Preparing for the Exam

Content areas on the examination that deal with topics concerning your daily job requirements should not require extensive study on your part; it is anticipated that this is part of your working knowledge. Content areas appearing on the examination that are not part of your daily job requirements may require some research and study. For instance, if you do not deal with Institutional Review Boards (IRB), you will want to study the requirements of this aspect of clinical research.

Please remember that the examination assesses your knowledge and understanding of the United States Code of Federal Regulations and the International Conference of Harmonisation E6 & E2A Guidelines. It does not assess state, local, provincial, Ministry of Health, or institutional policy.

Please see the Exam Outline to review the list of the ethical principles, FDA regulations and forms, and ICH guidelines that are included in the scope of the exam.

Explanation of Hierarchy of Federal Food, Drug, and Cosmetic Act vs. Regulations vs. Guidance

The Federal Food, Drug, and Cosmetic Act (FD&C Act) is United States (US) federal law enacted by Congress (statutory law). It and other federal laws establish the legal framework within which the US Food and Drug Administration (FDA) operates. The FD&C Act can be found in the United States Code (U.S.C), which contains all general and permanent U.S. laws, beginning at 21 U.S.C. 301.

The FDA develops regulations based on the laws set forth in the FD&C Act or other laws under which FDA operates. FDA follows the procedures required by the Administrative Procedure Act, another federal law, to issue FDA regulations. FDA regulations are also federal laws, but they are not part of the FD&C Act. The regulations are legally binding. (administrative law)

FDA guidance describes the agency’s current thinking on a regulatory issue. Guidance is not legally binding on the public or FDA. The Good Guidance Practice regulation can be found at 21 CFR 10.115

21 CFR 10.115 (b) What is a guidance document? (1) Guidance documents are documents prepared for FDA staff, applicants/sponsors, and the public that describe the agency's interpretation of or policy on a regulatory issue.

Sample Questions

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

a. 3
b. 5
c. 6
d.10

2. In a non-emergency situation, under which of the following conditions, if any, may subjects be enrolled into a study prior to IRB/IEC approval?

a. The investigator provides his/her written approval
b. The study drug has an FDA approved marketing application
c. The FDA provides written approval of the IND
d. Subjects cannot be enrolled until IRB/IEC approval has been obtained

3. The responsibility for ensuring that the investigator understands a clinical trial lies with:

a. The FDA
b. The IRB
c. The Sponsor
d. The Coordinator

4. A subject has been enrolled on a study and was randomized to the non-treatment arm. The protocol outlines study procedures for all subjects to be performed within one week of enrollment. Which of the following statements about this case is correct?

a. This subject does not need to undergo any of the study procedures since the subject is enrolled on the non-treatment arm
b. This subject should undergo all study procedures as outlined in the protocol
c. This subject only needs to undergo the study procedures that pertain specifically to the subject
d. This subject can undergo the study procedures whenever it is convenient

Answers: 1) b, 2) d, 3) c, 4)b, 5) d, 6) c, 7) a, 8) d

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

a. Intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a subject.
b. Purported or represented to be for a use in supporting or sustaining human life and presents a potential risk to the health, safety, or welfare of a subject.
c. For a use of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of human health and presents a potential for serious risk to the health, safety, or welfare of a subject.
d. All the above

6. With respect to IRB/IEC membership, both the FDA and the ICH require that

a. A majority of the members' primary area of interest is in a scientific area
b. At least one member holds a Ph.D. degree or equivalent
c. At least one member's primary area of interest is in a nonscientific area
d. A majority of the members are from or have ties to the institution of record

7. A purpose of monitoring clinical trials is to verify that:

a. The rights, safety, and well-being of human subjects are protected
b. Investigators receive adequate payment for their participation in the clinical trial
c. The investigator has received annual reports from the sponsor
d. The regulatory agency has received all case history information of subjects enrolled on the clinical trial

8. Which of the following is the proper way to make a correction to a CRF?

a. Completely blacken the incorrect entry and then enter the correct information
b. Back date the corrected entry with the date of the original entry
c. Initial using the initials of the sponsor’s representative who reviewed the change
d. Add the initials of the person making the change, the date of the change, and, if necessary, a brief explanation of the change