Go to main content
1/14
Contents
Title and Copyright Information
Preface
Audience
Documentation Accessibility
Finding Information and Patches on My Oracle Support
Finding Oracle Clinical Documentation
Related Documents
Conventions
1
Entering Data
1.1
Understanding the Data Entry Process
1.2
DCI Structure
1.3
Entering CRF Data in a DCI
1.3.1
Accessibility
1.3.2
Logging In CRF Header Information
1.3.2.1
Completing the Initial Log-In
1.3.2.2
If Your Header Information Fails to Validate
1.3.2.3
Completing the RDCM Window
1.3.2.4
Logging In DCMs
1.3.2.5
If You Cannot Complete All DCMs
1.3.3
First-Pass Data Entry
1.3.4
Initial Login and Data Entry
1.3.5
Validating Data Entry
1.3.5.1
Univariate Validation
1.3.5.2
System Responses to a Univariate Validation Failure
1.3.5.3
User Responses to a Univariate Validation Failure
1.3.5.4
Indicators of an Existing Discrepancy
1.3.5.5
Group and Form Validation
1.3.6
Second-Pass Data Entry
1.3.7
Reconciling Differences Between First- and Second-Pass Data
1.3.7.1
Resolving First-Pass/Second-Pass Comparison Failures
1.3.7.2
Resolving Duplicate or Missing Records
1.3.7.3
Performing Comparison Reconciliation
1.4
Making Adjustments During Data Entry
1.4.1
Enrolling a Patient
1.4.2
Transferring Patient Data
1.4.3
Handling Unplanned Events
1.4.4
Changing Tasks
1.4.5
Reviewing the DCI History
1.4.5.1
Audit Trail Window
1.4.5.2
How the System Stores the Audit Trail
1.5
Modifying DCIs
1.5.1
Process the Reason for Change Window
1.5.2
Changing Header Information
1.5.3
Updating Accessible Data
1.5.3.1
System Validations Performed During Update Mode
1.5.3.2
Performing a Privileged Update
1.5.4
Modifying or Deleting Locked RDCIs and RDCMs
1.5.4.1
To Modify Accessible RDCIs
1.5.4.2
To Delete Logged-in RDCIs
1.6
Viewing Data
1.6.1
Scanned Image
1.6.2
Browse
1.6.3
Browse the Audit Trail
2
Customizing Data Entry Windows
2.1
Sequencing Data Entry
2.1.1
Query Sequencing
2.1.2
DCI Book Sequencing
2.1.3
Using DCI Books
2.1.3.1
Completing DCIs from the DCI Book
2.1.3.1.1
Autosequencing Through DCI Books
2.1.3.1.2
Manually Stepping Through DCI Books
2.1.3.2
Patient Enrollment
2.1.4
Tracking Page-Level Information
2.1.4.1
Oracle Clinical Management of Unplanned DCIs
2.1.4.1.1
Unplanned Scenarios:
2.1.4.2
Applying Page Statuses
2.1.4.3
Tracking Changes to a Page
2.2
Navigation
2.2.1
Field Navigation
2.2.1.1
Normal Field Navigation
2.2.1.2
Auto Skip Navigation
2.2.1.3
Conditional Navigation
2.2.2
Other Navigation Features
2.2.2.1
Group Navigation
2.2.2.2
Display Received DCM Window
2.2.2.3
Exit/Autosequence Behavior
2.2.3
Comments Permitted in DCIs
2.2.3.1
Investigator Comments
2.2.3.2
Operator Comments
2.2.4
Physical Field Attributes
2.2.4.1
Color Indications on Data Entry Fields
2.2.4.2
Date and Time Field Formats
2.2.4.3
Using Long Fields
2.2.4.4
Modify Audit Comment
2.3
Value-Setting Features
2.3.1
Default Values
2.3.1.1
Single Default Values
2.3.1.2
Repeating Default Values
2.3.1.3
Second-Pass Sight Verification
2.3.2
Lists of Values
2.3.2.1
Insert/Delete Record in a Question Group
3
Tracking DCMs
3.1
About DCM Tracking
3.2
How Oracle Clinical Tracks DCMs
3.2.1
The Study Schedule
3.2.2
How Optional Visits Interact with DCM Tracking
3.2.3
How Termination Visits Interact With DCM Tracking
3.3
DCM Tracking Tools
3.3.1
Maintain Missing DCMs Window
3.3.2
DCM Detail Tracking Matrix Report
3.3.2.1
How to Use This Report
3.3.2.2
Report Parameters
3.3.2.3
Data Entry Statuses
3.3.2.4
RDCM Validation Statuses
3.3.2.5
Not-received DCM Statuses
3.3.3
Missing and Overdue DCMs Report
3.3.4
Investigator Corrections and Missing Pages Report
4
Using the Discrepancy Database
4.1
About the Discrepancy Database
4.2
Discrepancy Types
4.3
Example: Using Discrepancies to Clean Data
4.4
Using Batch Validation
4.4.1
Batch Validation Process
4.4.2
Locking Mechanism
4.4.3
