Query Management

Understanding Discrepancies
• Discrepancies are “Inconsistencies”
found in the clinical trial data which nee
d to be corrected as per the study proto
col (the guiding document)
• For better query management, one has
to know the source or origin of discrepa
ncies
• Data in clinical trial should be congruent
with the study protocol
 Data Inconsistencies

Data complete?

Data Data
Data legible?
Inconsistencies consistent?

Data correct?
Data logical?
 Discrepancy Types

Completeness & Real-world

Consistency: checks:
 Checks for empty  Range checks
fields  Discrete value
checks
 Looking for all
 One value
related items
greater/less
 Cross-checking than/equal to
values another
 Discrepancy Types

Quality control: Compliance &

 Are dates in logical Safety:
sequence?  Are visits in
 Is header compliance with
protocol?
information
 Inclusion/exclusion
consistent? criteria met?
 Any missing visits or  Checking lab values
pages? against normals
 Comparison of
values over time
 Sources of Discrepancies
• Manual review of data and CRFs by
clinical team or data management

• Computerized checks of data by the

clinical data management system:
Validation/discrepancy designing and
build-up into the database
Common Features Included in
Discrepancy Systems
• Source of the discrepancy
• Date & time it was identified
• Linked or duplicate discrepancies
• Status of discrepancy in the system
• Data and time query sent to investigator
• Query form identifier
• Final resolution
• Date & time of resolution
• Source of the resolution
 Registering Discrepancies
Discrepancy management systems are
designed to:
 Supplement the data management
system audit trail
 Provide summary information on the
causes of discrepancies
 Provide metrics on the time to resolve
issues
 Help eliminate over-reporting and
reporting of duplicates
 Main Tool for Query
Management
• Clinical Data Management staff send
out “Data Clarification Forms” or DCFs i
n the process of query management
• Other names given to this form:
 Query forms
 Correction forms
 Discrepancy forms
Process of Query Management
• Create
• Send
• Track
• Resolve
• Re-query
 Creating Queries
• Discrepancies entered onto query form by
hand based on reports from the
discrepancy management system, or
system may create them automatically
• In the case of remote data entry systems,
queries are entered directly into database
• Discrepancies covered on a single form
will all belong to one site but may refer to:
d) One or more patient for that investigator
e) A single patient but multiple CRF pages
f) A single patient and a single CRF page only
 Sending Queries
• Query form delivered to site via fax,
paper mail, the CRA in person, or e-
mail
• In the case of remote data entry
systems, the queries are immediately
accessible to the investigator, who can
view the query online
 Tracking Queries
• Data management tracks flow of queries to
and fro between self and investigator
• Data management ensures that query
responses are received and integrated
within the specified timeliness
• Tracking spreadsheets to be maintained
Tracking Queries

I have lost
the track !!! Which queries went and
when?
What discrepancies were
sent?
Have the queries been
returned and processed?
 Resolving Queries
• Data management integrates the
query response into the database
• Common types of resolutions:
c) The value in question maybe correct as is
d) An actual measurement may replace a
missing value
e) A corrected value may replace an incorrect
value
f) The value maybe wrong but no corrected
value is available
 Re-queries
• Needed when the investigator
provides
b) No response
c) Incorrect response
d) Inconsistent response
e) Incomplete response (including signature)
f) Same response
 Re-queries
• Possible approaches to handle
incomplete resolutions:

c) Re-issue the discrepancy on a new query

form if corrections take place on the form
d) Leave that one discrepancy as unresolved
and await a re-send of the query form
e) Leave it as unresolved and await correct
CRF
Data Management
issues DCF

Fax/email

Site Investigator cross-

checks with “source
document”and
answers the query
forms
Requery
Fax/email

Data Management
updates database
 Discrepancy Statuses
• Identified or registered
• Reviewed and still open
• Sent to investigator
• Duplicate or linked
• Data updated
 Resolution Types
• Resolved (with data update)
• As is (i.e., not a problem)
• Cant be resolved (but wrong)
• Data management edit
 Resolution Sources
• CRA
• Data management
• Site, by phone
• Site, by query form
General Tips for Query Wording

• Good understanding of guidelines

• Knowledge about Protocol
• State a problem in a simple way
• Be Precise or to the point while wording
the query text
• Use proper punctuation and
grammatically correct sentences
• Avoid repetition of words in query text
 Formula for Query Writing
• The formula of “L S A”
• Locate the discrepancy
• State the discrepancy
• Ask for resolution
• A simple way of going about any query
text is to first mention the location of the
query, then state the discrepancy/issue,
and later ask for the resolution
• Note: A query text should never be
leading to the Investigator
 Illogical Data
• Date of birth given as 30 Feb 1977
• This is an example of illogical data
• Since it is very clear that the February month
has no 30 th day, this data has to be cross ve
rified with the Investigator

February 30 th…!!!
 Query for illogical data:
30 Feb 1977
Query text:
• “On page 2, Demography record, the Date of
birth is recorded as 30 Feb 1977. Please veri
fy the date of birth.”
As per the formula for query writing,
• “On page 2, Demography record” (location of
the discrepancy)
• “the Date of birth is recorded as 30 Feb 1977”
(discrepancy stated)
• “Please provide the correct date” (Resolution
requested)
 Inconsistent Data
• Situation: The Start Date of Paracetamol at visit 2 is given
as 23-Feb-1984 and is continuing. At the next visit i.e., at
visit 3, the Start Date is given as 25-Feb-1984.
• Understanding the problem: Paracetamol at visit 2 was
given and was not stopped at visit 2. Hence, it should have
the same Start Date at next visit as well.
• Ambiguity: It is also possible that the subject might have
stopped taking Paracetamol at visit 2 and taken a different c
ourse of Paracetamol at next visit- visit 3 and hence a differ
ent Start Date 25-Feb-1984 was recorded.

Was the medication continuing

from visit 2…?
 Paracetamol with different
Start Dates at subsequent visits
Query text:
• “On page 20 visit 2, medication Paracetamol
(Start Date 23-Feb-1984) and continuing is re
corded. However, in the subsequent visit 3,
medication is recorded with a different Start D
ate 25-Feb-1984.
Please verify the correct Start Dates for the
medication at both the visits, else provide a st
op date for the medication at visit 2.”
 Incomplete/Missing Data
• On Demography page, sex and ethnicity of
the subject is not mentioned

Query text:
• “On page 2, Demography record, sex and
ethnicity of the subject is not recorded.
Please provide the required dat
a.”

Data
missing…
 Data without Units
• Weight of the subject is recorded without
units
Query text:
• “On page 5, weight of the subject is recorded
as 150, however the unit of weight is not reco
rded. Please provide weight recorded with th
e applicable units.”

Kilograms or pounds ???

 QA/QC
• All changes to database via query
forms to be documented and captured
in audit trail
• Differences between database and CRF
to be supported by query response
• Accurate query integration key
component of audit findings
• Consistent inaccuracies in query
response communicated to investigator
in the form of feedback