CTA Data Collection & CRF Management 3 — Questions and Answers
Question 1: Under 21 CFR Part 11, electronic signatures in eCRF systems must include which of the following components?
- Only the signer's printed name and date
- The printed name of the signer, the date and time of signing, and the meaning of the signature (Correct answer)
- A wet ink signature scanned and uploaded to the system
- A unique password known only to the investigator
Correct answer: The printed name of the signer, the date and time of signing, and the meaning of the signature
21 CFR Part 11 requires electronic signatures to include the signer's printed name, the date and time of signing, and the meaning of the signature (e.g., approval, authorship).
Question 2: A site receives a CRF completion guideline stating 'data must be entered within 5 business days of the visit.' This requirement is MOST likely found in the:
- Study protocol
- Informed consent form
- Data management plan or study-specific eCRF completion guidelines (Correct answer)
- Investigator brochure
Correct answer: Data management plan or study-specific eCRF completion guidelines
CRF completion timelines and data entry windows are typically specified in the data management plan (DMP) or study-specific CRF completion guidelines provided by the sponsor.
Question 3: When a laboratory value in the eCRF is flagged with an automatic system query for being outside normal range, the site coordinator should:
- Immediately change the value to bring it within normal range
- Verify the value against the source document and respond to the query confirming accuracy or correcting the error (Correct answer)
- Ignore the query if the investigator believes the value is correct
- Contact the IRB before responding to any lab queries
Correct answer: Verify the value against the source document and respond to the query confirming accuracy or correcting the error
Automatic range-check queries require site staff to verify the entered value against the original lab report (source document) and respond with a confirmation or correction.
Question 4: Which of the following is an example of a protocol deviation that must be documented in the CRF?
- A subject arriving 10 minutes late to a scheduled visit
- A subject taking the study medication one day later than the protocol-specified window (Correct answer)
- A subject asking to reschedule a future visit
- A site coordinator changing shift assignments
Correct answer: A subject taking the study medication one day later than the protocol-specified window
Taking study medication outside the protocol-specified dosing window is a protocol deviation that must be documented in the appropriate CRF page and reported per protocol requirements.
Question 5: In direct data capture (DDC), data is entered into the eCRF without paper source documents. Which of the following is a key validation requirement for DDC systems?
- The eCRF must be printed and signed after each visit
- The system must be validated per 21 CFR Part 11 and the data must still be attributable, legible, contemporaneous, original, and accurate (Correct answer)
- Data must be re-entered by a second person for verification
- DDC systems must use paper backup during each site visit
Correct answer: The system must be validated per 21 CFR Part 11 and the data must still be attributable, legible, contemporaneous, original, and accurate
DDC systems must be validated and meet 21 CFR Part 11 requirements; the eCRF itself serves as the source record, so ALCOA principles still apply.
Question 6: A sponsor's CRF data cut reveals that 15% of subjects have missing 'prior medication' data. What is the MOST appropriate corrective action?
- Remove those subjects from the intent-to-treat population
- Issue targeted queries to all affected sites requesting completion or explanation of missing data (Correct answer)
- Carry forward the last known medication data for statistical analysis
- Report the missing data to the FDA as a protocol deviation
Correct answer: Issue targeted queries to all affected sites requesting completion or explanation of missing data
Missing CRF data should be addressed through queries to the originating sites, requesting either completion of the missing information or a documented reason (e.g., 'not collected').
Question 7: A CTA notices that the same site coordinator has been entering data for multiple subjects simultaneously using different browser tabs in the eCRF. What concern does this raise?
- No concern — parallel entry is an efficient practice
- Risk of data entry errors due to cross-contamination of subject data across tabs (Correct answer)
- A violation of the protocol's randomization procedures
- A breach of the investigator's financial disclosure obligations
Correct answer: Risk of data entry errors due to cross-contamination of subject data across tabs
Entering data for multiple subjects simultaneously across browser tabs increases the risk of entering the wrong data for the wrong subject, compromising data integrity.
CTA Data Collection & CRF Management 3
Under 21 CFR Part 11, electronic signatures in eCRF systems must include which of the following components?