SCDM Data Reconciliation and Validation 2

Question 1

What is the purpose of a 'soft edit' (or soft stop) in an EDC system?

Accepted Answer

To allow data entry to continue after the user acknowledges a potential issue

Answer

Soft edits generate a warning to alert the data entry user of a potential issue but allow them to proceed and save the data after providing a justification or acknowledgment.

Question 2

Patient profile reviews during data validation are primarily conducted to:

Accepted Answer

Identify data anomalies or patterns at the subject level that edit checks may miss

Answer

Patient profile reviews allow data managers to assess data coherence and plausibility at the individual subject level, catching issues not flagged by automated edit checks.

Question 3

Which activity is performed as part of 'external data reconciliation' in a clinical trial?

Accepted Answer

Matching data in the clinical database against data from third-party vendors such as labs or IRT

Answer

External data reconciliation involves comparing and aligning clinical trial data from the primary EDC/database with data received from external sources such as central labs, IRT systems, or PK labs.

Question 4

A cross-form validation check would flag an error if:

Accepted Answer

A subject's adverse event start date precedes the date of informed consent

Answer

Cross-form validation checks relationships between fields across different CRF forms—in this case, verifying that an adverse event cannot start before the subject consented to the trial.

Question 5

What is 'database lock' in clinical data management?

Accepted Answer

The formal process of restricting further edits to the clinical database after data cleaning is complete

Answer

Database lock is a formal, documented step marking the end of data cleaning where the database is set to read-only, preventing further modifications before statistical analysis.

SCDM - Society for Clinical Data Management Practice Test

SCDM - Society for Clinical Data Management Practice Test

SCDM Data Reconciliation and Validation 2