Clinical Data Management-I Unit 6

Unit 6 Discrepancy Management

STRUCTURE

6.1 Introduction
Objectives
6.2 OVERVIEW OF DISCREPANCY MANAGEMENT
6.3 DATA VALIDATION PLAN
6.3.1 BATCH VALIDATION
6.3.2 STUDY VALIDATION PLAN/EDIT CHECK
6.3.3 UNIVERSAL RULING
6.4 DISCREPANCIES
6.4.1 HOW TO ACCESS THE DISCREPANCIES
6.4.2 IDENTIFYING THE PATIENTS FOR REVIEWING
6.4.3 Types of Discrepancies
6.5 DISCREPANCY REVIEW AND RESOLUTION STATUS CODES
6.6 AUDIT TRAIL
6.7 DATA CLARIFICATION FORMS
SELF ASSESSMENT QUESTIONS
6.8 Summary
6.9 Terminal Questions
6.10 Answers to SAQ and TQ
6.11 ABBREVIATIONS

6.1 Introduction
This unit essentially deals with various aspects of Discrepancy
Management. Various topics of discrepancy management like Data
Validation plan, discrepancies, discrepancy review and resolution status
codes are discussed.

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Objectives

After studying this unit, you should be able to:

• Define Discrepancy Management

• Describe the process involved in Data Validation Plan
• Describe the type of Discrepancies
• Define Data Clarification Form

Nouns

C ountable Uncountable

P roper Common Abstract Collective

Noun Noun Noun Noun

6.2 Overview of Discrepancy Management

Discrepancy Management is a critical part of Data Management. It plays an

important role in cleaning and submitting the data for final study analysis in
a clinical trial. A discrepancy can be defined as a message flagged/stamped
either manually or programmed check following the batch validation process
if the response to a question is invalid or the data recorded is unacceptable.
Verbs can be TRANSITIVE or INTRANSITIVE.
i) In ‘transitive’ the action passes from the subject to an object.

E.g.: My cat killed a rat.

My cat killed a rat

The action of “killing” is passed from the

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‘cat’ to the ‘rat.’ Here ‘killed’ is a transitive verb.

6.3 Data Validation Plan
Data Validation Plan plays a key role in discrepancy management. It
involves:
 Batch Validation
 Study Validation Plan/Edit Check
 Universal Ruling

6.3.1 Batch Validation:

Batch Validation are programmed checks by Clinical Data Management
System (CDMS) to assure the validity and accuracy of the data.

Subject: The complete subject is the simple subject (a noun or a pronoun)

plus any words or group of words modifying the simple subject that tell
who or what the sentence is about. Thus, a subject is the person, place, or
thing that acts, is acted on, or is described in the sentence.

Christopher Columbus discovered America

Subject Verb

The action of the sentence is expressed by the verb - ‘discovered.’

The noun ‘Christopher Columbus’ is doing the action of discovering.
Hence, ‘Christopher Columbus’ is the Subject in the sentence.
Sometimes the verb will express ‘being’ or ‘existence’ instead of action
It validates data against predetermined specifications and is primarily used
to check the efficacy data unique to the current study.

6.3.2 Study Validation Plan/Edit Check:

Study Validation Plan is a document which records the edit checks for a
study in order to maintain consistency and validity of the data.

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1. Preposition of time: on, in, at, for, before, after, until, till, between, by,
upto.
E.g.: She was healthy till yesterday.
2. Preposition of place: to, at, from, away, on, onto, of, in, into, out, upon,
inside, within, by, over, above, on top of, behind, in front of, below,
beneath, across, through, all over, throughout, between, among.
E.g.: Where do you come from?
3. Preposition of method and manner: by, with
E.g.: The boys skipped going to school with audacity.
4. Preposition of reason and purpose: with, of, for,
E.g.: I rented a house for my holidays
5. Preposition of possession: of, with, by
E.g.: The tomb of Akbar is in Sikandarabad.

The document is normally reviewed by Database Programmer, Project Data

Manager, Biostatistician, Clinical Team Lead.

The edit check document may be modified depending upon the sponsor’s
requirement during the study. The final version of the document after
incorporation of the changes, if any, during the study, is approved before the
database lock. Comments are incorporated into the Draft version and
programming of the checks commence after sponsor approval. The checks
are put into production after validation.

Examples:
1. Inclusion Criteria- The subject should be of the age range 18-25 years.
An edit check will be written in the document and programmed for
subjects, whose age is not within the range 18-25 years.

