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Oracle® Clinical Conducting a Study
Release 5.0
E36997-01
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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
1
Entering Data
Understanding the Data Entry Process
DCI Structure
Entering CRF Data in a DCI
Accessibility
Logging In CRF Header Information
Completing the Initial Log-In
If Your Header Information Fails to Validate
Completing the RDCM Window
Logging In DCMs
If You Cannot Complete All DCMs
First-Pass Data Entry
Initial Login and Data Entry
Validating Data Entry
Univariate Validation
System Responses to a Univariate Validation Failure
User Responses to a Univariate Validation Failure
Indicators of an Existing Discrepancy
Group and Form Validation
Second-Pass Data Entry
Reconciling Differences Between First- and Second-Pass Data
Resolving First-Pass/Second-Pass Comparison Failures
Resolving Duplicate or Missing Records
Performing Comparison Reconciliation
Making Adjustments During Data Entry
Enrolling a Patient
Transferring Patient Data
Handling Unplanned Events
Changing Tasks
Reviewing the DCI History
Audit Trail Window
How the System Stores the Audit Trail
Modifying DCIs
Process the Reason for Change Window
Changing Header Information
Updating Accessible Data
System Validations Performed During Update Mode
Performing a Privileged Update
Modifying or Deleting Locked RDCIs and RDCMs
To Modify Accessible RDCIs
To Delete Logged-in RDCIs
Viewing Data
Scanned Image
Browse
Browse the Audit Trail
2
Customizing Data Entry Windows
Sequencing Data Entry
Query Sequencing
DCI Book Sequencing
Using DCI Books
Completing DCIs from the DCI Book
Patient Enrollment
Tracking Page-Level Information
Oracle Clinical Management of Unplanned DCIs
Applying Page Statuses
Tracking Changes to a Page
Navigation
Field Navigation
Normal Field Navigation
Auto Skip Navigation
Conditional Navigation
Other Navigation Features
Group Navigation
Display Received DCM Window
Exit/Autosequence Behavior
Comments Permitted in DCIs
Investigator Comments
Operator Comments
Physical Field Attributes
Color Indications on Data Entry Fields
Date and Time Field Formats
Using Long Fields
Modify Audit Comment
Value-Setting Features
Default Values
Single Default Values
Repeating Default Values
Second-Pass Sight Verification
Lists of Values
Insert/Delete Record in a Question Group
3
Tracking DCMs
About DCM Tracking
How Oracle Clinical Tracks DCMs
The Study Schedule
How Optional Visits Interact with DCM Tracking
How Termination Visits Interact With DCM Tracking
DCM Tracking Tools
Maintain Missing DCMs Window
DCM Detail Tracking Matrix Report
How to Use This Report
Report Parameters
Data Entry Statuses
RDCM Validation Statuses
Not-received DCM Statuses
Missing and Overdue DCMs Report
Investigator Corrections and Missing Pages Report
4
Using the Discrepancy Database
About the Discrepancy Database
Discrepancy Types
Example: Using Discrepancies to Clean Data
Using Batch Validation
Batch Validation Process
Locking Mechanism
Running Batch Validation
Running TMS Validation
Creating and Activating Resource Groups for Batch Validation
Executing a single Procedure
Using Profiles
Selecting a Profile
Refining Profile Criteria
Changing a Profile
Temporary Changes
Permanent Changes
Creating New Profiles
Using the Maintain Discrepancy Database Window
Single-Record View
Multi-Record View
Maintain Discrepancy Database Window Fields
Changing Discrepancy Display Layout and Filtering the Data Displayed
Changing the Display of Discrepancy Information
Filtering Discrepancy Information
Changing the Filter Values
Querying Within the Filter Limitations
Viewing Univariate Discrepancies' Related Discrepancies
Viewing Multivariate Discrepancies' Responses
Viewing a Discrepancy's History
Viewing a Discrepancy's Internal Comment History
Managing Discrepancies
Discrepancy Status Codes
System Status Code
Review Status Code
Resolution Status
Review Status Workflow Example
Browse and Update Patient Data
Entering Manual Discrepancies
Including CRF Page Numbers With Discrepancies
Maintaining Data Clarification Form (DCF) Information
Modifying Groups of Discrepancies
Selecting a Group of Records to Change
Choosing a Change Type
Group-Updating Review Status
Group-Updating CRF Page Numbers
Group-Inserting Standard Text
