CRA EDC & CDMS Systems 2 — Questions and Answers
Question 1: In an EDC system, what is the primary purpose of a 'skip pattern' (conditional branching)?
- To skip pages that have already been reviewed by the monitor
- To automatically navigate users past questions that are not applicable based on prior responses (Correct answer)
- To remove fields from the audit trail when they are irrelevant
- To mark sections as optional so sites can complete them later
Correct answer: To automatically navigate users past questions that are not applicable based on prior responses
Skip patterns use conditional logic to hide or bypass fields/pages that are not relevant given earlier data entries, reducing site burden and data entry errors.
Question 2: Which regulatory document specifically addresses the use of electronic records and electronic signatures in clinical trials conducted in the US?
- ICH E6(R2) GCP Guideline
- FDA 21 CFR Part 11 (Correct answer)
- EU Annex 11
- ICH E9 Statistical Principles
Correct answer: FDA 21 CFR Part 11
FDA 21 CFR Part 11 establishes the criteria under which electronic records and electronic signatures are considered trustworthy and equivalent to paper records.
Question 3: A site coordinator accidentally enters a wrong date for a subject's visit. After correcting it in the EDC, what must be preserved?
- Only the corrected value should remain to avoid confusion
- Both the original entry and the correction, with reason and timestamp, in the audit trail (Correct answer)
- The original value must be physically crossed out in the eCRF
- A separate paper log must document the change
Correct answer: Both the original entry and the correction, with reason and timestamp, in the audit trail
EDC audit trails must capture the original value, the corrected value, the date/time of change, and the user who made the change, ensuring data integrity.
Question 4: What does 'edit check' mean in the context of an EDC system?
- A process where the sponsor reviews all data before database lock
- An automated validation rule that flags inconsistent or out-of-range data entries in real time (Correct answer)
- A manual review performed by a data manager at the end of the study
- A report generated to verify randomization codes
Correct answer: An automated validation rule that flags inconsistent or out-of-range data entries in real time
Edit checks are programmed rules within the EDC that trigger immediate alerts when entered data violates predefined logical or range constraints.
Question 5: In CDMS terminology, what is a 'discrepancy' (also called a query)?
- A formal protocol deviation submitted to the IRB
- A flag raised when data does not meet validation rules or appears inconsistent, requiring site clarification (Correct answer)
- A request by a site to add a new data field to the CRF
- A notification to the sponsor that a subject has withdrawn
Correct answer: A flag raised when data does not meet validation rules or appears inconsistent, requiring site clarification
A discrepancy or query is a question raised to the site when data entries are missing, inconsistent, or out of range, prompting the site to clarify or correct.
Question 6: Which of the following best describes 'database lock' in a clinical trial?
- Encrypting the database to prevent unauthorized access during the trial
- The formal process of freezing the clinical database after all data have been cleaned and verified, preventing further edits (Correct answer)
- Locking individual patient records after the subject completes the study
- Archiving EDC data to a separate server at study completion
Correct answer: The formal process of freezing the clinical database after all data have been cleaned and verified, preventing further edits
Database lock is a controlled milestone at which all data cleaning is complete, the database is declared final, and no further changes are permitted prior to analysis.
Question 7: What is the main advantage of real-time data entry in an EDC system compared to paper-based CRFs?
- It eliminates the need for source document verification
- It allows sponsors and monitors to review and query data almost immediately after entry, accelerating data cleaning (Correct answer)
- It removes the requirement for an audit trail
- It allows subjects to enter their own data without site oversight
Correct answer: It allows sponsors and monitors to review and query data almost immediately after entry, accelerating data cleaning
Real-time EDC entry enables near-immediate visibility of data to monitors and data managers, allowing queries to be raised and resolved faster than with paper CRF transcription.
CRA EDC & CDMS Systems 2
In an EDC system, what is the primary purpose of a 'skip pattern' (conditional branching)?