The document outlines the importance of data validation in clinical data management (CDM), emphasizing its role in ensuring data quality and integrity for statistical analyses. It details the data validation process, which includes edit checks and data clarification queries, all aimed at producing accurate clinical reports. Ultimately, the document asserts that effective data validation is essential for compliance with good clinical practice (GCP) and for delivering high-quality data.

1. Welcome
DATA VALIDATION IN CDM
A.SRAVANI
B.PHARMACY
ID: 160/08/2023
10/18/2022
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2. Index
• Introduction
• Data Validation in CDM
• Data validation process
• Edit checks
• Conclusion
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3. INTRODUCTION
WHAT IS DATA VALIDATION
• Data validation is the process of testing the validity of data in accordance with the protocol
specification.
• Data validation is a series of documented tests of the data with the goal of ensuring the quality
and integrity of the data for statistical analyses and reporting.
• Data validation tests usually check the original, accurate, complete, and consistent aspects of the
data.
• Edit check programs are to identify the discrepancies in the entered data, which are embedded in
the database, to ensure data validity.
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4. Data validation in CDM
• CDM data validation activities are an integral part of GCP and fundamental to the delivery of
high quality data for statistical analysis and reporting.
• Attention should be focused on ensuring that the data are a reasonable representation of
what actually happened at the investigator site.
• The aim is to transform data recorded on CRF’s into information that can be used in the final
clinical report from which the right conclusions about the new drug can be made
• Data clarification queries are issued to the investigator at various stages in the process, in
particular as a result of pre entry review, data entry and running of edit checks.
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5. CDM data validation activities
Investigator site completes CRF
CRFs received by CDM
Pre-entry manual review
Data entry
Edit checks run
Database updated
Final CRF received by CDM
Final data validation checks run
Database updated
Database freeze
Statistical analyses and reporting
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6. EDIT CHECKS
Process for defining and implementing edit checks
• Edit checks consisting of manual and computer checks need to be performed on the data to
ensure the database is accurate and consistent.
• The definition stage consists of producing an Edit Check Specifications (ECS) document and the
implementation stage involves the programming and testing of the checks.
• The first step in the process is for the clinical data manager to prepare and circulate a draft ECS
document to the ECS Team, subsequent to which a document review meeting is held to finalise
the document.
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7. EDIT CHECKS
CDM prepares draft ECS
CDM circulate a draft ECS for review
Team meeting to finalize the ECS
Team review and approve final ECS
CDM issue final ECS
CDM to complete data validation programs
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8. CONCLUSION
• Data validation activities start at investigator site and end with a statement in clinical
reports to indicate that the clinical trial was conducted in accordance with GCP and
that report provides a complete and accurate account of the data collected during the
trial.
• CDM data validation activities are an integral part of GCP and fundamental to the
delivery of high quality data for statistical analysis and reporting.
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9. REFERENCES
• Clinical Data Management, 2nd Edition. Richard K. Rondel, Sheila A.
Varley, Colin F. Webb, ISBNs: 0471-98329-2
• https://www.ofnisystems.com/clinical-data-validation/
• https://www.slideshare.net/DivyaDabbeta/clinical-data-management-
190218435
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10. Thank You!
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