CTA Data Collection & CRF Management 2 — Questions and Answers
Question 1: 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?
- Delete the entry and re-enter the correct value
- Contact the sponsor's data management team before making any changes
- Create an audit trail entry explaining the error, then correct the value without notifying anyone
- Cross out the error in the paper source, initial, date, and enter the correct value with reason for change (Correct answer)
Correct 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.
Question 2: Which of the following best describes a 'data clarification form' (DCF) in clinical trial data management?
- A form used to document adverse events during the trial
- A query generated by the sponsor or CRO requesting the site to clarify or correct data discrepancies (Correct answer)
- A regulatory submission document sent to the FDA
- A consent form addendum clarifying protocol changes
Correct 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.
Question 3: In an eCRF system, what does 'audit trail' refer to?
- The final cleaned dataset submitted to regulatory authorities
- A chronological record of all data entries, modifications, and deletions with user identification and timestamps (Correct answer)
- A summary of protocol deviations identified during the trial
- A log of all site personnel who accessed the study database
Correct 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.
Question 4: A subject misses a scheduled visit. How should the missed visit data be recorded in the CRF?
- Leave all fields blank for that visit
- Document 'not done' or 'missed visit' with the reason in the appropriate CRF fields (Correct answer)
- Copy forward data from the previous visit to maintain continuity
- Delete the visit from the CRF schedule entirely
Correct 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.
Question 5: Which principle underlies the requirement that source data must be ALCOA-compliant?
- Automated, Legible, Consistent, Original, Accessible
- Attributable, Legible, Contemporaneous, Original, Accurate (Correct answer)
- Authorized, Linked, Correctable, Organized, Archived
- Auditable, Licensed, Contemporaneous, Organized, Authenticated
Correct 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.
Question 6: What is the appropriate action when a subject reports an adverse event that occurred between two scheduled visits?
- Record it only at the next scheduled visit
- Document it in the AE CRF page immediately with onset date and details (Correct answer)
- Wait until the event resolves before recording it
- Record it only if the event is related to the investigational product
Correct 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.
Question 7: A CTA is reviewing CRF completion rates before a monitoring visit. Which metric would BEST indicate a data quality concern?
- 100% query resolution rate
- High number of outstanding (open) queries older than 30 days (Correct answer)
- All CRF pages submitted within 7 days of the visit
- Zero protocol deviations reported
Correct 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.
CTA Data Collection & CRF Management 2
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?