents

List of Examples

List of Figures

List of Tables

Title and Copyright Information

Preface

• Audience
• Documentation Accessibility
• Finding Information and Patches on My Oracle Support
• Finding Oracle Documentation
• Related Documents
• Conventions

Part I Configuration Tasks

1 Setting Up User Accounts

• Creating an Administrator User Account
• Setting Up Required Accounts and Directories
  • Setting Up a Report Server Log Directory
  • Creating an Operating System Account
    • Accounts on UNIX Systems
    • Accounts on Windows Systems
  • Creating a PSUB Log Directory
    • Making the PSUB Root Directory Accessible
  • Ensuring PSUB Execution Permission (UNIX Only)
  • Modifying the RXCPROD Account's Profile
• Running the Add User Script
  • About the Add User Script
  • Running the Add User Script in UNIX
  • Running the Add User Script in Windows
  • Required Parameters
  • Optional Parameters
• Maintaining Oracle User and Group User Accounts
  • Adding a User to a Group User Account
• Granting Data Access to User and Group User Accounts
  • Granting Data Access to Programs and Projects
  • Granting Data Access to a Study
  • Superuser and Study Access Interaction
  • Revoking User Access
• Granting Data Access to RDC Users
  • Granting Automatic Access in RDC to Studies Granted in Oracle Clinical
  • Configuring Study and Site Security Privileges
  • Changing the Default Access to DCIs
• Granting Additional Database Roles to User Accounts
  • Additional Database Roles for RDC Users
  • Additional Database Roles for Oracle Clinical Users
• Setting Up Data Extract Users
  • Creating an Operating System Account on the SAS Server
  • Adding User to the OCLSASCR User Group (UNIX only)
  • Creating a Queries Table for a Data Extract User
• Setting Up Power Users
  • UNIX
  • Windows
• Setting Up Passwords
  • Changing the Password for a Schema or Role
  • Changing the Password for a User
  • Enforcing Password Security
  • Auditing Passwords
  • Operating System Passwords
    • UNIX Passwords
    • Windows Passwords

2 Oracle Clinical Menu-Based Security

• Predefined Database Roles
• Creating and Modifying Database Roles
  • Viewing Menu-Role Associations
    • Organization of the Menu Module Tree
    • Navigating the Menu Modules
  • Modifying Menu-Role Associations
  • Creating Custom Database Roles
    • Creating Custom Roles for Restricting DCI Access
  • Associating Roles with Menus
  • Adding a Custom Role to OPA_MENU_ROLES
  • Granting a Custom Role Access to a Custom Module
• Adding Menu Items to Oracle Clinical

3 Configuring Discrepancy Management

• Mapping Database Roles to User Roles
• Specifying User Roles for the Oracle Clinical Discrepancy Database
  • Assigning Function Privileges and Layouts
    • Assigning and Removing Function Privileges
    • Assigning Custom Layouts
• Customizing Layout Definitions
• Customizing Profiles
  • Filtering Profile Views
    • Specifying Default Profile Criteria
    • Locking Profile Criteria
    • Adding SQL Statements
    • Filtering Profile Views by Review Status
    • Updating Status Codes
    • Filtering Profile Views by Discrepancy Field
• Customizing Flexfields
  • DISC_FLEX1 and DISC_FLEX2
  • DISC_FLEX1_VALUES and DISC_FLEX2_VALUES
  • Example
• Defining Reason Codes for Discrepancies
  • Reason Codes and Descriptions for Manual Discrepancies
  • Reason Codes and Descriptions for Univariate Discrepancies
  • Reason Codes and Descriptions for Multivariate Discrepancies
• Defining the Possible Review Statuses for Discrepancies
  • Default Entries for the DISCREPANCY REV STATUS CODE Codelist
  • Rules for the DISCREPANCY REV STATUS CODE Codelist
• Defining Resolution Reasons for Discrepancies
• Setting Values in the OCL_STATE Local Reference Codelist
• Configuring Role-Specific Discrepancy Management for RDC
  • Configuring Discrepancy Display by User Role
    • How RDC Indicates Discrepancies in the User Interface
    • Rules for the DISCREPANCY STATUS role Codelists
    • Comparison of the Default Values for the DISCREPANCY STATUS role Codelists
    • DISCREPANCY STATUS CRA
    • DISCREPANCYSTATUS DM
    • DISCREPANCY STATUS INV
    • DISCREPANCY STATUS SITE
  • Configuring the Actions Allowed on Discrepancies
    • Rules for the DISCREPANCY ACTIONS role Codelists
    • DISCREPANCY ACTIONS CRA
    • DISCREPANCY ACTIONS DM
    • DISCREPANCY ACTIONS INV
    • DISCREPANCY ACTIONS SITE
  • Preventing Update to OTHER Discrepancies
• Configuring Study and Site Security for Discrepancy Management
  • Updating a Discrepancy
  • Navigating to Data Entry
• Setting Up Data Clarification Forms (DCFs)
  • Defining DCF Statuses and their Behavior
  • Laying Out the DCF
• Creating Reusable Standard Text for Discrepancies and DCFs
  • Creating New Standard Text
  • Inserting Replacement Parameters
  • Customizing Default Standard Text Entries

