Clinical Research Coordinator Certification Quiz

1. Who is responsible for ensuring that the investigator understands a clinical trial?

The Study Participant

The FDA

The Sponsor

The IRB

The Sponsor is responsible for providing the necessary information to the investigator to ensure they understand the clinical trial protocol and procedures. The FDA is a regulatory agency overseeing the trial, the IRB is responsible for protocol review, and the study participant is not tasked with ensuring the investigator's understanding.

Explanation

The Sponsor is responsible for providing the necessary information to the investigator to ensure they understand the clinical trial protocol and procedures. The FDA is a regulatory agency overseeing the trial, the IRB is responsible for protocol review, and the study participant is not tasked with ensuring the investigator's understanding.

2. What is the minimum number of Institutional Review board (IRB) members?

3

4

6

5

According to regulations, the minimum number of Institutional Review board (IRB) members is 5 to ensure diverse perspectives and adequate review processes.

Explanation

According to regulations, the minimum number of Institutional Review board (IRB) members is 5 to ensure diverse perspectives and adequate review processes.

3. The initial drug dose is 110mg/m2. Due to toxicity, the drug needs to be decreased by 30%. The new dosage would be?

83

91

77

100

To calculate the new dosage after a 30% decrease, you can multiply the initial dosage by 0.7 (100% - 30% = 70%). Therefore, 110mg/m2 * 0.7 = 77mg/m2.

Explanation

To calculate the new dosage after a 30% decrease, you can multiply the initial dosage by 0.7 (100% - 30% = 70%). Therefore, 110mg/m2 * 0.7 = 77mg/m2.

4. Which of the following members is not included in the International Conference on Harmonization (ICH)?

The European Union (EU)

South America

Australia

Japan

The ICH is a harmonization initiative involving regulatory authorities and pharmaceutical industry representatives from the EU, the US, Japan, and other relevant countries, but does not include South America as a member.

Explanation

The ICH is a harmonization initiative involving regulatory authorities and pharmaceutical industry representatives from the EU, the US, Japan, and other relevant countries, but does not include South America as a member.

5. Significant risk device is defined as an investigational device that is:

All of the above

Intended as an implant and presents a potential for minor risk to the health, safety, or welfare of a subject

Used for cosmetic purposes and presents a potential risk to the health, safety, or welfare of a subject

For entertainment purposes only and presents a potential for minor risk to the health, safety, or welfare of a subject

In order to be classified as a significant risk device, the investigational device must meet all the criteria mentioned in options a, b, and c. Therefore, the correct answer is d. all of the above.

Explanation

In order to be classified as a significant risk device, the investigational device must meet all the criteria mentioned in options a, b, and c. Therefore, the correct answer is d. all of the above.