Running Batch Validation
4.4.4
Running TMS Validation
4.4.5
Creating and Activating Resource Groups for Batch Validation
4.5
Executing a single Procedure
4.6
Using Profiles
4.6.1
Selecting a Profile
4.6.2
Refining Profile Criteria
4.6.3
Changing a Profile
4.6.3.1
Temporary Changes
4.6.3.2
Permanent Changes
4.6.4
Creating New Profiles
4.7
Using the Maintain Discrepancy Database Window
4.7.1
Single-Record View
4.7.2
Multi-Record View
4.7.3
Maintain Discrepancy Database Window Fields
4.7.4
Changing Discrepancy Display Layout and Filtering the Data Displayed
4.7.4.1
Changing the Display of Discrepancy Information
4.7.4.2
Filtering Discrepancy Information
4.7.4.3
Changing the Filter Values
4.7.4.4
Querying Within the Filter Limitations
4.7.5
Viewing Univariate Discrepancies' Related Discrepancies
4.7.6
Viewing Multivariate Discrepancies' Responses
4.7.7
Viewing a Discrepancy's History
4.7.8
Viewing a Discrepancy's Internal Comment History
4.8
Managing Discrepancies
4.8.1
Discrepancy Status Codes
4.8.1.1
System Status Code
4.8.1.2
Review Status Code
4.8.1.3
Resolution Status
4.8.1.4
Review Status Workflow Example
4.8.2
Browse and Update Patient Data
4.8.3
Entering Manual Discrepancies
4.8.4
Including CRF Page Numbers With Discrepancies
4.8.5
Maintaining Data Clarification Form (DCF) Information
4.8.6
Modifying Groups of Discrepancies
4.8.6.1
Selecting a Group of Records to Change
4.8.6.2
Choosing a Change Type
4.8.7
Group-Updating Review Status
4.8.8
Group-Updating CRF Page Numbers
4.8.9
Group-Inserting Standard Text
4.8.10
Group-Marking for Passive Review
4.8.11
Creating a DCF for a Hand-Selected Group of Discrepancies
4.9
Using the Test Discrepancy Database
5
Using Data Clarification Forms
5.1
Description of Fields
5.2
Creating DCFs
5.2.1
Adding Multivariate Discrepancy's Procedure Variables to a DCF
5.3
Adding, Removing, and Editing a DCF's Discrepancies
5.3.1
Adding a Discrepancy to a DCF
5.3.2
Removing a Discrepancy from a DCF
5.3.3
Editing Resolution and Comment Text
5.4
Viewing DCF Details
5.5
Maintaining DCF Discrepancy Query Details
5.6
Tracking DCF Pages
5.7
Setting the DCF Status
5.7.1
Changing the DCF Status from the Maintain DCFs Window
5.7.2
Changing the DCF Status When Printing the DCF Report
5.7.3
Changing the DCF Status by Changing DCF Page Statuses
5.8
Printing DCFs
5.8.1
DCF Print Status
5.8.2
About the Parameter New DCF Status to Assign
5.8.3
Troubleshooting: Unable to Print DCF
5.8.3.1
Checking Owning User Account Through Oracle Clinical User Interface
5.8.3.2
Checking Owning User Account Using SQL
5.9
Deleting DCFs
6
Making Mass Changes
6.1
About Mass Changes
6.2
Types of Mass Changes
6.3
Defining a Mass Change Specification and Its Criteria
6.3.1
Defining the Mass Change Specification
6.3.1.1
Naming and Describing the MCS
6.3.1.2
Defining the Scope of the Records to be Changed
6.3.1.3
Saving the Mass Change Specification
6.3.2
Defining Candidate Data Set Criteria
6.3.2.1
CDS Criteria Examples
6.3.2.2
CDS Criteria Syntax
6.3.2.3
CDS Criteria Definition Rules
6.3.2.4
Counting CDS Records
6.3.3
Copying a Mass Change Specification
6.4
Creating and Modifying the Candidate Data Set
6.4.1
Viewing the CDS
6.4.1.1
Rows
6.4.1.2
Columns
6.4.1.3
Status
6.4.2
Changing the Display and Processing Order
6.4.2.1
Example
6.4.2.2
To Reorder the Display and Processing Order:
6.4.3
Clearing a CDS
6.5
Correcting Records
6.5.1
Making Mass Changes: Group Updating
6.5.1.1
Specifying Group Update Changes
6.5.1.2
Excluding Records from the Group Update
6.5.1.3
Running the Group Update on the CDS
6.5.1.4
Testing that the Changes Are Valid
6.5.1.5
Printing a Report of the CDS Changes
6.5.1.6
Viewing Group Update Histories
6.5.1.7
Applying the Changes to the Database
6.5.1.8
Soft-Deleting RDCIs
6.5.2
Changing Individual Records in the CDS
6.6
Closing a Mass Change Specification