4 Configuring the Mass Changes Utility

• Creating and Assigning Mass Changes Roles
• Customizing Mass Changes Local Codelists
• Customizing the Field Display on the Candidate Data Set Form

5 Configuring Data Entry and User Preferences

• Customizing Data Entry Behavior
  • Define Data Entry Configuration Settings
    • Configure Database-Level Data Entry Settings
    • Configure Study-Level Data Entry Settings
    • Configure User-Level Data Entry Settings
  • Configuring Additional Data Entry User Preferences
  • Configuring Privileged Update
    • Set Privileged Update Using Configuration Settings
    • Set Privileged Update Using Study/Site Security
• Customizing the Oracle Clinical Log-in Window Layout
  • Using the Log-in Layout Editor
  • Modify the Received DCI window
  • Modifying the Received DCM Window
  • Modifying the Smart Received DCM Window
• Setting DCI Form Default Values for RDC Data Entry and the Patient Data Report
  • Setting and Enforcing Values
  • Settings
    • DCI Form Definition
    • DCI Form Runtime
    • General
    • Graphic Layout Editor/Updater
    • Graphic Layout Generator - General
    • Graphic Layout Generation - DCMS
    • DCI Form Generation Defaults
    • Default Settings for Showing DCM Header Fields
    • Default DCM Header Field Prompts
    • Version Migration
    • Patient Data Report
    • Validation
• Customizing Flex Fields for DCI Forms
  • How Flex Fields Work
  • Flex Field Components
    • Shipped Functions
• Customizing CRF Column Headers in the RDC Classic Surround
  • Default Behavior
  • Functions Used to Modify CRF Column Headers
  • Functions
• Customizing Online Help
  • Modifying Calls to Online Help Topic Files
  • Copying Xhelp Topic Files
  • Creating Custom Help Files

6 Configuring Data Extract

• Configuring Default Installation Data Extract Settings
• Setting Values in Data Extract-Related Reference Codelists
• Creating Tablespaces for Data Extract Tables and Indexes
  • Creating Tablespaces
  • Entering Tablespace Names in Reference Codelists
  • Creating Data Extract Access Accounts Using Local Tablespaces
• Customizing Data Extract Views
• Generating Data Extract Views
  • Running gen_views on UNIX Platforms
  • Running gen_views on Windows
• Enabling the View Builder and Converting Views
  • Converting Views
  • Enabling the View Builder in a Study
• Controlling Access to Data Extract Views

