Why the discrepancy management is needed? ..is to have accurate results.

Clinical trials are conducted to collect and analyze data regarding the safety and efficacy of new
drugs and devices.

That said, accurate results for any clinical trial are determined by the quality of the collected data.
However, data collected from the investigator sites are never completely consistent, requiring
sponsor companies to validate the data in order to get a true representation of what took place in
the trials. In general, the data management group or the data manager is responsible for checking
the data for discrepancies and getting the data cleaned up.

DISCREPANCY MANAGEMENT:

Discrepancy management is a process of cleaning subject data in the clinical data management it
includes manual checks and programmed checks. CDM team revaluates every discrepancy in
database at the regular intervals to ascertain that they have been resolved.

Cleaning data is one of the principle roles in the of data management. As data comes in from sites, it
is entered into the clinical database where it is subjected to the edit check process to discover errors
or data discrepancies.

(These Errors are resolved by quering)

QUERY

When an item or variable has an error or a query raised against it, it is said to have a
“discrepancy” or “query”.

A query is an error generated when a validation check detects a problem with the
data. Validation checks are run automatically whenever a page is saved “submitted”
and can identify problems with a single variable, between two or more variables on
the same eCRF page, or between variables on different pages. A variable can have
multiple validation checks associated with it.

Discrepancy managementThis is also called query resolution. Discrepancy management includes

reviewing discrepancies, investigating the reason, and resolving them with documentary proof or
declaring them as irresolvable. Discrepancy management helps in cleaning the data and gathers
enough evidence for the deviations observed in data. Almost all CDMS have a discrepancy database
where all discrepancies will be recorded and stored with audit trail.
Where data entered does not pass validation rules then a data query may be issued to the
investigative site where the clinical trial is conducted to request clarification of the entry. Data
queries must not be leading (i.e. they must not suggest the correction that should be made). For
electronic CRFs only the site staff with appropriate access may modify data entries.

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Mistakes happen in the course of data entry. A research coordinator,

intending to input a weight of 80 kilograms, leaves the field before striking
the “0” key. Her colleague, completing a field for temperature, enters a
value of 98, forgetting that the system expects the measurement in Celcius.
But no adult enrolled in a clinical study weighs 8 pounds. And the patient
with a body temp of 98 degrees Celsius? “Fever” is something of an
understatement.
Left standing, errors like the ones above distort analysis. That’s why data
managers spend so much time reviewing submitted data for reasonableness
and consistency. What if it were possible to guard against introducing error
in the first place? With electronic forms, it is possible.

“Edit checks,” sometimes called “constraints” or “validation,” automatically

compare inputted values with criteria set by the form builder. The criteria
may be a set of numerical limits, logical conditions, or a combination of the
two. If the inputted value violates any part of the criteria, a warning
appears, stating why the input has failed and guiding the user toward a
resolution (without leading her toward any particular replacement).
Edit checks may be simple or complex; evaluate a single item or a group of
related items; prevent the user from moving on or simply raise a flag. You
can learn all about these differences below. The goals of edit checks are
universal: higher data quality right from the start!

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EDC

A EDC systems have discrepancy management systems called as Edit check/validation check that is
programmed using any known programming language

Programmed edit checks execute to find errors or discrepancies in the relationships between data
variables or elements.
Electronic Data Capture (EDC) is software specially designed for the collection of clinical data in
electronic format, often for use in human clinical trials. EDCs, like Teamscope, have built-in query
management and comply with Good Clinical Practice (GCP). EDC eliminates the need for paper
forms and drastically simplifies data monitoring.

EDC AND QUERY MANAGEMENT EDC systems by design include a tool that provides a simple way for
generating and resolving study queries. The entire query management process is handled within the
EDC system. With this system, users can easily create a query for a patient and send it to the
investigator via the EDC interface. The EDC system will then track the query and record any change
How queries work
SAS dataset back-end and a user interface developed using SAS/IntrNet®. With OQMS, data
managers connect to the system with their username and password, and manage and track the
discrepancies of a study through a user-friendly interface. The application allows multiple users to
connect simultaneously and securely while working on the study queries. Since the back-end and
user interface are both developed in SAS, additional SAS-based modules may be added to the
system. For instance, users can view patient profiles by clicking on the patient number, access the
audit trails to see the history of each discrepancy, as well as export the data in Excel format.
Furthermore, many trial-specific reports can be easily programmed and added to the interface
query management is built on top of our data validation system.

