Oracle Clinical is a data capture and validation system that allows for quick and easy data entry across globally distributed study sites. It supports single, double, and blinded double data entry. Any unexpected data is flagged as a discrepancy for later review. Discrepancies are tracked in tables like DISCREPANCY_ENTRIES and can be assigned to data clarification forms. The system also takes advantage of password protection and access controls for security.

1. DATA CAPTURE AND
VALIDATION
PRESENTER: PRIYA GEHLAWAT

2. 2
AGENDA
• DATA CAPTURE AND VALIDATION
• DE-NORMALIZING THE NORMALIZING STRUCTURE
• DISCREPANCY MANAGEMENT

3. 3
DATA CAPTURE AND VALIDATION
• OBTAINING "CLEAN" DATA IS FASTER AND SIMPLER WITH ORACLE
CLINICAL. THE ORACLE CLINICAL DATA ENTRY SYSTEM IS BOTH QUICK
AND EASY TO USE.
• GLOBALLY DISTRIBUTED DATA MANAGEMENT WITH ORACLE CLINICAL
MEANS:-
• THE SAME STUDY CAN BE PERFORMED AT SEVERAL LOCATIONS AROUND THE
WORLD WITH NO MORE EFFORT THAN CONDUCTING THE STUDY FROM A
SINGLE LOCATION.
• STUDY DEFINITIONS, INCLUDING AMENDMENTS, ARE AUTOMATICALLY
PROPAGATED TO ALL LOCATIONS WHICH ARE CONDUCTING THE STUDY.
• EACH LOCATION INDEPENDENTLY MANAGES ITS LOCAL STUDY SITES,
INCLUDING DATA VALIDATION AND CORRECTION. FURTHERMORE, DATA CAN
BE INCREMENTALLY REPLICATED TO ANY LOCATION FOR QUERY AND
ANALYSIS.

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DATA CAPTURE AND VALIDATION
• OC AS A DATA ENTRY TOOL
• THE SYSTEM SUPPORTS THREE MODES OF DATA ENTRY:
• SINGLE ENTRY
• DOUBLE ENTRY WITH ONLINE VERIFICATION, AND
• A BLIND DOUBLE ENTRY.
• THERE IS AN INTERACTIVE RECONCILIATION PROCESS FOR BLINDED
ENTRIES WHERE THE CONFLICTS ARE HIGHLIGHTED AND THE REVIEWER IS
GUIDED TO EACH QUESTION THAT NEEDS RECONCILIATION.

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DATA CAPTURE AND VALIDATION
• ORACLE CLINICAL TAKES ADVANTAGE OF MOST OPERATING SYSTEM’S
PASSWORD PROTECTION, AS WELL AS OF ORACLE8I AND ORACLE FORMS
SECURITY FEATURES IN ORDER TO CONTROL ACCESS TO THE APPLICATION ITSELF
AND TO VARIOUS MODULES WITHIN THE APPLICATION.
• ORACLE CLINICAL ALLOWS USERS TO CAPTURE ALL THE DATA AS RECORDED ON
THE CRF, THEN ADDS ITS OWN LEVEL OF SECURITY TO CONTROL THE ACCESS OF
INDIVIDUALS TO SPECIFIC STUDIES.
• ANY UNEXPECTED DATA (FOR EXAMPLE, THE VALUE “TRACE” IN A
NUMERICALLY DEFINED DATA FIELD) IS ACCEPTED AND TRACKED AS A
DISCREPANCY FOR LATER REVIEW.
• IT IS ALSO POSSIBLE TO CREATE MANUAL DISCREPANCIES AND ENTER
INVESTIGATOR COMMENTS, WHICH ARE TRACKED WITH ALL OTHER
DISCREPANCIES.
• IT IS ALSO POSSIBLE TO PRE-DEFINE “ALPHA DATA CODES”, WHICH ARE
ALLOWABLE CHARACTER VALUES IN NUMERIC OR DATE FIELDS.
• IF THE USER ENTERS ONE OF THESE ALPHA CODES, NO DISCREPANCY IS
CREATED. THIS ALLOWS FOR STANDARD PROCESSING OF DATA SUCH AS
“ND” (FOR NOT DONE) IN A NUMERIC FIELD OR “CONT” (FOR CONTINUING)
IN A DATE FIELD.