Group-Marking for Passive Review
Creating a DCF for a Hand-Selected Group of Discrepancies
Using the Test Discrepancy Database
5
Using Data Clarification Forms
Description of Fields
Creating DCFs
Adding Multivariate Discrepancy's Procedure Variables to a DCF
Adding, Removing, and Editing a DCF's Discrepancies
Adding a Discrepancy to a DCF
Removing a Discrepancy from a DCF
Editing Resolution and Comment Text
Viewing DCF Details
Maintaining DCF Discrepancy Query Details
Tracking DCF Pages
Setting the DCF Status
Changing the DCF Status from the Maintain DCFs Window
Changing the DCF Status When Printing the DCF Report
Changing the DCF Status by Changing DCF Page Statuses
Printing DCFs
DCF Print Status
About the Parameter New DCF Status to Assign
Troubleshooting: Unable to Print DCF
Checking Owning User Account Through Oracle Clinical User Interface
Checking Owning User Account Using SQL
Deleting DCFs
6
Making Mass Changes
About Mass Changes
Types of Mass Changes
Defining a Mass Change Specification and Its Criteria
Defining the Mass Change Specification
Naming and Describing the MCS
Defining the Scope of the Records to be Changed
Saving the Mass Change Specification
Defining Candidate Data Set Criteria
CDS Criteria Examples
CDS Criteria Syntax
CDS Criteria Definition Rules
Counting CDS Records
Copying a Mass Change Specification
Creating and Modifying the Candidate Data Set
Viewing the CDS
Rows
Columns
Status
Changing the Display and Processing Order
Example
To Reorder the Display and Processing Order:
Clearing a CDS
Correcting Records
Making Mass Changes: Group Updating
Specifying Group Update Changes
Excluding Records from the Group Update
Running the Group Update on the CDS
Testing that the Changes Are Valid
Printing a Report of the CDS Changes
Viewing Group Update Histories
Applying the Changes to the Database
Soft-Deleting RDCIs
Changing Individual Records in the CDS
Closing a Mass Change Specification
7
Batch Loading Data
Setting Up for Batch Data Loading
Defining a Rollback Segment
Defining and Using Format Masks
STANDARD Mask Format
User-Specified Formats
Normalized Lab Data
Batch Data Load Stages
Load
Prepare
Transfer
Standard Batch Data Load and Out of Study Batch Data Load
Using the Batch Data Loader
Preprocessing Data Files
Subevent Number Not Supplied
Creating and Viewing Data File Entries
Creating Data File Entries for Out of Study Batch Data Loads
Creating Data File Entries for Standard Batch Data Loads
Selecting Data Files
Loading Data
Understanding the Error Log
Batch Deleting Data
Auditing Data Deletion
Batch Data Load Reports
Processed Data Report
8
Data Extract
About Data Extract
Data Extract Context
Default View Creation Algorithm
View Types
Rollsnaps
Access Accounts
Purging Study Access Accounts
Table-Based Views
Creating Extract Tables and Indexes
Workflow
Submit Views to PSUB
Creating SAS Views on Windows when SAS and Oracle Clinical are on Different Computers
Full and Incremental Modes
Tasks in Conduct
Validation Status and Views
For Pre-3.1-Style Study Views
For View Builder Study Views
Rules for Setting Status Variables
Create View Accounts
Query Data Extract Views
SAS Datasets
SAS Proc Reports
Data Extract View Loader
Loading External Views
File Format for Externally Loaded Views
Example 1: Oracle Format
Example 2: Oracle Format with Substitution Parameters
Example 3: SAS Format
Restrictions for Externally Loaded Views
Updating an Externally Loaded View
Deleting an Externally Loaded View
9
Security Settings for Study Conduct
Freezing and Locking Data
About Freezing and Locking Data
Freezing Data
Freezing Data by Site, Investigator, or Patients
Freezing Data by Study
Checking Frozen Status
Unfreezing Studies, Study Sites, Investigators, and Patients
Unfreezing Sites, Investigators, and Patients
Unfreezing a Study
Locking Data
Batch-Locking Data
Manually Locking RDCIs and RDCMs
Enabling and Disabling Pass 2 Required
10
Graphic Patient Data Reports
Graphic Patient Data Report
Navigation and Format
Requirements
Patient Data Report Components
Page Numbering
Cover Page
Blank Workbook PDRs
Patient CRF PDRs
CRF Data Section
CRF Header Information
CRF Section Header Information
Response Data
Ancillary Data Section
CRF Creation
Approval Notice
End Notes
Extended Text
Deleted CRFs
Audit History Report
Index