CCRA Certified Clinical Research Study 3

Question 1

During a routine monitoring visit, the CRA notices the investigational product (IP) storage temperature log shows a 4-hour excursion outside the specified range. What is the MOST appropriate next step?

Accepted Answer

Quarantine the affected IP and notify the sponsor for disposition instructions

Answer

Affected IP must be quarantined pending sponsor assessment; only the sponsor/manufacturer can determine whether the product remains usable.

Question 2

Which element is NOT required to be included in an informed consent form according to 21 CFR Part 50.25?

Accepted Answer

The subject's social security number

Answer

21 CFR 50.25 lists required ICF elements, and a subject's social security number is not among them; collecting it would be a privacy concern.

Question 3

A sponsor's risk-based monitoring plan categorizes Site A as 'high risk.' Which combination of factors most likely triggered this designation?

Accepted Answer

New site, high enrollment rate, and multiple protocol deviations

Answer

Risk-based monitoring assigns higher risk to sites with inexperience, rapid enrollment, and a history of deviations — indicators of increased error probability.

Question 4

Under GCP, what does the term 'blinding/masking' refer to in the context of a randomized controlled trial?

Accepted Answer

Preventing one or more parties from knowing the treatment assignment

Answer

Blinding prevents knowledge of treatment assignment by subjects, investigators, or both to reduce bias in a randomized controlled trial.

Question 5

When must a protocol deviation be reported to the IRB according to standard GCP practice?

Accepted Answer

Only deviations that affect subject safety or data integrity require IRB reporting per IRB SOPs

Answer

IRB reporting requirements vary by institution, but deviations that affect subject safety, rights, or data integrity generally require prompt IRB notification per site SOPs.

CCRA - Certified Clinical Research Associate Practice Test

CCRA - Certified Clinical Research Associate Practice Test

CCRA Certified Clinical Research Study 3