CTA Data Collection & CRF Management 3

Question 1

Under 21 CFR Part 11, electronic signatures in eCRF systems must include which of the following components?

Accepted Answer

The printed name of the signer, the date and time of signing, and the meaning of the signature

Answer

21 CFR Part 11 requires electronic signatures to include the signer's printed name, the date and time of signing, and the meaning of the signature (e.g., approval, authorship).

Question 2

A site receives a CRF completion guideline stating 'data must be entered within 5 business days of the visit.' This requirement is MOST likely found in the:

Accepted Answer

Data management plan or study-specific eCRF completion guidelines

Answer

CRF completion timelines and data entry windows are typically specified in the data management plan (DMP) or study-specific CRF completion guidelines provided by the sponsor.

Question 3

When a laboratory value in the eCRF is flagged with an automatic system query for being outside normal range, the site coordinator should:

Accepted Answer

Verify the value against the source document and respond to the query confirming accuracy or correcting the error

Answer

Automatic range-check queries require site staff to verify the entered value against the original lab report (source document) and respond with a confirmation or correction.

Question 4

Which of the following is an example of a protocol deviation that must be documented in the CRF?

Accepted Answer

A subject taking the study medication one day later than the protocol-specified window

Answer

Taking study medication outside the protocol-specified dosing window is a protocol deviation that must be documented in the appropriate CRF page and reported per protocol requirements.

Question 5

In direct data capture (DDC), data is entered into the eCRF without paper source documents. Which of the following is a key validation requirement for DDC systems?

Accepted Answer

The system must be validated per 21 CFR Part 11 and the data must still be attributable, legible, contemporaneous, original, and accurate

Answer

DDC systems must be validated and meet 21 CFR Part 11 requirements; the eCRF itself serves as the source record, so ALCOA principles still apply.

(CTA) Clinical Trial Associate Certification Practice Test

(CTA) Clinical Trial Associate Certification Practice Test

CTA Data Collection & CRF Management 3