Certified Clinical Research Study Flashcards

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?

Answer: Quarantine the affected IP and notify the sponsor for disposition instructions

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

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

Answer: The subject's social security number

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.

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

Answer: New site, high enrollment rate, and multiple protocol deviations

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

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

Answer: Preventing one or more parties from knowing the treatment assignment

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

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

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

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

What is the primary purpose of the Declaration of Helsinki?

Answer: To provide ethical principles for medical research involving human subjects

The Declaration of Helsinki is a foundational ethical document developed by the World Medical Association to guide researchers conducting studies involving human participants.

A CRA notices that a site coordinator has been signing consent forms as the 'person obtaining consent' without being listed on the site's delegation of authority log. What is this an example of?

Answer: An unauthorized activity constituting a GCP violation

All personnel performing delegated trial tasks must be listed on the delegation of authority log; undocumented delegation is a GCP violation regardless of subsequent countersignature.