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.
The correct answers are bolded.
1. What is the minimum number of Institutional Review board (IRB) members?
2. The initial drug dose is 110mg/m2. Due to toxicity, the drug needs to be decreased by 30%. The new dosage would be?
3. The responsibility for ensuring that the investigator understands a clinical trial lies with:
a. The FDA
b. The IRB
c. The Sponsor
4. 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
5. 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