CPI Clinical Documentation & Records 2

Question 1

When a source document error is discovered in a clinical trial, the correct procedure is to:

Accepted Answer

Cross out the error with a single line, initial, date, and note the reason

Answer

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?

Accepted Answer

Amend the CRF to match the source document and notify the sponsor

Answer

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?

Accepted Answer

The original hospital medical record containing lab results

Answer

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?

Accepted Answer

At least 2 years following the date a marketing application is approved, or 2 years after the investigation is discontinued

Answer

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:

Accepted Answer

Provides a chronological record of all data changes, who made them, and when

Answer

Audit trails document the history of data entry and changes to ensure data integrity and allow reconstruction of the sequence of events.

(CPI) Certified Physician Investigator Practice Test

(CPI) Certified Physician Investigator Practice Test

CPI Clinical Documentation & Records 2