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Contents

Title and Copyright Information

Preface

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

Part I Configuration Tasks

1 Setting Up User Accounts

• 1.1 Creating an Administrator User Account
• 1.2 Running the Add User Script
  • 1.2.1 Granting Users Access to the ocpsub Account
  • 1.2.2 About the Add User Script
  • 1.2.3 Running the Add User Script
  • 1.2.4 Required Parameters
  • 1.2.5 Optional Parameters
• 1.3 Running the Migrate Users Script
• 1.4 Adding or Revoking OCPSUB Access
• 1.5 Maintaining Oracle User and Group User Accounts
  • 1.5.1 Adding a User to a Group User Account
• 1.6 Granting Data Access to User and Group User Accounts
  • 1.6.1 Granting Data Access to Programs and Projects
  • 1.6.2 Granting Data Access to a Study
  • 1.6.3 Superuser and Study Access Interaction
  • 1.6.4 Revoking User Access
• 1.7 Granting Data Access to RDC Users
  • 1.7.1 Granting Automatic Access in RDC to Studies Granted in Oracle Clinical
  • 1.7.2 Configuring Study and Site Security Privileges
  • 1.7.3 Changing the Default Access to DCIs
• 1.8 Granting Additional Database Roles to User Accounts
  • 1.8.1 Additional Database Roles for RDC Users
  • 1.8.2 Additional Database Roles for Oracle Clinical Users
• 1.9 Setting Up Data Extract Users
• 1.10 Setting Up PSUB Administrator Users
• 1.11 Setting Up Power Users
  • 1.11.1 UNIX
  • 1.11.2 Windows
• 1.12 Changing Passwords
  • 1.12.1 Changing the Password for a User
  • 1.12.2 Changing the Password for a Schema or Role Using the SET_PWD Utility
  • 1.12.3 Synchronizing Passwords in the WebLogic Admin Server
  • 1.12.4 Auditing Passwords
  • 1.12.5 Changing the Password for the OCPSUB or RXC_DISC_REP Account
• 1.13 Setting Password Requirements for User Accounts
  • 1.13.1 Default Behavior
  • 1.13.2 Creating a Profile
  • 1.13.3 Assigning a Profile to Users
  • 1.13.4 Getting More Information

2 Oracle Clinical Menu-Based Security

• 2.1 Predefined Database Roles
• 2.2 Creating and Modifying Database Roles
  • 2.2.1 Viewing Menu-Role Associations
    • 2.2.1.1 Organization of the Menu Module Tree
      • 2.2.1.1.1 Internal Menu Module Structure
      • 2.2.1.1.2 Role Association Structure
    • 2.2.1.2 Navigating the Menu Modules
  • 2.2.2 Modifying Menu-Role Associations
  • 2.2.3 Creating Custom Database Roles
    • 2.2.3.1 Creating Custom Roles for Restricting DCI Access
  • 2.2.4 Associating Roles with Menus
  • 2.2.5 Adding a Custom Role to OPA_MENU_ROLES
  • 2.2.6 Granting a Custom Role Access to a Custom Module
• 2.3 Adding Menu Items to Oracle Clinical

3 Configuring Discrepancy Management

• 3.1 Mapping Database Roles to User Roles
  • 3.1.1 Specifying User Roles for the Oracle Clinical Discrepancy Database
  • 3.1.2 Assigning Function Privileges and Layouts
    • 3.1.2.1 Assigning and Removing Function Privileges
    • 3.1.2.2 Assigning Custom Layouts
• 3.2 Customizing Layout Definitions
• 3.3 Customizing Profiles
  • 3.3.1 Toggling Between View Modes in the Profile Administration Window
  • 3.3.2 Specifying Default Profile Criteria
  • 3.3.3 Locking Profile Criteria
  • 3.3.4 Adding SQL Statements
  • 3.3.5 Filtering Profile Views by Review Status
  • 3.3.6 Updating Status Codes
  • 3.3.7 Filtering Profile Views by Discrepancy Field
    • 3.3.7.1 Adding Update Privileges by Review Status Code
    • 3.3.7.2 Setting Update Privileges by Discrepancy Field
    • 3.3.7.3 Setting Review Status Updating Privileges
• 3.4 Customizing Flexfields
  • 3.4.1 DISC_FLEX1 and DISC_FLEX2
  • 3.4.2 DISC_FLEX1_VALUES and DISC_FLEX2_VALUES
  • 3.4.3 Example
• 3.5 Defining Reason Codes for Discrepancies
  • 3.5.1 Reason Codes and Descriptions for Manual Discrepancies
  • 3.5.2 Reason Codes and Descriptions for Univariate Discrepancies
  • 3.5.3 Reason Codes and Descriptions for Multivariate Discrepancies
• 3.6 Defining the Possible Review Statuses for Discrepancies
  • 3.6.1 Default Entries for the DISCREPANCY REV STATUS CODE Codelist
  • 3.6.2 Rules for the DISCREPANCY REV STATUS CODE Codelist
• 3.7 Defining Resolution Reasons for Discrepancies
• 3.8 Setting Values in the OCL_STATE Local Reference Codelist
• 3.9 Configuring Role-Specific Discrepancy Management for RDC
  • 3.9.1 Configuring Discrepancy Display by User Role
    • 3.9.1.1 How RDC Indicates Discrepancies in the User Interface
    • 3.9.1.2 Rules for the DISCREPANCY STATUS role Codelists
    • 3.9.1.3 Comparison of the Default Values for the DISCREPANCY STATUS role Codelists
    • 3.9.1.4 DISCREPANCY STATUS CRA
    • 3.9.1.5 DISCREPANCY STATUS DM
    • 3.9.1.6 DISCREPANCY STATUS INV
    • 3.9.1.7 DISCREPANCY STATUS SITE
  • 3.9.2 Configuring the Actions Allowed on Discrepancies
    • 3.9.2.1 Rules for the DISCREPANCY ACTIONS role Codelists
    • 3.9.2.2 DISCREPANCY ACTIONS CRA
    • 3.9.2.3 DISCREPANCY ACTIONS DM
    • 3.9.2.4 DISCREPANCY ACTIONS INV
    • 3.9.2.5 DISCREPANCY ACTIONS SITE
  • 3.9.3 Preventing Update to OTHER Discrepancies
  • 3.9.4 Adding Reference Codelists for Custom Roles
• 3.10 Configuring Study and Site Security for Oracle Clinical Discrepancy Management
  • 3.10.1 Updating a Discrepancy
  • 3.10.2 Navigating to Data Entry
• 3.11 Setting Up Data Clarification Forms (DCFs)
  • 3.11.1 Defining DCF Statuses and their Behavior
  • 3.11.2 Laying Out the DCF
  • 3.11.3 Replacing the Placeholder DCF Logo Graphic
  • 3.11.4 Customizing and Upgrading DCF Reports
• 3.12 Creating Reusable Standard Text for Discrepancies and DCFs
  • 3.12.1 Creating New Standard Text
  • 3.12.2 Inserting Replacement Parameters
  • 3.12.3 Customizing Default Standard Text Entries

4 Configuring the Mass Changes Utility

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

5 Configuring Data Entry and User Preferences

• 5.1 Customizing Data Entry Behavior
  • 5.1.1 Define Data Entry Configuration Settings
    • 5.1.1.1 Configure Database-Level Data Entry Settings
    • 5.1.1.2 Configure Study-Level Data Entry Settings
    • 5.1.1.3 Configure User-Level Data Entry Settings
  • 5.1.2 Configuring Additional Data Entry User Preferences
  • 5.1.3 Configuring Privileged Update
    • 5.1.3.1 Set Privileged Update Using Configuration Settings
    • 5.1.3.2 Set Privileged Update Using Study/Site Security
• 5.2 Customizing the Oracle Clinical Log-in Window Layout
  • 5.2.1 Using the Log-in Layout Editor
  • 5.2.2 Modifying the Received DCI Window
  • 5.2.3 Modifying the Received DCM Window
  • 5.2.4 Modifying the Smart Received DCM Window
• 5.3 Scheduling a Job to Manage Patient Updates
• 5.4 Setting DCI Form Default Values for RDC Data Entry and Patient Data Reports
  • 5.4.1 Setting and Enforcing Values
  • 5.4.2 Settings
    • 5.4.2.1 DCI Form Definition
    • 5.4.2.2 DCI Form Runtime
    • 5.4.2.3 General
    • 5.4.2.4 Graphic Layout Editor/Updater
    • 5.4.2.5 Graphic Layout Generator - General
    • 5.4.2.6 Graphic Layout Generation - DCMS
    • 5.4.2.7 DCI Form Generation Defaults
    • 5.4.2.8 Default Settings for Showing DCM Header Fields
    • 5.4.2.9 Default DCM Header Field Prompts
    • 5.4.2.10 Version Migration
    • 5.4.2.11 Patient Data Report
    • 5.4.2.12 Validation
    • 5.4.2.13 Options in Group Verify dialog
    • 5.4.2.14 Options in Group Approve dialog
    • 5.4.2.15 Source Data Verification Plan
    • 5.4.2.16 Default DCI Custom Review Requirements
• 5.5 Configuring Custom Review Types
• 5.6 Customizing Flex Fields for DCI Forms
  • 5.6.1 How Flex Fields Work
  • 5.6.2 Flex Field Components
    • 5.6.2.1 Shipped Functions
• 5.7 Customizing Online Help
  • 5.7.1 Modifying Calls to Online Help Topic Files
  • 5.7.2 Copying Online Help Topic Files
  • 5.7.3 Placing Custom Help Files
• 5.8 Viewing Online Help Without Oracle Clinical

6 Configuring Data Extract

• 6.1 Adding the opapps User to the OCLSASCR User Group
• 6.2 Authenticating the SAS Connection
  • 6.2.1 Using Oracle Wallet for SAS Authentication
  • 6.2.2 Using SAS Encryption for SAS Authentication
• 6.3 Regenerating SAS Views Created in Pre-5.0 Oracle Clinical Releases
• 6.4 Creating SAS Output File Directories
• 6.5 Configuring Default Installation Data Extract Settings
• 6.6 Setting Values in Data Extract-Related Reference Codelists
• 6.7 Creating Tablespaces for Data Extract Tables and Indexes
  • 6.7.1 Creating Tablespaces
  • 6.7.2 Entering Tablespace Names in Reference Codelists
  • 6.7.3 Creating Data Extract Access Accounts Using Local Tablespaces
• 6.8 Customizing Data Extract Views
• 6.9 Generating Data Extract Views
  • 6.9.1 Running gen_views on UNIX Platforms
  • 6.9.2 Running gen_views on Windows
• 6.10 Enabling the View Builder and Converting Views
  • 6.10.1 Converting Views
  • 6.10.2 Enabling the View Builder in a Study
• 6.11 Controlling Access to Data Extract Views

7 Reference Codelists

• 7.1 Overview of Reference Codelists
  • 7.1.1 Working in the Maintain or Query Reference Codelists Windows
    • 7.1.1.1 Access
    • 7.1.1.2 Components
    • 7.1.1.3 Usage
      • 7.1.1.3.1 Query a reference codelist
      • 7.1.1.3.2 Navigate a list of codelists
      • 7.1.1.3.3 Add a value
  • 7.1.2 Adding a Value to a Reference Codelist
  • 7.1.3 Modifying a Value in a Reference Codelist
  • 7.1.4 Running the Reference Codelists Report
• 7.2 Local Reference Codelists
  • 7.2.1 BATCH QUEUE NAME Local Codelist
  • 7.2.2 DB_LINKS Local Codelist
  • 7.2.3 DCF COMMENT TEXT Local Codelist
  • 7.2.4 DCF DEFAULT FOOTERS Local Codelist
  • 7.2.5 DCF DEFAULT HEADERS Local Codelist
  • 7.2.6 DCF REPORT LABELS Local Codelist
  • 7.2.7 DISC COLS Local Codelist
  • 7.2.8 DISC_FLEX1 and DISC_FLEX2 Local Codelists
  • 7.2.9 DISC_FLEX1_VALUES and DISC_FLEX2_VALUES Local Codelists
  • 7.2.10 FLD RXCMCMCD RDCI DELETE Local Codelist
  • 7.2.11 FLD RXCMCMCD RDCI KEY Local Codelist
  • 7.2.12 FLD RXCMCMCD RDCM KEY Local Codelist
  • 7.2.13 FLD RXCMCMCD RESPONSE Local Codelist
  • 7.2.14 IND DISC COLS Local Codelist
  • 7.2.15 MAN DISC COLS Local Codelist
  • 7.2.16 MANHD DISC COLS Local Codelist
  • 7.2.17 MC CDS SORT ORDER Local Codelist
  • 7.2.18 MC COLUMNS Local Codelist
  • 7.2.19 MULTI DISC COLS Local Codelist
  • 7.2.20 NLS_CONFIG Local Codelist
  • 7.2.21 OCL_DE_CONFIG Local Codelist
    • 7.2.21.1 DVG List of Values STYLE
      • 7.2.21.1.1 SEQ
      • 7.2.21.1.2 SHORT
    • 7.2.21.2 COMMCHGREAS_REQ
    • 7.2.21.3 JUSTENTERP1TIME
    • 7.2.21.4 JUSTENTERP2TIME
    • 7.2.21.5 RSTRCT LCKD CRF
  • 7.2.22 OCL_DE_PREFS Local Codelist
  • 7.2.23 OCL_JOB_PREF Local Codelist
  • 7.2.24 OCL MC PREFS Local Codelist
  • 7.2.25 OCL_MENU_ACCESS Local Codelist
  • 7.2.26 OCL_STATE Local Codelist
    • 7.2.26.1 SAS_CONNECTION
    • 7.2.26.2 SERVER_OS
    • 7.2.26.3 LOCATION_CODE
    • 7.2.26.4 SERVER_NAME
    • 7.2.26.5 DB_BLOCK_SIZE
    • 7.2.26.6 TEMP_TABLES
    • 7.2.26.7 DM_PROMPT
    • 7.2.26.8 PROC_LAB_ALIAS
    • 7.2.26.9 DISC_DCM_PROMPT
    • 7.2.26.10 BOOK_ASSIGN
    • 7.2.26.11 TMS_FAIL_BV_ACT
    • 7.2.26.12 UPD_FV_INCREM
  • 7.2.27 PRINT QUEUE NAME Local Codelist
  • 7.2.28 PUBLIC_DB_LINKS Local Codelist
  • 7.2.29 RDC CONFIGURATION Role Local Codelists
  • 7.2.30 REPORT_SERVER Local Codelist
  • 7.2.31 SAS_QUEUE Local Codelist
  • 7.2.32 SQL FUNCTIONS Local Codelist
  • 7.2.33 TMS_DSI Local Codelist
  • 7.2.34 TMS_OPTIONS Local Codelist
  • 7.2.35 UNI DISC COLS Local Codelist
  • 7.2.36 WEB_DOCUMENT_CONFIG Local Codelist
  • 7.2.37 WEB_DOCUMENT_GROUPS Local Codelist
  • 7.2.38 PDR_FILE_NAMING Local Codelist
• 7.3 Installation Reference Codelists
  • 7.3.1 APPLICATION AREA CODE Installation Codelist
  • 7.3.2 APPLICATION SYSTEM NAME Installation Codelist
