CCRA Data Management and Source Document Verification 1 — Questions and Answers
Question 1: What qualifies as a 'source document' in a clinical trial?
- Only the Case Report Form (CRF)
- Original records and certified copies of original information including medical records, lab reports, and subject diaries (Correct answer)
- The protocol and amendments only
- Electronic data capture system printouts only
Correct answer: Original records and certified copies of original information including medical records, lab reports, and subject diaries
Source documents are original records from which subject data are first captured, including hospital records, clinic charts, laboratory notes, diaries, pharmacy records, and imaging results.
Question 2: In a clinical trial using an Electronic Data Capture (EDC) system, audit trails serve to:
- Eliminate the need for source document verification
- Record all data entries, changes, deletions, and the identity of the person making changes with timestamps (Correct answer)
- Automatically correct data entry errors
- Replace the paper CRF process entirely
Correct answer: Record all data entries, changes, deletions, and the identity of the person making changes with timestamps
EDC audit trails create an automatic, computer-generated, time-stamped record of all actions taken in the system, supporting data integrity and regulatory inspection readiness.
Question 3: A 'certified copy' of a source document is acceptable when:
- It is created by the CRA during the monitoring visit
- It is a verified copy that has been confirmed as an exact copy of the original through a documented process (Correct answer)
- The original document has been destroyed
- It is signed only by the CRA
Correct answer: It is a verified copy that has been confirmed as an exact copy of the original through a documented process
A certified copy is a copy verified to be a true and accurate copy of the original through a documented certification process, and it may be retained in place of the original when needed.
Question 4: What does 'query resolution' involve in clinical data management?
- Resolving IRB approval queries from site staff
- Identifying, clarifying, and correcting data discrepancies or missing data in CRFs through a formal communication process (Correct answer)
- Answering protocol questions from investigators
- Resolving financial payment disputes between sponsor and sites
Correct answer: Identifying, clarifying, and correcting data discrepancies or missing data in CRFs through a formal communication process
Query resolution is the process by which data managers or CRAs flag data issues in the CRF/EDC, sites investigate and correct the data, and the resolution is documented with an explanation.
Question 5: What is the regulatory requirement for corrections made to paper CRF data?
- Use white-out to remove the error and write the correct value
- Draw a single line through the error, write the correct value, initial, and date the correction (Correct answer)
- Delete the entire page and resubmit a clean CRF
- Corrections must be made only by the CRA
Correct answer: Draw a single line through the error, write the correct value, initial, and date the correction
GCP requires that CRF corrections preserve the original entry; the correct method is a single line through the error so the original is still legible, with the correction, date, and initials of the person making the change.
Question 6: When EDC is used as the source of truth and data are entered directly into the EDC system without prior paper records, these data are called:
- Secondary data
- eSource data (Correct answer)
- Derived data
- Transferred data
Correct answer: eSource data
eSource refers to clinical trial data captured directly in electronic systems (e.g., EDC, EHR) as the original source, without an intermediate paper record being created.
CCRA Data Management and Source Document Verification 1
What qualifies as a 'source document' in a clinical trial?