CCRA Introduction to Certified Clinical Research Associate 4

Question 1

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

Accepted Answer

The clinical trial protocol

Answer

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

Question 2

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

Accepted Answer

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

Answer

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

Question 3

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

Accepted Answer

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

Answer

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

Question 4

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

Accepted Answer

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

Answer

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.

Question 5

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?

Accepted Answer

Within 7 calendar days

Answer

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.

CCRA - Certified Clinical Research Associate Practice Test

CCRA - Certified Clinical Research Associate Practice Test

CCRA Introduction to Certified Clinical Research Associate 4