  • 7.3.3 APPROVE VERIFY RETAIN CODE Installation Codelist
  • 7.3.4 APPROVE VERIFY REVERSE CODE Installation Codelist
  • 7.3.5 BLIND TYPE CODE Installation Codelist
  • 7.3.6 CLINICAL PHASE Installation Codelist
  • 7.3.7 COUNTRIES Installation Codelist
  • 7.3.8 CRF PAGE NUMBERING SCHEME Installation Codelist
  • 7.3.9 CRF PAGE STATUS CODES Installation Codelist
  • 7.3.10 CRF PAGE STATUS QUERY Installation Codelist
  • 7.3.11 CUSTOM REVIEW TYPE Installation Codelist
  • 7.3.12 DATA CHANGE REASON TYPE CODE Installation Codelist
  • 7.3.13 DATA CHANGE REASON2 TYPE CODE Installation Codelist
  • 7.3.14 DCF LOCK CONDITIONS Installation Codelist
  • 7.3.15 DCF OPTIONAL STATUS CODES Installation Codelist
  • 7.3.16 DCF STATUS CODES Installation Codelist
  • 7.3.17 DCIF CHECKBOX SIZE Installation Codelist
  • 7.3.18 DCIF FONT TYPESIZE Installation Codelist
  • 7.3.19 DCIF PAGE DEFINITION Installation Codelist
  • 7.3.20 DCM DCI QG TYPE CODE Installation Codelist
  • 7.3.21 DISCREPANCY ACTIONS ROLE Installation Codelist
  • 7.3.22 DISCREPANCY MESSAGES Installation Codelist
  • 7.3.23 DISCREPANCY NO OTHER UPDATE Installation Codelist
  • 7.3.24 DISCREPANCY RESOLU TYPE CODE Installation Codelist
  • 7.3.25 DISCREPANCY REV STATUS CODE Installation Codelist
  • 7.3.26 DISCREPANCY STATUS ROLE Installation Codelists
  • 7.3.27 DISCRETE VAL GRP TYPE CODE Installation Codelist
  • 7.3.28 DISC_STDST_VALUES Installation Codelist
  • 7.3.29 DOSE FORM TYPE CODE Installation Codelist
  • 7.3.30 DOSE FREQUENCY TYPE CODE Installation Codelist
  • 7.3.31 DX_CONFIG Installation Codelist
  • 7.3.32 DX_EXTENDED_ATTRIBUTES Installation Codelist
  • 7.3.33 DX_INDEX_TABLESPACE Installation Codelist
  • 7.3.34 DX_KEY_NAME Installation Codelist
  • 7.3.35 DX_ROLES Installation Codelist
  • 7.3.36 DX_VIEW_TABLESPACE Installation Codelist
  • 7.3.37 EXP DESIGN TYPE CODE Installation Codelist
  • 7.3.38 EXTERNAL_TRANS_TYPE Installation Codelist
  • 7.3.39 LAB RANGE SUBSET CODE Installation Codelist
  • 7.3.40 MANUAL SOURCE TYPE CODE Installation Codelist
  • 7.3.41 MAPPING_TYPE Installation Codelist
  • 7.3.42 MEDICAL EVAL TYPE CODE Installation Codelist
  • 7.3.43 OBJECTIVE TYPE CODE Installation Codelist
  • 7.3.44 OCL_DOMAINS Installation Codelist
  • 7.3.45 OCL_INSTALLATION Installation Codelist
  • 7.3.46 OCL_OPTIONS_TYPE_CODE Installation Codelist
  • 7.3.47 OPA_MENU_ROLES Installation Codelist
  • 7.3.48 PATIENT STATUS CODE Installation Codelist
  • 7.3.49 PLAN STUDY INT TYPE CODE Installation Codelist
  • 7.3.50 PROCEDURE TYPE CODE Installation Codelist
  • 7.3.51 QUESTION CATEGORY TYPE CODE Installation Codelist
  • 7.3.52 RDCI CHANGE REASON TYPE CODE Installation Codelist
  • 7.3.53 RDCI CHANGE REASON2 TYPE CODE Installation Codelist
  • 7.3.54 REGION TYPE CODE Installation Codelist
  • 7.3.55 RETIREMENT REASON TYPE CODE Installation Codelist
  • 7.3.56 ROUTE OF ADMIN TYPE CODE Installation Codelist
  • 7.3.57 SAS_FORMATS Installation Codelist
  • 7.3.58 SINGLE DCI TYPES Installation Codelist
  • 7.3.59 SOURCE LOCATION CODE Installation Codelist
  • 7.3.60 STANDARDS AFFIL TYPE CODE Installation Codelist
  • 7.3.61 STUDY STATUS TYPE CODE Installation Codelist
  • 7.3.62 TMS_CONFIGURATION Installation Codelist
  • 7.3.63 TMS_LANGUAGES Installation Codelist
  • 7.3.64 TMS_QUERY_TYPE Installation Codelist
  • 7.3.65 TMS_SOURCE_MAT_VIEWS Installation Codelist
  • 7.3.66 TMS_TAL_POOL_CONFIGURATION Installation Codelist
  • 7.3.67 TMS_X_SEARCH Installation Codelist
  • 7.3.68 TREAT CHG REASON TYPE CODE Installation Codelist
  • 7.3.69 UNITS_OF_MEASURE_TYPE_CODE Installation Codelist
  • 7.3.70 USER GROUP ROLES Installation Codelist
  • 7.3.71 USER GROUPS Installation Codelist
  • 7.3.72 VALIDATION FAILURE TYPE CODE Installation Codelist
• 7.4 Design Installation Reference Codelists
• 7.5 System Reference Codelists

Part II Oracle Clinical Administration Tasks

8 Managing Batch Jobs

• 8.1 Account Requirements for Batch Jobs
• 8.2 How PSUB Handles a Request
  • 8.2.1 Asynchronous PSUB Requests
  • 8.2.2 Blocking and Nonblocking Jobs
  • 8.2.3 Checking a Nonblocking Batch Job
• 8.3 Securing PSUB
• 8.4 Using PSUB in a RAC Environment
• 8.5 Starting and Stopping PSUB
  • 8.5.1 Starting and Stopping PSUB Manually in UNIX
    • 8.5.1.1 Starting PSUB Manually in UNIX
    • 8.5.1.2 Stopping PSUB Manually in UNIX
  • 8.5.2 Starting and Stopping PSUB Automatically in UNIX
    • 8.5.2.1 Starting PSUB Automatically in UNIX
    • 8.5.2.2 Stopping PSUB Automatically in UNIX
  • 8.5.3 Starting and Stopping PSUB Manually in Windows
    • 8.5.3.1 Installing PSUB in Windows
    • 8.5.3.2 Starting PSUB Manually in Windows
    • 8.5.3.3 Stopping PSUB Manually in Windows
  • 8.5.4 Starting PSUB Automatically in Windows
    • 8.5.4.1 Creating a System Environment Variable
    • 8.5.4.2 Creating a Batch File
    • 8.5.4.3 Scheduling the Batch File and Testing the Setup
    • 8.5.4.4 Adding a Shortcut
• 8.6 Managing the PSUB Process
  • 8.6.1 Changing PSUB Job Number Sequencing
  • 8.6.2 Viewing the Status of a Submitted Batch Job
  • 8.6.3 Removing the PSUB Service
  • 8.6.4 Viewing Log and Output Files on the Screen
    • 8.6.4.1 Viewing Logs that Concern Execution of PSUB Processes
    • 8.6.4.2 Viewing Logs for Individual PSUB Jobs
    • 8.6.4.3 Printing Output or Log Files
  • 8.6.5 Using Job Sets to Control Execution Order
    • 8.6.5.1 Create a Job Set
    • 8.6.5.2 Submit a Job Set
  • 8.6.6 Tracking PSUB Processes
• 8.7 Required Reference Codelist Settings for Batch Jobs

