CCDM Database Lock & Study Close-Out

Question 1

Which activity must be completed before a clinical database can be locked?

Accepted Answer

All data queries resolved and final data review and reconciliation completed

Answer

Lock is only appropriate once data cleaning is complete. That means open queries are resolved, external and SAE data are reconciled, coding is finalized and QC checks are done. The other options happen after lock or are not part of the process.

Question 2

What is the main purpose of a database lock?

Accepted Answer

To prevent further changes so the dataset is final for analysis

Answer

Locking removes edit access so the analysis dataset is stable, reproducible and defensible. The audit trail is kept, not removed.

Question 3

In a blinded trial, when is the treatment allocation (blind) normally broken for analysis?

Accepted Answer

After database lock and sign-off, per the statistical analysis plan

Answer

Unblinding follows database lock and formal authorization. This protects the integrity of the study and prevents data changes from being influenced by knowledge of treatment.

Question 4

After a database is locked, an error is found in a data point. What is the correct approach?

Accepted Answer

Follow a documented unlock/re-lock procedure with justification and approvals

Answer

Post-lock changes need a controlled, documented unlock process. It requires a justification, approval from the stakeholders and a full audit trail, and the database is then re-locked.

Question 5

Which item is typically archived at study close-out for the data management function?

Accepted Answer

The final locked database, data management plan, CRF annotations, audit trail and validation documentation

Answer

Archiving must preserve the data and the records showing how it was collected, cleaned and validated. That lets the study be reconstructed during an inspection or audit.

(CCDM) Certified Clinical Data Manager Practice Test

(CCDM) Certified Clinical Data Manager Practice Test

CCDM Database Lock & Study Close-Out