Introduction to Certified Clinical Research Associate Flashcards

Which document defines the objectives, design, methodology, statistical considerations, and organization of a clinical trial?

Answer: The clinical trial protocol

The clinical trial protocol is the master document that provides the scientific rationale, objectives, design, methodology, and statistical plan for the study.

Under GCP, which of the following is the investigator's responsibility with respect to the investigational product (IP)?

Answer: Maintaining accountability records for receipt, use, and disposition of the IP

Investigators must maintain accurate accountability records for all investigational product received, dispensed, used, and returned or destroyed.

What is the purpose of the Investigator's Brochure (IB)?

Answer: To provide the clinical and non-clinical data on the investigational product relevant to its study in humans

The IB compiles all relevant preclinical and clinical data about the investigational product to guide safe and appropriate conduct of the trial.

Which of the following best describes a 'serious adverse event' (SAE) per ICH E2A?

Answer: Any adverse event that results in death, is life-threatening, requires hospitalization, or causes persistent disability

An SAE is defined by ICH E2A as any adverse event that results in death, is life-threatening, requires inpatient hospitalization, causes persistent significant disability, or is a congenital anomaly.

How long after its occurrence must a sponsor report a suspected unexpected serious adverse reaction (SUSAR) to the FDA for fatal or life-threatening events?

Answer: Within 7 calendar days

Fatal or life-threatening SUSARs must be reported to the FDA within 7 calendar days of the sponsor's first receipt of information, per 21 CFR 312.32.

In the context of a clinical trial, what does 'randomization' achieve?

Answer: It reduces selection bias by ensuring subjects are assigned to treatment groups by chance

Randomization minimizes selection bias and helps ensure that treatment groups are comparable by assigning subjects to groups by chance rather than choice.

What is the primary regulatory framework governing the protection of human research subjects in federally funded research in the United States?

Answer: The Common Rule (45 CFR Part 46)

The Common Rule (45 CFR Part 46) is the primary federal regulation for protecting human subjects in research conducted or supported by federal agencies.