CCDM Electronic Data Capture 3 — Questions and Answers
Question 1: What is the primary purpose of a User Acceptance Testing (UAT) phase before an EDC system goes live?
- To train site staff on GCP regulations
- To verify that the configured system meets all protocol requirements before use in the actual trial (Correct answer)
- To validate the statistical software used for analysis
- To obtain IRB approval for data collection
Correct answer: To verify that the configured system meets all protocol requirements before use in the actual trial
UAT confirms that the EDC system's build correctly reflects the protocol requirements and performs as expected before actual subject data is entered.
Question 2: Under GDPR, which principle requires that personal data collected in an EDC system be limited to what is necessary for the specified purpose?
- Data integrity
- Data minimization (Correct answer)
- Data portability
- Purpose limitation
Correct answer: Data minimization
GDPR's data minimization principle mandates that only the minimum amount of personal data necessary for the trial's stated purpose be collected.
Question 3: Which of the following is a key advantage of EDC over paper-based data collection in multi-site clinical trials?
- Eliminates the need for source document verification
- Provides real-time central monitoring of data completeness and quality (Correct answer)
- Removes the requirement for IRB oversight
- Eliminates the need for informed consent
Correct answer: Provides real-time central monitoring of data completeness and quality
EDC enables sponsors and CROs to monitor data quality and completeness across all sites in real time, supporting risk-based monitoring strategies.
Question 4: When a data manager performs 'medical coding' within or alongside an EDC system, what is the primary tool used to code adverse events?
- SNOMED-CT
- MedDRA (Medical Dictionary for Regulatory Activities) (Correct answer)
- ICD-10-CM
- CPT codes
Correct answer: MedDRA (Medical Dictionary for Regulatory Activities)
MedDRA is the internationally recognized medical terminology dictionary used to code adverse events and medical history in clinical trial databases.
Question 5: A site coordinator changes a previously entered lab value and provides a reason for the change. In a compliant EDC system, the original value should be:
- Permanently deleted to prevent confusion
- Retained in the audit trail alongside the corrected value and reason (Correct answer)
- Moved to a separate archive database
- Overwritten only if authorized by the PI
Correct answer: Retained in the audit trail alongside the corrected value and reason
21 CFR Part 11 and GCP require that original entries are never deleted; the audit trail must preserve the original value, the change, and the reason.
Question 6: In EDC configuration, a 'skip logic' or 'branching logic' rule is used to:
- Randomize subjects to treatment groups
- Hide or show eCRF fields based on responses to previous questions (Correct answer)
- Encrypt data during storage
- Automatically generate patient narratives
Correct answer: Hide or show eCRF fields based on responses to previous questions
Skip logic dynamically shows or hides form fields based on previous answers, preventing irrelevant data entry and reducing errors.
Question 7: What is the significance of an EDC system being '21 CFR Part 11 compliant' for FDA-regulated trials?
- It means the system is free to use with no licensing costs
- It means electronic records and signatures are legally equivalent to paper records and handwritten signatures (Correct answer)
- It exempts the trial from GCP inspections
- It means the EDC vendor is FDA-approved
Correct answer: It means electronic records and signatures are legally equivalent to paper records and handwritten signatures
21 CFR Part 11 compliance means the electronic records and electronic signatures generated by the system are legally accepted by the FDA as equivalent to traditional paper records.
CCDM Electronic Data Capture 3
What is the primary purpose of a User Acceptance Testing (UAT) phase before an EDC system goes live?