Certification Exam Prep

Question 1

Which entity is primarily charged with considering subject rights and well-being during clinical trials?

Answer 1

IRB / IEC

Question 2

Thirty-two subjects are enrolled in a neurology study in which 50 subjects eventually will be enrolled. The CRC notes that 25 of these 32 subjects have developed a cough. The CRC should now do which of the following actions.

• Report the observation to the sponsor.
• Ask the IRB/IEC permission to continue the study.
• Inform the CRA at the next monitoring visit.
• Modify the screening questionnaire to ask about cough.

Answer 2

Report the observation to the sponsor

Question 3

A CRA noticed that a subject showed clinically significant liver function test abnormalities on the subject’s last study visit. The test was conducted at a local laboratory not listed in the protocol. The CRA then discovered that the local laboratory was not accredited. What should the CRA do first?

• Recommend suspending study activities at the site.
• Recommend admitting the subject to the hospital.
• Request a repeat liver function test at an accredited laboratory.
• Request subjects’ randomization codes for the coordinator at the site.

Answer 3

Request a repeat liver function test at an accredited laboratory.

Question 4

An Investigator’s Brochure should contain which of the following about an investigational product?

1. Chemical name
2. Chemical synthesis procedures
3. Instructions for destruction of the investigational product
4. Adverse drug reactions
   - 1 and 2 only
   - 2 and 3 only
   - 3 and 4 only
   - 1 and 4 only

Answer 4

1 and 4 only

Question 5

The 3 cognitive levels used in the exam are:

• Recall, Understanding, Analysis
• Recall, Evaluation, Creating
• Recall, Remembering, Understanding
• Recall, Application, Analysis

Answer 5

Recall, Application, Analysis

Question 6

The following are guidelines tested during the certification exam: (Select all that apply)

• The Nuremberg Code
• ICH GCP (E6)
• The Belmont Report
• The Declaration of Helsinki
• ICH E2A

Answer 6

• ICH GCP (E6)
• The Declaration of Helsinki
• ICH E2A