A discrepancy will fire in the database for which a Data Clarification

Form (DCF) shall be sent.

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Some of the edit checks are repetitive in nature and hence can be
combined as per the event while programming. Generally, there are
around 100-250 checks, which can be written and programmed for a
study based on the number of pages and data points.
2. Please find below an example of an Edit Check document. The
document consists of edit checks for Demography Page and
Concomitant Medication Page. It briefly explains as to how the
document should appear.

CRF Check
Chec CRF Specifi DCF/QueryDiscrepanc Procedure Acti
Page Descriptio
k No. Item c visit text y logic Name on
# n

Birth date
is missing. Birth
Birth Screeni Birth date Please date DM_BLANK_
1 1 DCF
date ng is missing provide the should be 01
correct provided.
date.
Sex is
Response
missing.
Screeni Sex is for sex DM_BLANK_
2 Sex 1 Please DCF
ng missing should be 02
provide the
provided.
sex.(M/F)
Race is
Response
missing.
Screeni Race is for Race DM_BLANK_
3 Race 1 Please DCF
ng missing should be 03
provide the
provided.
race.
Name of
the
Name of If Name
Medication
the of the
( ) is
medication Medicatio
provided,
is n is
Start 5 and Screeni however CR_BLANK_0
4 provided, provided, DCF
date 6 ng the start 1
however Start
date is
the start date
missing.
date is should be
Please
missing. provided.
provide the
date.
5 End 5 and Screeni Name of Name of If Name CR_BLANK_0 DCF
date/ 6 ng the the of the 2
Ongoin medication Medication medicatio
g is ( ) is n is
provided, provided, provided,
however however the End
the End the End date
date and date/Ongoi /Ongoing

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ng is
missing.
Ongoing is should be
Please
missing. provided.
provide the
data.

Figure 6.1

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6.3.3 Universal Ruling:

A Universal Ruling can be defined as a document, which allows the
authorized Data Management staff to make self-evident corrections to the
CRF and/or database without issuing a Data Clarification Form (DCF).

Example:
For an indicator question, the response is missing, however, data is
provided on the CRF for the question.
Action: Check the [ ] Yes [ ] No

Universal ruling is referred to by different names as per preference such as

Global Ruling, self evident correction document etc. However, they all refer
to the same document, Universal Ruling.

6.4 Discrepancies
6.4.1 How to access the Discrepancies:
CDMS Process Flow

Identify Patient (s) for Review

Identify Discrepancies

Review Discrepancies against Database and Case Report Form

Change Discrepancy Status

Create Data Clarification Forms

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Print Data Clarification Forms

Update the Database

6.4.2 Identifying the Patients for Reviewing:

 Patients for whom discrepancies need to be reviewed can be identified
in a number of ways based on present study needs.
 All patients with unreviewed discrepancies.
 Patients for a specific site with unreviewed discrepancies.
 Patients with unreviewed discrepancies created during a certain time
period.

6.4.3 Types of Discrepancies

A discrepancy is a variance between actual and expected responses as
defined in the Data Validation Document. When data fails a validation check,
the system generates and records a discrepancy in the CDMS.

There are four types of discrepancies, which are generated in CDMS, which
is system specific:
 Univariate
 Multivariate
 Manual
 Indicator

Univariate Discrepancy:
Univariate discrepancy is generated when data is different from that defined
for the Data Collection Module (DCM) question (e.g., length or character in a
numeric field). Created during data entry, update or batch data load.
Univariate failure is errors that occur when data entered fail the predefined

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field parameters. A univariate error is system generated, and applies to only

one field.

Relative Pronouns: They are used for the nouns (antecedents) used
before them. They are used in the following:

0.0.1.1.1.1.1.1.1 Subject Object Possessive

For persons who, that whom/who, that whose
For things which, that which/that whose/of which

• A relative pronoun must always be placed as near its antecedent as

possible. It must also agree with its antecedent in number, gender and
person
E.g.: This is the woman who stole the ring.
(ant.) (re. pro)
• Generally, the relative pronoun in the objective case is omitted.
E.g.: The student (whom) you wanted to punish is absent today.

When the cursor is leaving a response field, the system validates the data
entered based, on the following criteria:
 Mandatory value is entered
 Length
 Decimal precision
 Data type (character vs number)
 Dates are complete
 Value is valid within a discrete value group, if applicable
 Value is within predetermined range

Multivariate Discrepancy:

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Multivariate discrepancy is generated during Batch Validation when data

points are compared within/across visits does not meet criteria for a
validation procedure.
Example;
Did the subject take the pills? [ ] Yes [ ] No

If yes, mention the number of pills taken_ __

Discrepancy message: No pills were taken, however the number of pills

taken is reported as ‘2’. Please check.

