CPI Clinical Documentation & Records 2 — Questions and Answers
Question 1: When a source document error is discovered in a clinical trial, the correct procedure is to:
- Delete the original entry and rewrite it
- Cross out the error with a single line, initial, date, and note the reason (Correct answer)
- Use correction fluid to cover the mistake before writing the correction
- Leave the error and add a sticky note explaining it
Correct answer: Cross out the error with a single line, initial, date, and note the reason
ICH GCP requires that corrections preserve the original entry by crossing it out with a single line, then initialing, dating, and providing a reason for the correction.
Question 2: A case report form (CRF) entry differs from the source document. Which action should the clinical investigator take first?
- Amend the CRF to match the source document and notify the sponsor (Correct answer)
- Destroy the CRF and reissue a blank form
- Amend the source document to match the CRF
- Report the discrepancy to the FDA without notifying the sponsor
Correct answer: Amend the CRF to match the source document and notify the sponsor
Discrepancies between CRFs and source documents must be corrected in the CRF to reflect the source data, and the sponsor must be notified per GCP requirements.
Question 3: Which of the following is considered a source document in a clinical trial?
- The completed CRF submitted to the sponsor
- The protocol synopsis distributed to IRB members
- The original hospital medical record containing lab results (Correct answer)
- The sponsor's monitoring visit report
Correct answer: The original hospital medical record containing lab results
Source documents are original records from which CRF data are transcribed, including hospital charts, lab reports, and clinic notes.
Question 4: Under 21 CFR Part 312, how long must investigators retain clinical trial records after the investigation is discontinued or completed?
- 2 years
- 5 years
- At least 2 years following the date a marketing application is approved, or 2 years after the investigation is discontinued (Correct answer)
- 10 years
Correct answer: At least 2 years following the date a marketing application is approved, or 2 years after the investigation is discontinued
21 CFR 312.62 requires investigators to retain records for at least 2 years after approval of a marketing application or 2 years after discontinuation of the investigation.
Question 5: An electronic data capture (EDC) system audit trail is important in clinical trials because it:
- Allows sponsors to delete unfavorable data entries
- Provides a chronological record of all data changes, who made them, and when (Correct answer)
- Replaces the need for source document verification
- Is only required for Phase III trials
Correct answer: Provides a chronological record of all data changes, who made them, and when
Audit trails document the history of data entry and changes to ensure data integrity and allow reconstruction of the sequence of events.
Question 6: The ALCOA principle in clinical data documentation stands for:
- Accurate, Legible, Contemporaneous, Original, Attributable
- Accountable, Linked, Complete, Organized, Auditable
- Attributable, Legible, Contemporaneous, Original, Accurate (Correct answer)
- Auditable, Logical, Consistent, Objective, Accountable
Correct answer: Attributable, Legible, Contemporaneous, Original, Accurate
ALCOA stands for Attributable, Legible, Contemporaneous, Original, and Accurate — the five core data quality standards in GCP.
Question 7: A subject's informed consent form was signed after the first study procedure was performed. This represents:
- A minor protocol deviation that does not need to be reported
- A serious protocol deviation that must be documented and reported to the IRB and sponsor (Correct answer)
- An acceptable practice if the subject later verbalizes consent
- Standard procedure when procedures are time-sensitive
Correct answer: A serious protocol deviation that must be documented and reported to the IRB and sponsor
Performing study procedures before obtaining informed consent is a serious protocol deviation requiring documentation and reporting to both the IRB and sponsor.
CPI Clinical Documentation & Records 2
When a source document error is discovered in a clinical trial, the correct procedure is to: