This document provides an overview of data loading and data entry for clinical trials. It discusses the types of data that data entry operators should be aware of, including medical terms and abbreviations. It describes the process of double data entry, where two operators independently enter the same data from case report forms to ensure accuracy. Common errors made during data entry are also outlined, such as spelling errors, numerical errors, and missed terms. The document provides remedial actions like developing a mock database for practice before production entry. It emphasizes the importance of leaving proper spacing between words and being careful to not change responses when tabbing between fields.

1. Data Loading and Data Entry
Presenter :Priya Gehlawat

2. Icons Used
Questions
Demonstration
Hands on
Exercise
Coding
Standards
AWelcome
Break
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ReferenceTestYour
Understanding
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3. Overview
3

4. Objectives
4

5. Do You Know
5

7. 7
Dates and Events
DATA
Medical
Terminologies
Numerical Data
Medical & General
abbreviations
DEO (Data Entry Operator) should be aware of:
- The kind of data to be entered
- Project specific guidelines & standard guidelines
- Good knowledge of the medical terms

8. Double Data Entry
CRFs received at Data
Management centre
First DEO performs tracking and
first pass data entry
Pages released from 1st pass and
ready for 2nd pass entry
Second pass entry performed by
2nd DEO
Operator
comments/ Manual
query raised
System generated
discrepancies
Mismatch entries
Second pass entry complete
NO
YES Comparison
Reconciliation

9. • Enter data from the CRF.
• Check if there are any
illegible text or problems in
the data. If so, create an
Operator Comment.
• Or check if there are any
investigator comments.
• If the investigator comment
exists enter data in the
investigator comment section.
• Else check for any System
generated errors.
• If discrepancies are found,
save the data with
discrepancy or re-enter the
correct value.
• Else exit entry.

13. Spelling
Errors
Numerical
Errors
Spacing
Errors
Response
Errors
Date
Errors
Missed
General
Terms
Illegible
Data
DEI Not
Followed

14. s

21.  Trend Observed:
 Opening the CRF and database in one window
 Toggling between windows (CRF, Database, DEI)
 Cause:
 Database development more tilted towards copying the CRF layout with
little importance given to the ease of entry during actual production
 Remedial Action:
 Database should be tested for ease of entry
before actual production

22.  Trends Observed:
 After completing process trainings, data entry associates either enter the
production directly or are shadowed for some time in actual production
 Lack of typing skill – looking at the keyboard while typing
 Cause:
 Absence of mock database
 Mock database not used even if present
 RemedialActions:
 Mock database should be developed for practice before entering
data in production database
 DE associates should practice onTypingTutor

23.  Data in the CRF – Infection 2-3 times
 Data entered by DEO1 – Infection 2-3 times
 Data entered by DEO2 – Infection2-3 times
 Preventive Action :
 Please ensure that appropriate spaces are left in between the words.

24.  Data in the CRF – Response ticked in the CRF -Yes/Y
 Data entered by DEO1(First Pass) – Yes/Y
 Data entered by DEO2 (Second Pass) – No/N
 Preventive Action :
 Please be alert while doing DE, refrain from using ‘Tab’

25.  Data in the CRF – Only 20ml of blood was drawn
 Data entered by DEO1 – Only 20ml of blood was drawn
 Data entered by DEO2 – Only 20ml blood was drawn
 Preventive Action :
 Please ensure adequate DE of each word as mentioned in the CRF

26. When data in the CRF is illegible, the DEOs will try their best to
decipher what has been written (and also issue a sponsor note for the
illegible data).
When captured as an error in the verification report, the TL – DE will
use his best discretion for analyzing the same and make appropriate
entry in the database.

27. • Do’s • Don’ts

33. Questions
33

34. Summary
34

35. Lend a Hand
35

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Data Entry and Data Loading