EDC & CDMS Systems Flashcards

A CRA is reviewing an EDC system and notices that a subject's weight entry is flagged with a system-generated query. What is the CRA's most appropriate first action?

Answer: Review the source document to verify the correct value, then follow up with the site to resolve the query appropriately

The CRA should verify the data against source documents and work with the site staff to properly resolve the query within the EDC system.

In EDC system user management, why is it important that each user has a unique login?

Answer: To ensure that each action recorded in the audit trail is attributable to a specific individual, maintaining data integrity

Unique user logins ensure that the audit trail accurately attributes every data entry, modification, and review action to a specific named individual, supporting accountability.

What is the purpose of User Acceptance Testing (UAT) before an EDC system goes live at study sites?

Answer: To verify that the EDC build functions as intended per the protocol and annotated CRF before sites begin entering real subject data

UAT confirms that all edit checks, skip patterns, visit structures, and data fields in the EDC are functioning correctly before live study data are entered.

Which term describes the document that maps each data field in the EDC to its corresponding location on the paper CRF or protocol?

Answer: Annotated CRF

The annotated CRF marks each data field with its EDC variable name, form name, and visit, serving as a reference between the paper format and the electronic database structure.

A site's EDC system goes offline unexpectedly during a subject visit. What is the most appropriate contingency measure?

Answer: Use a pre-approved paper backup CRF and enter the data into the EDC once the system is restored

Approved paper backup CRFs ensure continuity of data collection during system outages, and data must be transcribed into the EDC with a note documenting the reason for the delay.

In an EDC system, what is 'double data entry' and when might it be used?

Answer: A validation technique where two operators independently enter the same data, and discrepancies are flagged for resolution

Double data entry is a quality control method where two separate data entry personnel enter the same data independently, with software comparing entries to catch transcription errors.

What does 'role-based access control' mean in an EDC system?

Answer: System permissions are assigned based on a user's job function, limiting what data each user can view, enter, or modify

Role-based access control ensures that each user (site coordinator, monitor, data manager, investigator) only has access to the system functions and data appropriate to their study role.