Data Collection & CRF Management Flashcards
7 cards from real CTA practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Data Collection & CRF Management flashcards as text
Under 21 CFR Part 11, electronic signatures in eCRF systems must include which of the following components?
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).
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:
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.
When a laboratory value in the eCRF is flagged with an automatic system query for being outside normal range, the site coordinator should:
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.
Which of the following is an example of a protocol deviation that must be documented in the CRF?
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.
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?
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.
A sponsor's CRF data cut reveals that 15% of subjects have missing 'prior medication' data. What is the MOST appropriate corrective action?
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').
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?
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.