7 Reference Codelists

• Overview
• Adding a Value to a Reference Codelist
  • Modifying a Value in a Reference Codelist
  • Running the Reference Codelists Report
  • Maintain/Query Reference Codelists Windows
    • Access
    • Components
    • Usage
• Local Reference Codelists
  • BATCH QUEUE NAME
  • DB_LINKS
  • DCF COMMENT TEXT
  • DCF DEFAULT FOOTERS
  • DCF DEFAULT HEADERS
  • DCF REPORT LABELS
  • DISC COLS
  • DISC_FLEX1 and DISC_FLEX2
  • DISC_FLEX1_VALUES and DISC_FLEX2_VALUES
  • FLD RXCMCMCD RDCI DELETE
  • FLD RXCMCMCD RDCI KEY
  • FLD RXCMCMCD RDCM KEY
  • FLD RXCMCMCD RESPONSE
  • IND DISC COLS
  • MAN DISC COLS
  • MANHD DISC COLS
  • MC CDS SORT ORDER
  • MC COLUMNS
  • MULTI DISC COLS
  • NLS_CONFIG
  • OCL MC PREFS
  • OCL_DE_CONFIG
    • DVG List of Values STYLE
    • COMMCHGREAS_REQ
    • JUSTENTERP1TIME
    • JUSTENTERP2TIME
    • RSTRCT LCKD CRF
  • OCL_DE_PREFS
  • OCL_JOB_PREF
  • OCL MC PREFS
  • OCL_MENU_ACCESS
  • OCL_STATE
    • SERVER_NAME
    • LOCATION_CODE
    • DB_BLOCK_SIZE
    • TEMP_TABLES
    • DM_PROMPT
    • DISC_DCM_PROMPT
    • PROC_LAB_ALIAS
    • BOOK_ASSIGN
    • TMS_FAIL_BV_ACT
    • UPD_FV_INCREM
  • PRINT QUEUE NAME
  • PUBLIC_DB_LINKS
  • REPORT_SERVER
  • SAS_QUEUE
  • SQL FUNCTIONS
  • TMS_OPTIONS
  • UNI DISC COLS
• Installation Reference Codelists
  • APPLICATION AREA CODE
  • APPLICATION SYSTEM NAME
  • APPROVE VERIFY RETAIN CODE
  • APPROVE VERIFY REVERSE CODE
  • BLIND TYPE CODE
  • CLINICAL PHASE
  • COUNTRIES
  • CRF PAGE NUMBERING SCHEME
  • CRF PAGE STATUS CODES
  • CRF PAGE STATUS QUERY
  • DATA CHANGE REASON TYPE CODE
  • DATA CHANGE REASON2 TYPE CODE
  • DCF LOCK CONDITIONS
  • DCF_OPTIONAL_STATUS_CODES
  • DCF STATUS CODES
  • DCIF CHECKBOX SIZE
  • DCIF FONT TYPESIZE
  • DCIF PAGE DEFINITION
  • DCM DCI QG TYPE CODE
  • DISCREPANCY ACTIONS ROLE Codelists
  • DISCREPANCY MESSAGES
  • DISCREPANCY RESOLU TYPE CODE
  • DISCREPANCY REV STATUS CODE
  • DISCREPANCY STATUS ROLE Codelists
  • DISCREPANCY NO OTHER UPDATE
  • DISCRETE VAL GRP TYPE CODE
  • DISC_STDST_VALUES
  • DOSE FORM TYPE CODE
  • DOSE FREQUENCY TYPE CODE
  • DX_CONFIG
  • DX_EXTENDED_ATTRIBUTES
  • DX_INDEX_TABLESPACE
  • DX_KEY_NAME
  • DX_ROLES
  • DX_VIEW_TABLESPACE
  • EXECUTION SCHED CODE
  • EXP DESIGN TYPE CODE
  • EXTERNAL_TRANS_TYPE
  • LAB RANGE SUBSET CODE
  • MANUAL SOURCE TYPE CODE
  • MAPPING_TYPE
  • MEDICAL EVAL TYPE CODE
  • OBJECTIVE TYPE CODE
  • OCL_DOMAINS
  • OCL_INSTALLATION
  • OCL_OPTIONS_TYPE_CODE
  • OPA_MENU_ROLES
  • PATIENT STATUS CODE
  • PLAN STUDY INT TYPE CODE
  • PROCEDURE TYPE CODE
  • QUESTION CATEGORY TYPE CODE
  • RDCI CHANGE REASON TYPE CODE
  • RDCI CHANGE REASON2 TYPE CODE
  • REGION TYPE CODE
  • RETIREMENT REASON TYPE CODE
  • ROUTE OF ADMIN TYPE CODE
  • SAS_FORMATS
  • SINGLE DCI TYPES
  • SOURCE LOCATION CODE
  • STANDARDS AFFIL TYPE CODE
  • STUDY STATUS TYPE CODE
  • TMS_CONFIGURATION
  • TMS_OMISSIONASSIGNMENT
  • TMS_OMISSION_STATUS
  • TMS_QUERY_TYPE
  • TMS_X_SEARCH
  • TREAT CHG REASON TYPE CODE
  • UNITS_OF_MEASURE_TYPE_CODE
  • USER GROUP ROLES
  • USER GROUPS
  • VALIDATION FAILURE TYPE CODE
• Design Installation Reference Codelists
• System Reference Codelists