Manual Discrepancy:
Any word that adds more meaning to the Noun is called an Adjective. It
qualifies a noun. Eg.: Ankur is a good player. The baby drank a little milk.
Correct Use of some adjectives:
a) Little (practically no chance) Deepak has little chance of being
elected.
A little (some chance) There is a little hope of his
success.
The little (whatever available) I shall give him the little money I
have.
b) Few (practically none) Few people are good.
A few (a small number) I have a few friends in my office.
The few (whatever available) I will pack the few things I have.
c) First (first in order) Yuri Gagarin was the first man to
go into space.
Foremost (leading, eminent) Einstein was the foremost scientist
of his day.

Indicator Discrepancy:

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Indicator Discrepancy is a check for a response to a question, which

determines a set of the remaining questions that require responses.

If a follow-up question is either not collected when it should be, or collected

when it should not be, Clinical Data Management System (CDMS) creates
an indicator discrepancy during batch validation.
Example:
A) Did the subject take the pills? [ ] Yes [ ] No
If Yes, mention the number of pills taken _______
If No, check whether the subject is out of the study.

6.5 Discrepancy Review and Resolution Status Codes

Please find below list of Discrepancy Review Status, Discrepancy
Resolution Status, and Definition which can be viewed in Clinical Data
Management System (system specific).

Discrepancy Discrepancy Definition

Review Resolution status
status
Inv Review A discrepancy that is issued to a site
per DCF.
Resolved Global/Universal Ruling To be used when a data change is
made per Global/Universal Ruling and
the discrepancy is no longer valid.
Resolved Data Entry Error To be used when a data change is
made to fix a data entry error and the
discrepancy is no longer valid.
Resolved No Action Required For any discrepancy that is valid, yet
information is present on the CRF
indicating the data is correct and a
DCF should not be sent to the site.
Resolved Data Modified For a discrepancy attached to a DCF
where the data was updated and the
discrepancy is no longer valid.
Resolved Inv Confirmed For a discrepancy attached to a DCF

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where the data was confirmed and no

updated were made.
Resolved Inv-No Information To be used when a response on a
DCF is not sufficient to close the
discrepancy and the discrepancy is
reissued on a new DCF.
Passive A discrepancy that depends on the
Review resolution of a different discrepancy
for which a DCF is sent. This
discrepancy is linked to the same
DCF, but is not sent to the site.
On Hold A discrepancy that we are waiting for
more information to process, e.g. a
question is out to the client, waiting for
another CRF page to come in.

Irresolvable* Inv-No Information To be used when a DCF with this

discrepancy is never returned from the
site and no changes are made to the
database.
Unreviewed A discrepancy that has not been
addressed by a CDC. This is the
initial status of all discrepancies.

6.6 Audit Trail

The documentation that tracks the changes that have been made to
recorded data (e.g., case report forms) and/or databases. It is particularly
useful for reviewing the history of changes to data in a study.

INV CORR Update made per DCF

UNIVERSAL/GLOBAL RULING Update made per Universal/Global Ruling
DATA ENTRY ERR Update made because of a DE error
CRA CORR Update made per site-DCF
SPONSOR CORR Updates made at the request of the
sponsor without issuing a DCF

6.7 Data Clarification Forms

Data Clarification Forms are queries, which are written to investigators for
clarifications, missing data etc. Edit check form the basis for writing a query.

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The query text is written using discrepancies in the discrepancy module. An

automated process of CDMS generates a form called Data Clarification
Form, containing the queries.

The DCFs are sent to the investigators on which they provide clarifications
on the form, sign with the date and send it back. These responses are
updated to the database appropriately.

Data Clarification Forms consist of:

 Study Name
 Investigator Name
 Site/Patient ID
 Patient Initials
 Reviewer
 Date: (Reviewer Date)
 From (Clinical Research Organization (CRO) from where the Data
Clarification Form is generated).
 Form Name/Visit Name
 Page Number/Date
 Question/Comments
 Resolution
 Investigator’s Signature
 Date (Investigator signature date)
 DCF ID

Few Examples of Data Clarification Forms (DCFs) are as follows:

Example 1
On Medical History Page (), the response for Date of Birth is missing.
Please provide the missing response.

