Certified Clinical Research Associate Flashcards

A subject who previously signed informed consent now lacks decision-making capacity due to an adverse event. Who may provide continued consent for their participation?

Answer: A legally authorized representative (LAR) as defined by applicable law

When a subject loses capacity, a legally authorized representative defined by applicable law and IRB-approved procedures may provide surrogate consent.

Which ICH E6(R2) addendum concept introduced the idea of proportionate monitoring based on risk?

Answer: Risk-based monitoring (RBM) focusing oversight on critical data and processes

ICH E6(R2) introduced risk-based monitoring, directing CRA resources toward critical processes and data that have the greatest impact on subject safety and data integrity.

At a closeout visit, the CRA instructs site staff on document retention. According to ICH E6 and FDA regulations, trial records must generally be retained for a minimum of how many years after the last approval of a marketing application?

Answer: 2 years

FDA 21 CFR 312.62 requires investigators to retain records for at least 2 years after the last approval of a marketing application or 2 years after the investigation is discontinued.

A CRA identifies that a site has been using an outdated version of the informed consent form for the past three months. What is the appropriate classification of this finding?

Answer: A serious protocol deviation because it may have affected subject rights

Using an outdated informed consent form is a serious protocol deviation because subjects may not have been informed of updated risk information, potentially affecting their rights and safety.

What is the purpose of a Data Safety Monitoring Board (DSMB) in a clinical trial?

Answer: To independently monitor accumulating trial data and recommend stopping or modifying the trial if warranted

A DSMB is an independent committee that reviews accumulating efficacy and safety data and can recommend trial modifications or early termination to protect subjects.

According to 21 CFR Part 50, which of the following elements is REQUIRED to be included in an informed consent document?

Answer: A description of any reasonably foreseeable risks or discomforts

21 CFR 50.25 requires informed consent documents to describe reasonably foreseeable risks or discomforts to the subject.

A sponsor-CRA learns that an investigator has not reported a serious adverse event (SAE) to the IRB within the required timeframe. What must the CRA do?

Answer: Document the finding, notify the investigator of the obligation, and escalate to sponsor management per the monitoring plan

The CRA must document the deviation, remind the investigator of their reporting obligation, and escalate to sponsor management as specified in the monitoring plan.