9 Partitioning and Indexing

• 9.1 Introduction
  • 9.1.1 Timing Considerations and Deferral of Index or Partition Upgrade
    • 9.1.1.1 Enforcing Pre-Version 4.0 Optimization
  • 9.1.2 About Partitioning
    • 9.1.2.1 How Has the Responses Table Been Partitioned?
    • 9.1.2.2 Why Partition?
      • 9.1.2.2.1 Improves Database and System Management
      • 9.1.2.2.2 Removes Single Point of Failure
      • 9.1.2.2.3 Improves Performance
      • 9.1.2.2.4 Reduces Space Requirements
• 9.2 Planning for Partitioning
  • 9.2.1 Decide Partitions Needed
  • 9.2.2 Define Partition Structure
  • 9.2.3 Implement Partition Structure
  • 9.2.4 Generating Table and Index Creation SQL
• 9.3 Partitioning the Responses Table
  • 9.3.1 Step 1. Back Up the Database
  • 9.3.2 Step 2. Export the Responses Table
  • 9.3.3 Step 3. Prepare the Database
    • 9.3.3.1 Drop Responses Table
    • 9.3.3.2 Reorganize Tablespaces and System File Space
    • 9.3.3.3 Create Partitioned Responses Table
  • 9.3.4 Step 4. Import Responses Data
  • 9.3.5 Step 5. Compute Statistics on the Responses Table
  • 9.3.6 Step 6. Create Indexes on Partitioned Responses Table
  • 9.3.7 Step 7. Compile Invalid Objects and Restore Database Trigger
  • 9.3.8 Step 8. Back Up the Database
  • 9.3.9 Step 9. Regenerate Procedures and Data Extract Views
  • 9.3.10 Step 10. Back Up the Database
• 9.4 Partition Maintenance
  • 9.4.1 Prospective Allocation of clinical_study_ids for Partitioning
  • 9.4.2 Strategy for Ongoing Partition Maintenance
    • 9.4.2.1 Rebuild Partitions
    • 9.4.2.2 Managing New Studies
    • 9.4.2.3 Reviewing for Partitions that Need Splitting or Merging
    • 9.4.2.4 Maintenance of Cost-Based Statistics
  • 9.4.3 Instructions for Partition Maintenance
  • 9.4.4 Rebuild Indexes after Partition Maintenance
  • 9.4.5 Using Read-Only Partitions to Minimize Backup
• 9.5 Upgrading Indexes
  • 9.5.1 Index Upgrade Process
  • 9.5.2 Response Index Upgrade
    • 9.5.2.1 Regenerate Procedures and Data Extract Views
  • 9.5.3 ResponsesT (Test Database) Index Upgrade
  • 9.5.4 RECEIVED_DCI and RECEIVED_DCM Index Upgrades
• 9.6 Query Tuning Guidelines

10 Utilities

• 10.1 Computing the Validation Status of All Responses
  • 10.1.1 Running cnvstatus on UNIX
  • 10.1.2 Running cnvstatus on Windows
• 10.2 Generating Validation Procedures
  • 10.2.1 Running gen_procs on UNIX Systems
  • 10.2.2 Running gen_procs on Windows Systems
• 10.3 Deleting Inactive Procedures
• 10.4 Running Reports on Deleted Data and Discrepancies

11 Setting Up File and Image Viewing

• 11.1 Setting Up Batch Job File Viewing
  • 11.1.1 Setting Up Directories for PSUB
    • 11.1.1.1 Creating a Directory for Log and Output Files and Registering it in OCL_STATE
    • 11.1.1.2 Creating Directories for Input and Output Files of Certain Job Types
  • 11.1.2 Entering Reference Codelist Values
    • 11.1.2.1 Enter the Root Directory Path in OCL_STATE Local Reference Codelist
    • 11.1.2.2 Enter Y or N in the USERDIRS OCL_STATE Setting
• 11.2 Setting Up Image Viewing
  • 11.2.1 Put Images in dcif_images Directory
  • 11.2.2 Sharing the Images Directory
  • 11.2.3 Automatic Setup During Installation
  • 11.2.4 Changing the Images Directory Location

12 Setting Up Replication

• 12.1 Replication Concepts
  • 12.1.1 Locations in a Distributed Study Environment Installation
    • 12.1.1.1 Global Library-Owning Location
    • 12.1.1.2 Study-Owning Location
    • 12.1.1.3 Lab-Owning Location
  • 12.1.2 What Can You Replicate?
  • 12.1.3 What Methods of Replication Does Oracle Clinical Support?
    • 12.1.3.1 Standard Replication
    • 12.1.3.2 Disconnected Replication
    • 12.1.3.3 Symmetric Replication
    • 12.1.3.4 Comparison of Standard and Disconnected Replication
• 12.2 Prerequisites to Setting Up Replication
  • 12.2.1 Oracle Accounts for Replication
    • 12.2.1.1 RXA_READ Account
    • 12.2.1.2 RXC_REP Account
    • 12.2.1.3 RXC_DISC_REP Account
  • 12.2.2 Tables that Store Replication Information
  • 12.2.3 Seed Numbers for Databases Involved in Replication
• 12.3 Setting Up Replication-Related Reference Codelist Values
• 12.4 Setting Up the Database Links for Standard Replication
  • 12.4.1 Configuring the DB_LINKS Codelist for Standard Replication
  • 12.4.2 Configuring the PUBLIC_DB_LINKS Codelist for Standard Replication
  • 12.4.3 Creating the Private Database Links for the RXC_REP and RXA_DES Accounts
  • 12.4.4 Creating the Public Database Link for RXA_READ
• 12.5 Creating the Study Design Replication Packages
  • 12.5.1 Using the rxasrall.sql Script
    • 12.5.1.1 About Running the rxasrall.sql Script for Each Location
    • 12.5.1.2 Running the rxasrall.sql Script
  • 12.5.2 Creating the Views and Synonyms Required to Replicate Study Design
  • 12.5.3 Creating the Package for Replicating Investigators and Sites
• 12.6 Setting Up Symmetric Replication
  • 12.6.1 Setting Up Symmetric Replication
    • 12.6.1.1 Installing Symmetric Replication
    • 12.6.1.2 Running the Symmetric Replication Scripts Required for Oracle Clinical
    • 12.6.1.3 Verifying Data Is Replicating
  • 12.6.2 Enabling Symmetric Replication
  • 12.6.3 Reconciling Data
    • 12.6.3.1 Conflict Resolution
    • 12.6.3.2 Non-study-specific Tables Replicated
  • 12.6.4 Troubleshooting Symmetric Replication
    • 12.6.4.1 Problems During Installation of Symmetric Replication
    • 12.6.4.2 Problems During Routine Use of Symmetric Replication
    • 12.6.4.3 Problems after a Failure when Using Symmetric Replication

