data validation

2. What is Data Validation(Edit checks)?
It is a process of cleaning subject data by checking
inconsistencies and discrepancies among responses in
eCRF.
e.g. Verify that AE start date is not greater than AE stop
date

3. The Edit check/Data validation document:
 The specification document is known by various names
i.e. Edit check specification, Data validation specification
document , Data validation plan.
 The DM creates this document referring protocol, CRF
and other trials.
 The document includes the following
a. Edit check name specified by the programmer.
b. The module page , visit for which EC is applicable
c. EC description specifying logic
d. Query text that will appear on the eCRF

4. E.g. of Edit check specification:
Check
Type
Check
Name
Folder Form Question Edit Specification/ Skip
Logic
Query Text
Clinical
Edit
Clin_AE
_ENDAT
_001
Special
Forms
Adverse
Event
What was the
adverse event
end date?
Adverse Event End Date
should be equal or after
the Start date of Adverse
event.
Adverse Event End Date is
before the start date of
adverse event. Please
resolve.
Clinical
Edit
Clin_AE
_ICF_ST
DAT_00
1
Special
Forms
Adverse
Event
What is the
adverse event
start date?
Adverse Event Start Date
should be on or after the
Date of informed consent
Adverse Event Start Date
is prior to Date of
informed consent, please
review if this should be a
Medical History and
resolve.

5. The Edit check/Data validation document:
 These edit checks are then tested by DM against clean
and dirty data in order to perform that they function
correctly or not
 Any comment from the above testing along with edit
check status i.e. PASS/FAIL is documented in the
document
 The above process continues till all the edit checks have
the status of pass by the DM (tester).

6. Type of checks in edit check document
1) Missing Values(e.g. missing dose or DOB)
2) Range checks(e.g.: age should be between 18 to 60)
3) Logical inconsistencies (e.g: no hospitalization is checked
and hospitalization date is provided)
4) Cross module checks (e.g: on AE form action taken was
withdrawn from the study however end of study page
does not suggest reason for withdrawal

7. Creation, Validation, Programming and UAT
DM creates and sends the data validation document for
programmers review
Once the document is finalized the DM creates test cases to be
used while UAT of checks.
The document is then sent to CDP for programming of edit checks
The programmer sends back the DM for UAT of edit checks once all
the edit checks are programmed and tested by programmer on
dummy patients
The programmer on receiving the approval releases the edit checks
in production and schedules batch validation

8. Thank you