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DATA CAPTURE AND VALIDATION SUBSYSTEMS

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DATA CAPTURE AND VALIDATION-ENTRY OF DCM
DATA

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DATA CAPTURE AND VALIDATION-ENTRY OF DCM
DATA
• THE RESPONSES TABLE CONTAINS ALL THE RESPONSES TO ALL QUESTIONS IN ALL STUDIES
IN THE SYSTEM.
• RECEIVED_DCM_ID POINTS TO RECEIVED_DCMS WHICH PROVIDES THE STUDY, PATIENT
AND EVENT TO WHICH THE RESPONSE APPLIES. CLINICAL_STUDY_ID IMPROVES VIEW
PERFORMANCE.
• DCM_QUESTION_ID PROVIDES THE QUESTION TO WHICH THE RESPONSE WAS GIVEN VIA
THE DCM_QUESTIONS TABLE. DCM_QUESTION_GROUP_ID IS DE-NORMALIZED BUT
IMPROVES VIEW PERFORMANCE.
• REPEAT_SN GIVES THE REPEAT NUMBER IF A REPEATING QUESTION GROUP OR IS 1 IF A
NON-REPEATING GROUP.

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DATA CAPTURE AND VALIDATION-ENTRY OF DCM DATA
• DISCREPANCY_INDICATOR FLAGS IF THERE IS A DISCREPANCY ON THE RESPONSE.
• VALUE_TEXT CONTAINS THE RESPONSE TO THE QUESTION WHICH WILL CONVERT AS
DEFINED.
• EXCEPTION_VALUE_TEXT CONTAINS THE TEXT AS ENTERED IF THERE WOULD BE A
CONVERSION PROBLEM.

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• SECOND_PASS_INDICATOR SHOWS ENTRY STATUS OF THE DATA FOR INTERNAL USE OF
SYSTEM FOR AUDIT TRAILS AND REPORTS.
• VALIDATION_STATUS IS A THREE BYTE INDICATOR INDICATING FURTHER DISCREPANCY STATUS
INFORMATION
• DATA_CHANGE_REASON_TYPE_CODE HAS THE CODED REASON FOR THE CHANGE
• AUDIT_COMMENT_TEXT HAS FREE TEXT REASON FOR THE CHANGE
• DATA_COMMENT_TEXT IS ANY INVESTIGATOR COMMENT ENTERED FOR THE RESPONSE
DATA CAPTURE AND VALIDATION-ENTRY OF DCM DATA

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DE-NORMALIZING THE NORMALIZED STRUCTURE
• FOR REASONS OF BOTH DATA INTEGRITY AND PERFORMANCE, IT IS THE GOAL OF A
PRODUCTION DATABASE, TO REPRESENT EACH FACT OR DATA ITEM IN ONLY ONE
PLACE.
• THE DATA REDUNDANCY NOT ONLY CAUSES POTENTIAL ERRORS IN DATA
MAINTENANCE; IT ALSO REQUIRES ADDED STORAGE.
• NORMALIZATION IS THE TECHNICAL NAME FOR THE PROCESS THAT REVEALS AND
THEN ELIMINATES DATA REDUNDANCY. THE NORMALIZATION IN RDBMS IS A KEY
FACTOR OF A GOOD DATABASE DESIGN.
• THE NORMALIZED DATABASE IN THE RELATIONAL DATABASE SYSTEM GIVES
ADVANTAGES SUCH AS ELIMINATION OF REDUNDANCY, EASE OF USE, UPDATE, AND
MODIFICATION.
• EACH TABLE IN A NORMALIZED DATABASE HAS A PRIMARY KEY, WHICH IS A FIELD OR
FIELDS THAT UNIQUELY IDENTIFIES EACH RECORD IN THE TABLE.
• NORMALIZATION IS DONE BY MATCHING THE TABLES WITH FIRST, SECOND, AND THEN,
THIRD NORMAL FORM.

