Introduction to Certified Clinical Research Associate Flashcards

During a monitoring visit, the CRA finds that the investigator site file (ISF) is missing the latest protocol amendment signed by the PI. What action should the CRA take?

Answer: Document the missing document as a finding and request that the site obtain and file it promptly

A missing signed protocol amendment in the ISF is a documentation deficiency that must be documented in the monitoring report and remediated by the site.

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

Answer: To independently review accumulating safety and efficacy data and recommend continuation, modification, or termination of the trial

A DSMB is an independent committee that periodically reviews unblinded data to protect the safety of trial participants and the validity of the trial.

Which regulation requires sponsors to promptly review all information relevant to the safety of the investigational drug received from any source?

Answer: 21 CFR 312.32

21 CFR 312.32 specifically governs IND safety reports and requires sponsors to review all safety information and report serious unexpected adverse drug reactions.

A Phase I clinical trial primarily evaluates:

Answer: Safety, tolerability, pharmacokinetics, and maximum tolerated dose in a small group of subjects

Phase I trials focus on safety, tolerability, PK/PD properties, and dose escalation, typically in 20–100 healthy volunteers or patients.

What is the meaning of 'blinding' (or 'masking') in a clinical trial?

Answer: A procedure to prevent participants and/or investigators from knowing which treatment is being administered

Blinding prevents knowledge of treatment assignment to reduce bias; single-blind masks the subject, while double-blind masks both subject and investigator.

An informed consent form must be written at a reading level that is understandable to the subject. According to FDA guidance, this is generally at approximately what grade level?

Answer: 6th to 8th grade reading level

FDA guidance recommends that consent forms be written at a 6th to 8th grade reading level to ensure comprehension by the general population.

What is a 'protocol deviation' versus a 'protocol violation' in clinical research?

Answer: A deviation is a minor, unplanned departure from the protocol; a violation is a more serious departure that may affect subject safety or data integrity

Deviations are minor unplanned departures from the protocol, while violations are serious departures that may impact subject safety or data validity and require prompt reporting.