Part II Oracle Clinical Administration Tasks

8 Managing Batch Jobs

• User Account Requirements for Batch Jobs
• How PSUB Handles a Request
  • Asynchronous PSUB Requests
  • Blocking and Nonblocking Jobs
  • Checking a Nonblocking Batch Job
• Managing the PSUB Process
  • Starting and Stopping PSUB Manually in UNIX
    • Starting PSUB Manually in UNIX
    • Stopping PSUB Manually in UNIX
  • Starting and Stopping PSUB Automatically in UNIX
    • Starting PSUB Automatically in UNIX
    • Stopping PSUB Automatically in UNIX
  • Starting and Stopping PSUB Manually in Windows
    • Installing PSUB in Windows
    • Starting PSUB Manually in Windows
    • Stopping PSUB Manually in Windows
  • Starting PSUB Automatically in Windows
    • Creating a System Environment Variable
    • Creating a Batch File
    • Scheduling the Batch File and Testing the Setup
    • Adding a Shortcut
  • Changing PSUB Job Number Sequencing
  • Viewing the Status of a Submitted Batch Job
  • Removing the PSUB Service
  • Viewing Log and Output Files on the Screen
    • Viewing Logs That Concern Execution of Psub Processes
    • Viewing Logs for Individual PSUB Jobs
    • Printing Output or Log Files
  • Using Job Sets to Control Execution Order
    • Create a Job Set
    • Submit a Job Set
  • Tracking PSUB Processes
• Batch Job Reference Codelists

9 Partitioning and Indexing

• Introduction
  • Timing Considerations and Deferral of Index or Partition Upgrade
    • Enforcing Pre-Version 4.0 Optimization
  • About Partitioning
    • How Has the Responses Table Been Partitioned?
    • Why Partition?
• Planning for Partitioning Upgrade
  • Pre-upgrade Steps
    • Decide Partitions Needed
    • Define Partition Structure
    • Implement Partition Structure
    • Generating Table and Index Creation SQL
• Partitioning the Responses Table
  • Step 1. Back Up the Database
  • Step 2. Export the Responses Table
  • Step 3. Prepare the Database
    • Drop Responses Table
    • Reorganize Tablespaces and System File Space
    • Create Partitioned Responses Table
  • Step 4. Import Responses Data
  • Step 5. Compute Statistics on the Responses Table
  • Step 6. Create Indexes on Partitioned Responses Table
  • Step 7. Compile Invalid Objects and, Optionally, Restore Database Trigger
  • Step 8. Back Up the Database
  • Step 9. Regenerate Procedures and Data Extract Views
  • Step 10. Back Up the Database
  • Partition Maintenance
    • Prospective Allocation of clinical_study_ids for Partitioning
    • Strategy for Ongoing Partition Maintenance
    • Instructions for Partition Maintenance
    • Rebuild Indexes after Partition Maintenance
    • Using Read-Only Partitions to Minimize Backup
• Upgrading Indexes
  • Index Upgrade Process
  • Resizing the Storage Clause for Indexes
  • Response Index Upgrade
    • Regenerate Procedures and Data Extract Views
  • ResponsesT (Test Database) Index Upgrade
  • RECEIVED_DCI and RECEIVED_DCM Index Upgrades
• Query Tuning Guidelines