Example 2

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On Concommitant Medication Page (), the response for "Is the subject
currently taking medications" is yes. However, the data is missing. Please
clarify.

Example 3
On Vital Signs Page (), the response for value of Diastolic Blood Pressure is
not within the normal range of 040 – 100 mmHg. Please provide the value
within 040-100 mmHg.

Example 4
On Laboratory page (), the response for "Are there any positive results?" is
No. However ‘specify’ is provided. Please Clarify.

Example 5
On Chest X-ray page (), "Are there abnormal findings on the Chest X-ray?"
is Yes. However, ‘specify’ is missing. Please provide the missing response.

Requery:
Requery is sent when a resolution provided by the investigator requires
further clarification or if the resolution provided is not sufficient. For
example: DCF ID 548564

On Concommitant Medication Page (), the response for "Is the subject
currently taking medications?" is missing. Please provide the missing
response. If Yes, please provide the details.
Resolution: Please check as “Yes”.

Here in this case, the resolution has come back incomplete. The resolution
is Yes, however, details are not provided for the question as asked in the
query.
Hence, a requery will be sent asking for the details in reference to the first
query.

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As per DCF ID 548564, the response for "Is the subject currently taking
medications?" is Yes; however, the details are not provided. Please provide
the missing details.

Self Assessment Questions

1. DCF stands for
a. Data Construction Form.
b. Data Creation Form.
c. Data Clarification Form.
d. Data Clearance Form.

2. Data validation is synonymous with

a. Data Cleaning.
b. Discrepancy management.
c. Both a and b.
d. None of these.
3. Discrepancies are primarily for any
a. Incorrect clinical data.
b. Illegible clinical data.
c. Inconsistent clinical data.
d. All of the above.
4. Discrepancy management primarily
a. Consists of electronic and manual checks on the data to assure the
validity and accuracy of the data.
b. Validate data against predetermined specifications.
c. Ensure consistency and data quality.
d. All of the above.

5. Which of the statement is false

a. Electronic and manual discrepancies will be stored within the
confines of a discrepancy management system.

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b. Data processing includes receiving, entering, cleaning and

transferring.
c. Univariate discrepancy appears post data entry.
d. Multivariate discrepancy appears post data entry.

6. DCF is raised to
a. Clinical site.
b. Sponsor.
c. Data Management Centre.
d. Pharmacovigilence.

7. Discrepancy management is primarily performed by

a. Clinical data Coordinator.
b. Data entry associate.
c. Database programmer.
d. Project Manager.
8. Universal rulings
a. Decrease total number of DCFs to the site.
b. Are self evident corrections.
c. Reduce time, labour and cost.
d. All of the above.

9. Discrepancy is a
a. Error.
b. Query.
c. Validation.
d. Resolution.
10. DCF consists of
a. Investigator name.
b. Investigator signature.
c. Resolution.

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d. All of the above.

6.8 Summary
Discrepancy management is an integral part of Data Management. It
includes cleaning and reporting of data recorded at Clinical trials. It
undergoes intensive quality checks, performed as per the Data Validation
Plan to ensure very high and reliable data. Discrepancy Management forms
a foundation for Data Management in every project and are based on SOPs
followed for the data management operations.

6.9 Terminal Questions

1. Define Discrepancy and briefly explain the types of discrepancies?
2. Briefly explain Data Validation Plan.
3. Briefly explain Data Clarification Form.
4. Briefly explain why a requery is sent.
5. Explain how an Edit Check Document is prepared and why?

6.10 Answers to SAQ and TQ

SAQ
1-C 2-C 3-D 4-D 5-C 6-A 7-A 8-D 9-A 10-D

TQ
1. Refer to Section 6.4
2. Refer to Section 6.3
3. Refer to Section 6.7

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4. Refer to Section 6.7

5. Refer to Section 6.7

The boy climbed when the bus stopped.

In the above example, there are two clauses. Only one of them is a
sentence. i.e. which makes a complete sense.

6.11 Abbreviations The boy climbed (Clause I )

Abbreviation Term
CDM Clinical Data Management
when the bus stopped (Clause II)
CRF Case Report Form
DCM Data Collection Module
DE Data Entry
CDMS Clinical Data management System
DEA Data Entry Associate
CDMS Clinical Data Management System
SOPS Standard Operating Procedures
DVP Data Validation Plan
DMP Data Management Plan
CRO Clinical Research Organization

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