13 Using Replication

• 13.1 Example of an Oracle Clinical Distributed Study
• 13.2 Operating from the Study-Owning Location
  • 13.2.1 Changing Ownership and Replicating Patient Positions
    • 13.2.1.1 Changing the Ownership of Patient Positions
    • 13.2.1.2 Retrieving Patient Positions
  • 13.2.2 Maintaining Investigators and Sites
  • 13.2.3 Constraints at the Study-Owning Location
    • 13.2.3.1 Exceptions for Patient Positions
    • 13.2.3.2 Exceptions for Study Design Activities
  • 13.2.4 Replicating Data at a Study-Owning Location
• 13.3 Operating from a Sharing Location
  • 13.3.1 Study Design at a Sharing Location
  • 13.3.2 Study Definition at a Sharing Location
  • 13.3.3 Study Conduct at a Study-Sharing Location
  • 13.3.4 Data Replication at a Study-Sharing Location
  • 13.3.5 Replication of Labs and Lab Ranges at a Sharing Location
  • 13.3.6 Error if Flexible Study Setting Mismatch Between Locations
• 13.4 Enabling a Study for Replication
• 13.5 Using Standard Replication
  • 13.5.1 Review of Setting Up Standard Replication
  • 13.5.2 Replicating a Global Library
  • 13.5.3 Replicating Study Designs
    • 13.5.3.1 Replicating the Design of a Clinical Study
    • 13.5.3.2 Creating a Local Configuration for the Replicated Study
  • 13.5.4 Replicating a Study Definition
  • 13.5.5 Replicating Data
    • 13.5.5.1 What Does Oracle Clinical Include in Data Replication?
    • 13.5.5.2 Tracking the Execution of Data Replication
    • 13.5.5.3 Invoking Study Data Replication
    • 13.5.5.4 Managing Data at Multiple Locations
      • 13.5.5.4.1 Integrity
      • 13.5.5.4.2 Consistency
      • 13.5.5.4.3 Consistency and Data Extract
  • 13.5.6 Replicating Lab Information
    • 13.5.6.1 Replicating the Global Lab Information
    • 13.5.6.2 Replicating Labs and Lab Ranges
  • 13.5.7 Replication and Frequency
• 13.6 Using Disconnected Replication
  • 13.6.1 Overview of Disconnected Replication
    • 13.6.1.1 Users Who Can Run Disconnected Replication
    • 13.6.1.2 Disconnected Replication Uses Full Replication Only
    • 13.6.1.3 Advantages of Disconnected Replication
    • 13.6.1.4 Security Concerns with Disconnected Replication
    • 13.6.1.5 Example of How Disconnected Replication Is Used in Distributed Studies
  • 13.6.2 Extracting Source Data to an Export File
  • 13.6.3 Defining the Extract Data Parameters
    • 13.6.3.1 Target Location
    • 13.6.3.2 Include GLIB
    • 13.6.3.3 Include GLIB Labs
    • 13.6.3.4 Include Labs
    • 13.6.3.5 Study Code
    • 13.6.3.6 Extract Level
    • 13.6.3.7 Include Randomization
    • 13.6.3.8 Export File
  • 13.6.4 Loading Data from the Export File into a Target Location
    • 13.6.4.1 How Disconnected Replication Commits Data
• 13.7 Changing Study Ownership
• 13.8 Replicated Tables

