SCDM Data Reconciliation and Validation 3

Question 1

Which document formally defines the edit checks and validation rules to be programmed into an EDC system?

Accepted Answer

Data Validation Plan (DVP) or Edit Check Specification

Answer

The Data Validation Plan (DVP) or Edit Check Specification document details all programmatic checks, logic, and rules that must be implemented and tested in the EDC system.

Question 2

What is the purpose of User Acceptance Testing (UAT) in the context of EDC validation?

Accepted Answer

To confirm that the EDC system functions as specified before going live with data collection

Answer

UAT is performed by end users (data managers, clinical operations) to verify that the EDC system meets functional requirements before it is deployed for actual data collection.

Question 3

A completeness check in data validation is designed to:

Accepted Answer

Confirm that all required fields have been filled in

Answer

Completeness checks identify missing data by verifying that all required or conditionally required fields have been populated.

Question 4

During IRT (Interactive Response Technology) reconciliation, which data element is most critical to verify?

Accepted Answer

Subject randomization numbers, treatment assignments, and kit dispensation records

Answer

IRT reconciliation focuses on confirming that subject randomization, treatment assignments, and kit/drug dispensation records in the EDC match the IRT system records.

Question 5

What is the significance of maintaining an audit trail throughout the data validation process?

Accepted Answer

It provides a chronological record of all data changes, supporting data integrity and regulatory compliance

Answer

Audit trails provide a tamper-evident record of who made what change, when, and why, which is required by regulations (e.g., FDA 21 CFR Part 11) to ensure data traceability and integrity.

SCDM - Society for Clinical Data Management Practice Test

SCDM - Society for Clinical Data Management Practice Test

SCDM Data Reconciliation and Validation 3