Preparing for the Exam

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

Once a candidate’s certification application has been approved, a complimentary electronic copy of the certification program reference manual will be sent. The purpose of the reference manual is to help you prepare for the Examination. It is a resource to assist you with your preparation; however, it is not an all-inclusive resource. See the Exam Overview and Exam Outline sections of the website for a detailed description of the concepts included in the examination. The preface to the reference manual is the Candidate Handbook.

The Certification Program Reference Manual includes:

• • • The Nuremberg Code
    • The Belmont Report
    • The Declaration of Helsinki
    • 21 U.S. Code of Federal Regulations – Parts 11, 50, 56, 312, 812
    • 45 U.S. Code of Federal Regulations – Part 46
    • ICH GCP Guideline for Good Clinical Practice E6(R3)
    • ICH Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (E2A)

Please note: The examination assesses your knowledge and understanding of the FDA regulations. You will not be tested on FDA guidance. However, some of these documents published by the FDA may be helpful in explaining concepts.

The final version of The ICH Harmonised Guideline, Guideline for Good Clinical Practice, E6(R3) was adopted on January 6, 2025. On January 27, 2025, the European Medicines Agency (EMA) announced an effective date of July 23, 2025 for E6 (R3).

The Current SOCRA Certification Examination content is based on the ICH Harmonised Guideline, Guideline for Good Clinical Practice, E6(R2). Beginning January 1, 2026 the exam content will reflect the ICH Harmonised Guideline, Guideline for Good Clinical Practice, E6(R3).

Applicants are encouraged to consider information provided in applicable journal articles, textbooks, manuals, workshops, or meetings specific to clinical trials and investigational drugs.

Disclaimer: The additional resources listed below may be helpful to you in your studies. However, please take note of the publication dates, as these references may contain outdated material. 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 and E2A Guidelines.

The following is a list of additional resources that you may wish to include in your study:

• • • Guide to Clinical Trials, Spilker, B., (Lippencott-Raven Publishers, 1991)
    • Investigator’s Handbook, Manual for Participation in Clinical Trials of Investigational Agents Sponsored by the Division of Cancer Treatments, National Cancer Institute (1986).
    • Investigator’s Handbook (Updated January 24, 2012)
    • Fundamentals of Clinical Trials, Feidman, L.; Furgerg, C.; DeMets, D., (Springer-Verlag Publishers, 1998)
    • Protecting Study Volunteers in Research, Cynthia McGuire Dunn, M.D, Gary Chadwich, PharmD
    • The CRC’s Guide to Coordinating Clinical Research. Karen E. Woodin, Ph.D.
    • Conducting Clinical Research, Judy Stone, MD.

The following is a list of websites that you may wish to include in your study:

• • • FDA Website: www.fda.gov
    • FDA’s Role: ClinicalTrials.gov Information
    • ICH Website: www.ich.org
    • Guidance for Industry – E6 Good Clinical Practice: Consolidated Guidance: View/print the “Guidance for Industry” (198 KB) (PDF)
    • OHRP Website: www.hhs.gov/ohrp/
    • Information Sheet Guidance for Institutional Review Boards (IRBs), Clinical Investigators, and Sponsors. Website: Click Here.

There have been new FDA Regulations enacted since the publication of these documents and the documents have not been updated to reflect the new regulations; however, they may be helpful in clarifying concepts)

• • • 21 CFR Part 314- Applications for FDA Approval to Market a New Drug
    • 21 CFR Part 814- Premarket Approval of Medical Devices

CITI website

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