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• CDISC RECOMMENDS THAT THREE, (LABS, VITAL SIGNS AND ECG), OF THE STANDARD
SAFETY DOMAINS BE IN A NORMALIZED FORMAT FOR STATISTICAL ANALYSIS AS WELL
AS A DE-NORMALIZED, VITAL SIGNS AND ECG ONLY FORMAT FOR ONLINE REVIEW
USING CDISC ODM (OPERATIONAL DATA MODEL) XML.
DE-NORMALIZING THE NORMALIZED STRUCTURE

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DE-NORMALIZING THE NORMALIZED STRUCTURE
• EXTRACT VIEWS ARE GENERATED BY THE VIEW BUILDER AND DE-NORMALIZE
THE RESPONSE DATA RECORDED IN THE DCM
• THE ACTUAL EXTRACT VIEW IS MORE COMPLEX
• RESPONSES DOES NOT HAVE QUESTION NAME - ONLY A POINTER TO
DCM_QUESTIONS - AND MAY HAVE MULTIPLE VERSIONS FROM SELF AUDITING
• ACTUAL VIEW JOINS MULTIPLE TABLES
• RESPONSES
• RECEIVED_DCMS
• DCMS
• DCM_QUESTIONS
• DCM_QUESTION_GROUPS

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DISCREPANCY MANAGEMENT
• MAJOR TABLES FOR DISCREPANCY MANAGEMENT
• DISCREPANCY_ENTRIES
• DISCREPANCY_ENTRY_REVIEW_HISTORY
• VALIDATION_REPORTED_VALUES
• DATA_CLARIFICATION_FORMS
• DCF_DISCREPANCIES (V4.0 ONLY)

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DISCREPANCY MANAGEMENT

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DISCREPANCY MANAGEMENT

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DISCREPANCY MANAGEMENT
• WHEN WE ENTER INTO DISCREPANCY_ENTRIES DISCREPANCY IS CREATED BY ASSIGNING
DISCREPANCY_ENTRY_ID
• VALUES RELATED TO UNIVARIATE DISCREPANCIES ARE FOUND IN THE RESPONSES TABLE THROUGH
THE RECEIVED_DCM_ID AND REPOSNSE_ID
• PROCEDURES WHICH GENERATES A MULTIVARIATE DISCREPANCY ARE MARKED AS REPORTED IN THE
PROCEDURE AND IT IS LISTED IN THE VALIDATION_REPORTED_VALUES TABLES
• DCF_ID IN DISCREPANCY_ENTRIES INDICATES TO WHICH DCF THE DISCREPANCY IS ASSIGNED
A NULL VALUE FOR DCF_ID INDICATES DISCREPANCY IS NOT PART OF ANY DCF

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DISCREPANCY MANAGEMENT
 DISCREPANCY_ENTRY_REVIEW_HISTORY MAINTAINS AUDIT TRAIL OF CHANGES MADE
TO
DISCREPANCY COMMENTS AND REVIEW OR RESOLUTION STATUS FIELDS
 TABLE IS POPULATED BY A DATABASE TRIGGER
 ENHANCED DISCREPANCY MANAGEMENT SYSTEM IN VERSION 4.0 ALLOWS FOR
CREATION OF UP TO THREE COMMENTS WITH EACH DISCREPANCY
 THESE COMMENTS CAN BE CONFIGURED USING “STANDARD TEXTS” TO ALLOW
BETTER MESSAGES FOR ALL TYPES OF DISCREPANCIES
 DCFS WHICH ARE PART OF VERSION 4.0 ARE EASIER TO CREATE AND EDIT WITH RESPECT
TO THE DEFAULT TEXTS
 TEXTS FOR EACH DISCREPANCY IS STORED IN THE NEW DCF_DISCREPANCIES TABLE

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QUESTIONS
• DATA CAPTURE AND VALIDATION MEANS OBTAINING "CLEAN" DATA IS
FASTER AND SIMPLER WITH ORACLE CLINICAL. THE ORACLE CLINICAL
DATA ENTRY SYSTEM IS BOTH QUICK AND EASY TO USE. [TRUE / FALSE]
ANS = TRUE
• ORACLE CLINICAL TAKES ADVANTAGE OF MOST OPERATING SYSTEM’S
PASSWORD PROTECTION, AS WELL AS OF ORACLE8I AND ORACLE
FORMS [TRUE / FALSE] ANS = TRUE
• THE RESPONSES TABLE DO NOT CONTAINS ALL THE RESPONSES TO ALL
QUESTIONS IN ALL STUDIES IN THE SYSTEM. [TRUE / FALSE] ANS = FALSE
• VALIDATION_STATUS IS A THREE BYTE INDICATOR INDICATING FURTHER
DISCREPANCY STATUS INFORMATION [TRUE / FALSE] ANS = TRUE

20. THANK YOU