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:
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 Reference Manual is also available for purchase here.
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 However, please take note of the publication dates, as these references may contain outdated material.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:
The following is a list of websites that you may wish to include in your study:
(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)
CITI website: www.citiprogram.org
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