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
A site coordinator discovers that a lab value was entered incorrectly in the eCRF three weeks ago. What is the FIRST step to correct this?
Answer: Cross out the error in the paper source, initial, date, and enter the correct value with reason for change
For paper CRF corrections, the standard is to cross out (single line), initial, date, and enter the corrected value with a reason — never erase or use correction fluid.
Which of the following best describes a 'data clarification form' (DCF) in clinical trial data management?
Answer: A query generated by the sponsor or CRO requesting the site to clarify or correct data discrepancies
A DCF (also called a query) is issued by the sponsor or CRO when data in the CRF appears inconsistent, incomplete, or unclear, requiring site clarification.
In an eCRF system, what does 'audit trail' refer to?
Answer: A chronological record of all data entries, modifications, and deletions with user identification and timestamps
An audit trail is a secure, computer-generated, time-stamped electronic record that allows reconstruction of the course of data entries and modifications by individual users.
A subject misses a scheduled visit. How should the missed visit data be recorded in the CRF?
Answer: Document 'not done' or 'missed visit' with the reason in the appropriate CRF fields
Missed visits must be documented in the CRF with the reason (e.g., 'subject missed visit') rather than leaving fields blank or copying prior data, ensuring data integrity.
Which principle underlies the requirement that source data must be ALCOA-compliant?
Answer: Attributable, Legible, Contemporaneous, Original, Accurate
ALCOA stands for Attributable, Legible, Contemporaneous, Original, and Accurate — the FDA-endorsed data quality standards for clinical trial records.
What is the appropriate action when a subject reports an adverse event that occurred between two scheduled visits?
Answer: Document it in the AE CRF page immediately with onset date and details
Adverse events must be recorded promptly as source data when reported, regardless of whether a scheduled visit has occurred, to ensure contemporaneous documentation.
A CTA is reviewing CRF completion rates before a monitoring visit. Which metric would BEST indicate a data quality concern?
Answer: High number of outstanding (open) queries older than 30 days
A large number of aged open queries indicates unresolved data discrepancies at the site, suggesting poor data quality management and potential source data verification issues.