Your first step is to add a Condition to any data field: Data queries are automatically
generated when a value is invalid, matches warning criteria or
is required and has been left empty:

you can see:

 Who in your team created this data query

 When it was originated
 The data that caused
 The condition that triggered it: Invalid, Warn or Required
 The status: Open or Resolved
By clicking on the status of a query you may change from Open to Resolved, and vice versa.
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Alternatively, whenever the data issue is fixed, the platform automatically

✨changes the status of the query from Open to Resolved:

Classification of Discrepancies:
-Auto query

-Manual query

an “auto-query,” arises from programming. The system itself flags the invalid data and adds it
to the log of queries that must be resolved before the database can be considered locked

“manual query,” starts when a human, possessing contextual knowledge the system lacks,
indicates her skepticism concerning a value.
To resolve or “close” an auto-query, the user who first entered the invalid data (or another
study team member at the clinical site) must either:
 submit an updated value that meets the edit check criteria
 communicate to the data manager that the flagged data is indeed accurate, and
should stand
The data manager may close a query on data that violates an edit check. In these cases, she is
overriding the demands of the validation logic, but only after careful consideration and
consultation with the site.

To resolve a manual query, the site user and data manager engage in a virtual back and forth–
sometimes short, sometimes long–to corrobate the original value or arrive at a correction.

Manual discrepancy – Diabetes is recorded in Medical History however medication name for
diabetes have not been recorded on the Conmed (Concomitant Medication) module

Data managers may manually review CRF data looking for odd patterns or inconsistencies that
have not been programmed into the edit checks. • These discrepancies may relate to one or
more data-points/questions • Based on manual review of data ,Queries or DCFs are raised in the
clinical database or sent to the site and tracked for resolution.

Manual Checks • AE 1 (Vomiting) with start date (5-Jan-09) & stop date(6-Jan-09) seems to be
duplicate of AE 3 (Vomiting ) with start date (5-Jan-09) & stop date(6-Jan-09). Kindly verify and
amend the CRF as applicable

Discrepancies identified by System –  Discrepancies identified by the system with the help of
Edit checks  These are programmed  Example – Pregnancy have been marked “YES”
however the SEX is recorded as “MALE” DISCREPANCY CLASSIFICATION BASED ON ITS
ORIGIN

14. System generated discrepancies are those that are generated when a response entered in
the database does not meet the attributes/ Validation Procedures specified for a given field
during study build – • These are discrepancies that relate to – – single data point – Univariate
discrepancy. – multiple data-point – Multivariate discrepancy. They are automatically created
during Data Entry • They are caused due to the following errors on the CRF: —Missing
DataValues —Incomplete Data —Out of Range Data —Wrong Data-type

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Discrepancies can be resolved in various ways:

- Update data that led to the discrepancy with correct data

 - Accept the data as correct, and resolved  For Example: Heart Rate is given ND (Not
Done) flags Discrepancy, can be resolved as No Action Required if it is same in CRF 
Accept the data as incorrect, but resolved  For Example: Date of Collection of sample is
different from the visit date, but investigator confirms the same WAYS OF RESOLVING
DISCREPANCIES

43. There are instances where unresolved discrepancies are accepted as it is. These are
appropriately documented and provided to the study team and statistician for analysis purposes.
Examples: Weight not taken at V2, ‘Not Done’ can be entered by the Data Managers in at this
visit as agreed by study team. Per protocol Lab sample is expected to be collected at V1,
however if site confirms that the Lab sample was not collected at this visit then this is acceptable
as is as agreed by study team. UNRESOLVED ACCEPTABLE QUERIES 43
44.  When any good discrepancy management system is teamed with an effort to identify
discrepancies starting early in the data handling for a study and continuing throughout, it is
possible to cut down the time to close of study to within a few days of receipt of the last CRF.

Resolving a query isn’t just a matter of removing the red flag. If the data
manager accepts the out of range value, she must indicate why. If the
research coordinator inputs a corrected value, she too must supply a reason
for the change as part of the query back and forth. The goal is to arrive at
the truth, not “whatever fits.”

“Edit checks,” sometimes called “constraints” or “validation,” automatically

compare inputted values with criteria set by the form builder. The criteria
may be a set of numerical limits, logical conditions, or a combination of the
two. If the inputted value violates any part of the criteria, a warning
appears, stating why the input has failed and guiding the user toward a
resolution (without leading her toward any particular replacement).