CRA EDC & CDMS Systems 3 — Questions and Answers
Question 1: 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?
- Resolve the query themselves using source documents on file
- Review the source document to verify the correct value, then follow up with the site to resolve the query appropriately (Correct answer)
- Delete the flagged entry and ask the site to re-enter it
- Escalate immediately to the FDA without site involvement
Correct 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.
Question 2: In EDC system user management, why is it important that each user has a unique login?
- To reduce licensing costs by tracking concurrent users
- To ensure that each action recorded in the audit trail is attributable to a specific individual, maintaining data integrity (Correct answer)
- To allow the sponsor to restrict which fields each user can see
- To comply with HIPAA's minimum necessary standard for data sharing
Correct 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.
Question 3: What is the purpose of User Acceptance Testing (UAT) before an EDC system goes live at study sites?
- To train all site staff on how to use the system
- To verify that the EDC build functions as intended per the protocol and annotated CRF before sites begin entering real subject data (Correct answer)
- To obtain FDA approval for the EDC software
- To test whether the server can handle peak traffic loads
Correct 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.
Question 4: Which term describes the document that maps each data field in the EDC to its corresponding location on the paper CRF or protocol?
- Data Management Plan
- Annotated CRF (Correct answer)
- Edit Check Specification
- Data Transfer Agreement
Correct 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.
Question 5: A site's EDC system goes offline unexpectedly during a subject visit. What is the most appropriate contingency measure?
- Cancel the visit and reschedule the subject
- Use a pre-approved paper backup CRF and enter the data into the EDC once the system is restored (Correct answer)
- Enter data from memory after the system is back online
- Contact the FDA immediately to report the outage
Correct 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.
Question 6: In an EDC system, what is 'double data entry' and when might it be used?
- Entering data into both the EDC and a parallel paper CRF simultaneously at all times
- A validation technique where two operators independently enter the same data, and discrepancies are flagged for resolution (Correct answer)
- Requiring two different site staff to approve each data field before it is saved
- Submitting data to both the sponsor and the CRO at the same time
Correct 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.
Question 7: What does 'role-based access control' mean in an EDC system?
- Users can access the EDC from any device based on their geographic location
- System permissions are assigned based on a user's job function, limiting what data each user can view, enter, or modify (Correct answer)
- Site staff can grant each other temporary elevated access during busy visits
- Access is controlled by the study's IRB based on protocol role assignments
Correct 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.
CRA EDC & CDMS Systems 3
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?