7
Batch Loading Data
7.1
Setting Up for Batch Data Loading
7.1.1
Defining a Rollback Segment
7.1.2
Defining and Using Format Masks
7.1.2.1
STANDARD Mask Format
7.1.2.2
User-Specified Formats
7.1.2.3
Normalized Lab Data
7.2
Batch Data Load Stages
7.2.1
Load
7.2.2
Prepare
7.2.3
Transfer
7.3
Standard Batch Data Load and Out of Study Batch Data Load
7.4
Using the Batch Data Loader
7.4.1
Preprocessing Data Files
7.4.1.1
Subevent Number Not Supplied
7.4.1.2
Loading Data into Derived Question Fields
7.4.2
Creating and Viewing Data File Entries
7.4.2.1
Creating Data File Entries for Out of Study Batch Data Loads
7.4.2.2
Creating Data File Entries for Standard Batch Data Loads
7.4.3
Selecting Data Files
7.4.4
Loading Data
7.5
Troubleshooting Batch Validation
7.5.1
Troubleshooting the Prepare Phase
7.5.2
Troubleshooting the Transfer Phase
7.6
Batch-Deleting Data
7.6.1
Auditing Data Deletion
7.6.1.1
Data File Tables
7.6.1.2
Data Tables
7.6.1.3
Definition Tables
7.6.1.4
Layout Tables
7.6.1.5
Other Reference Tables
7.6.2
Reports on Audited Data Deletion
7.7
Batch Data Load Reports
8
Data Extract
8.1
About Data Extract
8.2
Data Extract Context
8.2.1
Default View Creation Algorithm
8.2.2
View Types
8.2.3
Rollsnaps
8.2.4
Access Accounts
8.2.4.1
Purging Study Access Accounts
8.2.5
Table-Based Views
8.2.6
Creating Extract Tables and Indexes
8.3
Workflow
8.3.1
Submit Views to PSUB
8.3.1.1
Creating SAS Views on Windows when SAS and Oracle Clinical are on Different Computers
8.3.2
Creating SAS Views on UNIX when SAS and Oracle Clinical are on Different Computers
8.3.2.1
Run the SAS Job Manually
8.3.2.2
Run the SAS Job Automatically
8.3.2.3
Configure Reference Codelist Values
8.3.3
Full and Incremental Modes
8.3.4
Tasks in Conduct
8.3.5
Validation Status and Views
8.3.5.1
For Pre-3.1-Style Study Views
8.3.5.2
For View Builder Study Views
8.3.5.3
Rules for Setting Status Variables
8.3.5.3.1
O - Outstanding
8.3.5.3.2
I - Irresolvable
8.3.5.3.3
K - Confirmed
8.3.5.3.4
C - Clean
8.3.5.3.5
N - None
8.3.6
Create View Accounts
8.3.7
Query Data Extract Views
8.3.8
SAS Datasets
8.3.9
SAS Proc Reports
8.4
Data Extract View Loader
8.4.1
Loading External Views
8.4.2
File Format for Externally Loaded Views
8.4.2.1
Example 1: Oracle Format
8.4.2.2
Example 2: Oracle Format with Substitution Parameters
8.4.2.3
Example 3: SAS Format
8.4.3
Restrictions for Externally Loaded Views
8.4.4
Updating an Externally Loaded View
8.4.5
Deleting an Externally Loaded View
9
Security Settings for Study Conduct
9.1
Freezing and Locking Data
9.1.1
About Freezing and Locking Data
9.1.2
Freezing Data
9.1.2.1
Freezing Data by Site, Investigator, or Patients
9.1.2.2
Freezing Data by Study
9.1.3
Checking Frozen Status
9.1.4
Unfreezing Studies, Study Sites, Investigators, and Patients
9.1.4.1
Unfreezing Sites, Investigators, and Patients
9.1.4.2
Unfreezing a Study
9.1.5
Locking Data
9.1.5.1
Batch-Locking Data
9.1.5.2
Manually Locking RDCIs and RDCMs
9.2
Enabling and Disabling Pass 2 Required
9.3
Publish Source Data Verification Plans for All Sites
9.4
Execute Pending Patient Updates
10
Reports
10.1
Graphic Patient Data Report
10.1.1
Navigation and Format
10.1.2
Requirements
10.2
Patient Data Report Components
10.2.1
Page Numbering
10.2.2
Cover Page
10.2.2.1
Blank Workbook PDRs
10.2.2.2
Patient CRF PDRs
10.2.3
CRF Data Section
10.2.3.1
CRF Header Information
10.2.3.2
CRF Section Header Information
10.2.3.3
Response Data
10.2.4
Ancillary Data Section
10.2.4.1
CRF Creation
10.2.4.2
Approval Notice
10.2.4.3
End Notes
10.2.4.4
Extended Text
10.2.4.4.1
Extended Text Response Display
10.2.4.4.2
Extended Text Audit History Section
10.2.4.5
Deleted CRFs
10.3
Audit History Report
10.4
Verification and Approval History Report
Index
Scripting on this page enhances content navigation, but does not change the content in any way.