10 Utilities

• Computing the Validation Status of All Responses
  • Running cnvstatus on UNIX Platforms
  • Running cnvstatus on Windows
• Generating Validation Procedures
  • Running gen_procs on UNIX Systems
  • Running gen_procs on Windows Systems
• Deleting Inactive Procedures

11 Setting Up File Viewing

• File Viewing Setup Overview
• Editing formsweb.cfg to Change File Viewing Protocol
• Setting Directory Mappings
• Setting Up Image Viewing for DCI and DCM Form Layouts HTML Preview Feature

12 Enabling Image Viewing

• Setting Up a Central Image Repository
  • Setting Up a Network User to Run the Oracle Process Manager Service
  • Setting Up Image Viewing During Data Entry
• Copying Image Files to All Installations

Part III Appendixes

A Environment Variables and Registry Settings

• Summary of the Oracle Clinical Setup
  • Editing opa_settings.bat
  • Setting Up UNIX Environments
  • Changing Configuration Settings on UNIX Database Servers
    • Defaulting, Adding, and Customizing Values
    • Constraints on the opa_settings File
    • Checking for Errors in the opa_settings File
  • Changing Environment Variables on Windows
  • Settings that Affect Back-End Job Execution
    • NLS_DATE_FORMAT
    • NLS_LANG
    • RXC_BATCH_QUEUE
    • RXC_BDL_DIR
    • RXC_DEBUG_BUFFER_SIZE
    • RXC_IMMED_QUEUE
    • RXC_LOG
    • RXC_MAA_TAB_SPACE
    • RXC_NOW_STRING
    • RXC_PRINTER
    • RXC_SAS_BATCH_QUEUE
    • RXC_SAS_CONNECT
    • RXC_USER
    • SASORA
    • TEMP
    • USER_BV_JOB
• Windows Registry Settings
  • OPA Front End
  • Online Help
  • Oracle Clinical Front End
  • RDC Front End
  • OCN Front End
  • Report Server
  • Registry Keys
    • FORMS_PATH
    • OPA_JARS
    • OPA_XMLTEMP_UNC
    • OPA_XMLTEMP_HTTP
    • RDC_DCIF_IMAGES
    • OC_DE_FIELDFONT
    • OC_DE_TEXTFONT
    • RDC_PDF_PRINT_TOOL

B SAS_VIEW Directory Tree

C Troubleshooting

• Managing High Sequence Numbers
  • Assessing Sequence Sizes
  • Reseeding Sequences
• Error Messages
  • Message: ORA-12223
  • Message: ORA-04020
  • Message: Unable to Change Mode
• System Malfunction: GPF Occurs During Data Entry
  • Situation: $ulimit unlimited
• PSUB Jobs
  • Check the Failure Text in the Submitted Batch Jobs Window
  • Check the PSUB Log Files
  • If Batch Jobs Hang and the Batch Queue Is Full
    • Stopping Batch Jobs on UNIX Systems
    • Stopping Batch Jobs on Windows
  • Determining if PSUB is Running for a Database
    • What PSUB Processes are Running on a Given UNIX Server?
    • Is PSUB Running on a Given Windows Server?
  • Troubleshooting PSUB Based on the Batch Job's Execution Status
    • ENTERED
    • SUBMITTED
    • SUBMIT_FAILED
    • STARTED
    • FAILED
    • Other Items to Check
  • Handling PSUB Failures that Return "Fatal two-task communication protocol" Error
  • Handling PSUB Failure that Returns "Illegal use of PSLAUNCH..." Error
  • Tracking Previous PSUB Process Connections
• Database Trace

D Oracle Clinical Tablespaces

E Routine Server Administration

• Recreating Symbolic Links — UNIX Only
• Relinking Server Code — UNIX Only
• Relocating Oracle Clinical
• Updating Oracle Clinical Seed Data
• Collecting Statistics for Optimization

Glossary

Index