Source Documentation and Data Flashcards
7 cards from real SOCRA practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Source Documentation and Data flashcards as text
Under 21 CFR Part 11, which requirement applies to electronic records used as source documents?
Answer: They must have audit trails that capture who made changes and when, and electronic signatures must be linked to the record
21 CFR Part 11 mandates secure audit trails and electronic signatures that are permanently linked to the electronic record to ensure data integrity.
What is the primary purpose of an audit trail in an electronic data capture (EDC) system?
Answer: To track all changes to data fields, including who made the change, what was changed, and when
Audit trails provide a secure, computer-generated record of all data modifications, supporting data integrity and regulatory accountability.
When is direct data entry (DDE) into an EDC system considered acceptable as source data?
Answer: When the site has documented procedures establishing the EDC as the source and no prior paper record was created
DDE into EDC is acceptable as source when the site's SOPs designate the EDC as the source and data is entered contemporaneously without a prior paper record.
A site uses an electronic health record (EHR) system. The monitor wants to verify subject data. Which approach is most appropriate?
Answer: The site should provide monitor access to relevant EHR fields in compliance with local privacy regulations and the clinical trial agreement
Monitor access to EHR records must balance GCP source data verification requirements with local privacy laws and the agreements governing data access.
Which statement about electronic signatures under 21 CFR Part 11 is correct?
Answer: Electronic signatures must be unique to the individual and require at least two distinct identification components for first use
Part 11 requires electronic signatures to be unique to one individual and executed with at least two distinct components (e.g., user ID and password) upon first signing.
What is meant by 'system validation' in the context of electronic systems used for clinical trial data?
Answer: A documented process to confirm the system consistently produces results meeting predetermined specifications and quality attributes
Computer system validation (CSV) ensures electronic systems perform as intended and meet regulatory requirements through documented testing and review.
When a data query is raised in an EDC system, what should the site do before resolving it?
Answer: Review the original source document, confirm the correct value, and document the reason for any data change
Query resolution must be source-document-driven; the site must verify the original record and document justification for any correction to maintain data integrity.