Part III Appendixes

A Environment Variables and Registry Settings

• A.1 Oracle Clinical Setup Files
• A.2 Database Tier Settings
  • A.2.1 OPA Settings
    • A.2.1.1 NLS_DATE_FORMAT
    • A.2.1.2 NLS_LANG
    • A.2.1.3 RXC_BATCH_QUEUE
    • A.2.1.4 RXC_BDL_DIR
    • A.2.1.5 RXC_DEBUG_BUFFER_SIZE
    • A.2.1.6 RXC_IMMED_QUEUE
    • A.2.1.7 RXC_LOG
    • A.2.1.8 RXC_MAA_TAB_SPACE
    • A.2.1.9 RXC_NOW_STRING
    • A.2.1.10 RXC_PRINTER
    • A.2.1.11 RXC_SAS_BATCH_QUEUE
    • A.2.1.12 RXC_SAS_ROOT
    • A.2.1.13 RXC_SAS_VIEW
    • A.2.1.14 RXC_USER
    • A.2.1.15 SASORA
    • A.2.1.16 TEMP
    • A.2.1.17 USER_BV_JOB
  • A.2.2 Changing opa_settings on UNIX
    • A.2.2.1 Setting Up UNIX Environments
    • A.2.2.2 Changing Configuration Settings on UNIX Database Servers
      • A.2.2.2.1 Defaulting, Adding, and Customizing Values
      • A.2.2.2.2 Constraints on the opa_settings File
      • A.2.2.2.3 Checking for Errors in the opa_settings File
  • A.2.3 Setting TNS_ADMIN on UNIX
  • A.2.4 Changing opa_settings.bat on Windows
• A.3 Application Tier Settings
  • A.3.1 OPA Front End
  • A.3.2 Oracle Clinical Front End
  • A.3.3 RDC Front End
  • A.3.4 OCN Front End
  • A.3.5 Reports Server
  • A.3.6 Registry Keys
    • A.3.6.1 FORMS_PATH
    • A.3.6.2 OPA_JARS
    • A.3.6.3 OPA_XMLTEMP_UNC
    • A.3.6.4 OPA_XMLTEMP_HTTP
    • A.3.6.5 RDC_DCIF_IMAGES
    • A.3.6.6 OC_DE_FIELDFONT
    • A.3.6.7 OC_DE_TEXTFONT
    • A.3.6.8 RDC_PDF_PRINT_TOOL
  • A.3.7 Online Help
• A.4 Setting Environment Variables on the Command Line

B SAS_VIEW Directory Tree

C Troubleshooting

• C.1 Restart Application Server After Redeploying RDC Onsite
• C.2 Managing High Sequence Numbers
  • C.2.1 Assessing Sequence Sizes
    • C.2.1.1 Assess the Sequence Numbers of RDCMs, RDCIs, and Discrepancies
    • C.2.1.2 Assess the Sequence Number of Responses
  • C.2.2 Reseeding Sequences
• C.3 Error Messages
  • C.3.1 Message: Not Using Named Package
  • C.3.2 Message: ORA-12223
  • C.3.3 Message: ORA-04020
  • C.3.4 Message: Unable to Change Mode
  • C.3.5 Message: ConnectOCL - 970100
  • C.3.6 Message: PL/SQL Package Body: Looping Synonyms
• C.4 System Malfunction: GPF Occurs During Data Entry
• C.5 PSUB Jobs
  • C.5.1 Check the Failure Text in the Submitted Batch Jobs Window
  • C.5.2 Check the PSUB Log Files
  • C.5.3 If Batch Jobs Hang and the Batch Queue Is Full
    • C.5.3.1 Stopping Batch Jobs on UNIX Systems
      • C.5.3.1.1 Stopping an Individual Job
      • C.5.3.1.2 Stopping all Jobs
      • C.5.3.1.3 Administrator-level Troubleshooting
    • C.5.3.2 Stopping Batch Jobs on Windows
  • C.5.4 Determining if PSUB Is Running for a Database
    • C.5.4.1 What PSUB Processes Are Running on a Given UNIX Server?
    • C.5.4.2 Is PSUB Running on a Given Windows Server?
  • C.5.5 Troubleshooting PSUB Based on the Batch Job's Execution Status
    • C.5.5.1 ENTERED
    • C.5.5.2 SUBMITTED
    • C.5.5.3 SUBMIT_FAILED
    • C.5.5.4 STARTED
    • C.5.5.5 FAILED
    • C.5.5.6 Other Items to Check
  • C.5.6 Handling PSUB Failures that Return "Fatal two-task communication protocol" Error
  • C.5.7 Handling PSUB Failure that Returns "Illegal use of PSLAUNCH…" Error
    • C.5.7.1 Verify PSUB Account Uses C Shell
    • C.5.7.2 Modify launch.ps
  • C.5.8 Tracking Previous PSUB Process Connections
  • C.5.9 PSUB Fails to Start
  • C.5.10 PSUB Remains at Entered Status
  • C.5.11 Troubleshooting PSUB on a Windows Database
• C.6 Database Trace
• C.7 Problems in Reports
  • C.7.1 Truncated Field Display
  • C.7.2 Preview for Form Layout Editor or DCI Form Generation Fails on Standalone Reports Servers
  • C.7.3 Unable to Stop a Reports Job
  • C.7.4 PDR Fails with "Generating Cover Page" Error
• C.8 Error Accessing Web Services from Client

D Routine Server Administration

• D.1 Recreating Symbolic Links — UNIX Only
• D.2 Relinking Server Code — UNIX Only
• D.3 Relocating Oracle Clinical
• D.4 Updating Oracle Clinical Seed Data
• D.5 Collecting Statistics for Optimization
• D.6 Using Dynamic Sampling to Improve Batch Data Load Performance

E Oracle Clinical Tablespaces

Glossary

Index