FREE Certified Clinical Research Associate Questions and Answers

Question 1

What is the name of the document that the site must sign and date before making a QV appointment?

Accepted Answer

A CDA

Answer

MONITORING REPORT

Answer

REMOTE VISIT

Answer

A PLACEBO

Question 2

Define pharmacokinetics.

Accepted Answer

The study of drug movement throughout the body

Answer

Via Web

Answer

The monitoring guidelines are ICH-GCP Guidelines and FDA Guidelines

Answer

The normal care provided per the sites guidelines

Question 3

What phase is the patient NOT healthy?

Accepted Answer

At phase 2

Answer

At phase 4

Answer

At phase 98

Answer

At phase 8

Question 4

Standard of care (SOC) is defined as.

Accepted Answer

The normal care provided per the sites guidelines

Answer

To monitor clinical trials

Answer

Clinical monitor, trial monitor, or site manager

Answer

The monitoring guidelines are ICH-GCP Guidelines and FDA Guidelines

Question 5

Who is present when a SIV occurs?

Accepted Answer

During a SIV the PI, Sub I, SC, and other key staff are present.

Answer

Clinical research organization

Answer

Oncology, Cardiology, General Medicine

Answer

Any untoward event that may or may not be related to the study drug that was not originally identified within the subjects medical history

Question 6

What is Clinical trial management system (CTMS)?

Accepted Answer

CRA will enter trip reports, track protocol deviations, house all site information

Answer

Whether humans and animals show a significantly different response to the drug and to establish safe clinical dosage range

Answer

An application filed with the FDA after completion of pre-clinical and prior to human testing

Answer

Via telephone

Question 7

What is a doctor's alternate name in the clinical field?

Accepted Answer

Investigator

Answer

Sponsor

Answer

Randomization

Answer

Monitor