CCDM Electronic Data Capture 2 — Questions and Answers
Question 1: Which 21 CFR Part 11 requirement ensures that electronic records cannot be altered without detection?
- Audit trails that capture all changes with timestamp and user identity (Correct answer)
- Password-protected login screens
- Regular data backups to secure servers
- Role-based access control lists
Correct answer: Audit trails that capture all changes with timestamp and user identity
21 CFR Part 11 requires audit trails that record every change to electronic records, including who made the change and when.
Question 2: In an EDC system, what is the purpose of a 'data validation check' at the point of entry?
- To encrypt data during transmission
- To flag out-of-range or logically inconsistent values immediately (Correct answer)
- To notify the sponsor of new data entries
- To randomize subject allocation
Correct answer: To flag out-of-range or logically inconsistent values immediately
Point-of-entry data validation checks catch errors in real time by flagging values that fall outside expected ranges or violate logical rules.
Question 3: A site enters a blood pressure reading of 450/200 mmHg. The EDC system generates an automatic query. This type of query is called a:
- Manual query
- Programmatic or system-generated query (Correct answer)
- Third-party query
- Sponsor-initiated query
Correct answer: Programmatic or system-generated query
Programmatic or system-generated queries are automatically created by the EDC system when data violates pre-programmed edit checks.
Question 4: What does 'database lock' signify in the context of an EDC-managed clinical trial?
- The EDC vendor has terminated service
- All data has been verified and the database is frozen for statistical analysis (Correct answer)
- Randomization has been unblinded
- The site has been closed for enrollment
Correct answer: All data has been verified and the database is frozen for statistical analysis
Database lock means all data cleaning is complete, the database is verified, and it is frozen to prevent further changes before statistical analysis.
Question 5: Which user role in an EDC system is typically responsible for responding to data queries raised by the sponsor or CRO?
- System administrator
- Biostatistician
- Site data entry operator or clinical research coordinator (Correct answer)
- Independent Data Monitoring Committee member
Correct answer: Site data entry operator or clinical research coordinator
The site's clinical research coordinator or data entry operator is responsible for reviewing and resolving queries on their entered data.
Question 6: In EDC, 'eCRF completion guidelines' are primarily designed to:
- Define the statistical analysis plan
- Ensure consistent and accurate data entry across all participating sites (Correct answer)
- Configure the EDC system's server infrastructure
- Randomize subjects to treatment arms
Correct answer: Ensure consistent and accurate data entry across all participating sites
eCRF completion guidelines provide standardized instructions to site staff on how to correctly enter data, promoting consistency across sites.
Question 7: A sponsor wants to allow sites to enter data offline and synchronize when connectivity is restored. What EDC feature enables this?
- Single sign-on (SSO)
- Offline data capture with synchronization capability (Correct answer)
- Two-factor authentication
- Real-time data replication
Correct answer: Offline data capture with synchronization capability
Offline data capture allows site staff to enter data without internet connectivity, with automatic synchronization to the central server once connection is re-established.
CCDM Electronic Data Capture 2
Which 21 CFR Part 11 requirement ensures that electronic records cannot be altered without detection?