SCDM Data Reconciliation and Validation 1

Question 1

What is the primary purpose of data reconciliation in clinical data management?

Accepted Answer

To ensure consistency and completeness of data across multiple sources

Answer

Data reconciliation ensures that data from different sources (e.g., EDC, lab systems, IRT) are consistent, complete, and in agreement before database lock.

Question 2

During external data reconciliation, a discrepancy is found between the EDC system and the central lab data. What is the appropriate first step?

Accepted Answer

Investigate the source of the discrepancy using original source documents

Answer

Investigating the discrepancy against source documents is the correct first step to determine which record is accurate before making any changes.

Question 3

Which type of validation check verifies that a date entered in a CRF falls within the acceptable range of the study period?

Accepted Answer

Range check

Answer

Range checks verify that a data value falls within predefined acceptable minimum and maximum boundaries, such as valid dates within a study timeline.

Question 4

What does a 'discrepancy management' process in clinical data management primarily involve?

Accepted Answer

Identifying, documenting, resolving, and closing data queries

Answer

Discrepancy management is the systematic process of identifying data issues via queries, tracking them, obtaining site responses, and closing them once resolved.

Question 5

In clinical data management, a 'hard edit' (or hard stop) in an EDC system means:

Accepted Answer

The system prevents data entry from being saved until the error is corrected

Answer

Hard edits prevent the user from saving or progressing past a data entry point until the entered value meets the validation criteria.

SCDM - Society for Clinical Data Management Practice Test

SCDM - Society for Clinical Data Management Practice Test

SCDM Data Reconciliation and Validation 1