Data Entry Methods

Dr. Jill Shukla

 Understanding Data
Entry
• Understanding data entry: process of
entering data from CRF to response
fields in any CDMS following few
guidelines

CRF
 Understanding
Data Entry
• To understand data entry better, one has to
follow certain terms like work item, work flow
Work Item Work Flow

Integration Of
Various
“Technical
Components” To
Collection Of Route Workitems

“CRF Images”
 Before Starting with Data Entry
Process
We are all Trained…and we have
our Elec. Signatures ….

• Understanding 21 CFR Part 11, that is,

Code of Federal Regulations part 11
chapter 21
• FDA defines that persons handling clinical
data have to be sufficiently trained &
need to have electronic signatures of
their own
• Therefore, each person will have
electronic signature as part of 21 CFR
Part 11 compliance
 Entering Data
• Accuracy of transcribing data
• Dealing with problem data
• Making edits & changing data
• Quality control
 Audit Trail & 21 CFR Part
11
Audit Trail means ...
• “record of activites”
• Data entered, deleted,
altered, updated etc.
• E-signature help us

identify
• Who did what ?
 Data Entry Screen
LEFT SIDE
• UNDERSTANDING
CDMS
DATA ENTRY
SCREEN

CDMS CRF

RIGHT SIDE
SCANNED CRF IMAGE
Types of Data Entry

• Interactive Verification
• Blind Verification
• Batch Verification
• Compare
• Single Data Entry
 Double Data Entry
• DEO selects
workitems
(consisting of CRF Work Item
pages)

• After selecting work Release

item, completes data
entry of all CRFs & Work Item
releases work item
for next step
Data
Entry
 • This refers to data
being entered to
database for first
time
• DEO enters all
data of each
document &
releases work
item
• Then second pass
First Pass entry will be
Data Entry performed
• Second pass entry
done by a “DEO”
• This becomes first
quality check in CDM
process
• Both DEO & system
contribute to this first
quality check in CDM
process
• System gives an
alert if second pass
enters anything
different from first
pass Second Pass
• Later correct value
is confirmed & Data Entry
entered
 Dealing with Different
Kinds of Data
• DEO (Data Entry Operator) should be
aware of kind of data to be entered
• Also, awareness of project specific
guidelines & standard guidelines is a
must
DATA ABBREVIATIONS
• Data types
GENERAL & MEDICAL
DATES/EVENTS
MEDICAL NUMERICAL
TERMINOLOGIES DATA
 DD-MM-YYYY
Handling
Dates ??
• Recording dates on case report forms -
plays very integral point
• DEOs must know different schemes of
recording dates
• Indians follow dd-mm-yyyy pattern
• Americans follow mm-dd-yyyy pattern
• Few European countries follow yy-
mm-dd pattern
 Medical Terminologies
• DEOs should encourage
themselves from
beginning to verify (use
Refer Check My
online sources) & be Spellings
Online
aware of spellings of Twice !!
Sources
various medical
terminologies
• This is essential because
a slight change or mis-
spelt term can mean
totally different
• Also, many medical
terminologies have
more than one way of
spelling
 Stop Entering If Not
Sure

• During entering data, S T O P !!!

DEOs have liberty of
entering comments -
Insert
called “Operator Yes…..
Comments” for a Comment
Point
particular data point If Not
Noted
• Operator comments are Sure…ok
entered when DEOs are
not sure about any Operator
illegible text/unclear Comment
text
• Also, if data is recorded
in an erroneous way
operator comments can
Data Collection Instrument
• DCI is an equivalent of a CRF (Case Report
Form)
DCI CRF

• DCI can have several groups of DCM - Data Collection

Modules DCM 1
DCM 2

DCM 3
 Data Collection
Module- DCM
• DCM is a
collection of
– similar questions
– group of related

?? ?
questions
• E.g., in a subject
demography form
– Date of birth
– Sex
– Race
– Height/weight
 Data Seen in Header Section
Subj. Subj. Visit
• Header Initial No. No.
information
includes
 Subject number
 Initials of subjects
 Visit number
• Confidentiality of Header
subjects in
clinical trial
• Subject number
• Each of subjects in Header
clinical trial will be Information
assigned a particular
subject number
• This facilitates
accessing
information of
particular subject Subj.
during verification of Number
data
 Initials of Subject
• Further to subject number
• Subject ‘s name is usually reduced to a
combination of “three-letter”
Confidential
eg., Information
– Name- naveen prasad sharma
– Initial recorded as - “n p s”
• Confidentiality of subject throughout
clinical trial should be secured & not
disclosed; hence only initials are recorded
 DVG or Discrete Value
Groups
• It is a kind of question where in there is a fixed
set of answers
• DEOs have to just select one of response as
answer to a question instead of keying in text
• eg., subject diagnosis

Data Entry Person

Will
Just Select One Answer
From Drop Down
•Mild Asthma Menu
•Moderate Asthma
•Severe Asthma
 Heads-up Data Entry

I Review
Data As I Enter
Data
•Also called thinking data
entry persons
•They raise a flag when
data is illegible for data
reviewers or data
managers
Heads Down Data Entry
• Simply put, these entry
personnel enter what
they see on CRF
• Heads down data entry
are faster as they follow
natural flow of CRF
• Second pass entry is
provided after heads
down data entry
• Only few checks
provided while entry is
made
 DE Guidelines

Best Practices of Data

Entry

•DEOs should develop

habit of referring data
entry guidelines when in
When In
doubt
Doubt
•If still unclear they can
Always
raise a comment or flag
Refer
for further review of
Guidelines
data
 Standard & Project Specific
Guidelines Which One To
Follow ?
Which DEOs are required to
Guidelines To
Follow..?? follow numerous
guidelines

They should be aware

that always
“project specific
guidelines supercedes
standard guidelines
”
 Single Entry
• Very rare
• Extensive checking routines should
be built into data entry application
• DEO to be trained in protocol &
review entry process
• Possibility of higher error rate,
hence more extensive audit needed
 Quality Assurance (QA) &
Quality Control (QC)
• QA is a process, QC is a check of
process
• Accuracy of data entry checked by
auditing data stored in database
against CRF
• Error Rate: “number of errors
against number of fields on
CRF/Database”
• Acceptable error rates
• Ongoing audits
 Error Rates
Can be minimized by
• Thorough training of DE personnel
• High level of QC
• Good DEM
• Good data entry guidelines
• Use of the ‘dyna_doc’
 Other activities handled
by DE
• Scanning
• Indexing
• QA
• QC of listings
• Tracking
• Maintenance of Data Master Files
Thanks!