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  • 1.  RAC exam format

    Posted 02-Feb-2018 11:12
    ​Just looking for a sanity check from the group.

    I see that the RAC exam is 2 hour and 100 questions. It seems to me that when I took the exam (about 7 years ago) it was more questions and you were allotted more time to complete the exam.

    Can anyone confirm if the length of the exam has changed over the years?

    Thanks

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    Gregg Ritter RAC
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  • 2.  RE: RAC exam format

    Posted 02-Feb-2018 12:55
    Hi Greg,

    I Just took the exam last December. There were 100 multiple question and the time limit was 2 hrs.




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    Bhupinder Singh
    QA/RA Manager (RAC)
    San Jose CA
    United States
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    Original Message


  • 3.  RE: RAC exam format

    Posted 02-Feb-2018 14:21
    ​Hi Bhupinder/Gregg/RAPS Community,

    I am also preparing for my first RAC exam and I also have some questions for someone who has already taken the test.

    1. I know that the questions are multiple choice but I don't have any insight as to how the questions will be structured. In your experience, are the questions posed to you as in a situation and ask what you would do if...? or are they more straight from text as in... how many days do you have to wait before you can sell a product after you receive confirmation that the FDA has received a submission?
    2. Do any questions quiz you on definitions or dates? As in when was a particular legislation pass or what does along acronym stand for?
    3. There is a LOT of overall content in the book and toolbox offered by RAPS. From your experience, what should be the main thing to focus on in order to pass the test?
    Looking forward to hearing from you,



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    Elizabeth Zak
    Strongsville OH
    United States
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    Original Message


  • 4.  RE: RAC exam format

    Posted 04-Feb-2018 09:29
    Good questions, Elizabeth. I am wondering these as well. Also, do we need to have all the CFR part numbers memorized?

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    Kate Ashley
    Compliance and Regulatory Affairs Manager
    LifeScience Logistics
    DFW, TX
    United States
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    Original Message


  • 5.  RE: RAC exam format

    Posted 05-Feb-2018 08:48
    RAPS offers a sample exam you can purchase that mimics the format, content, and types of questions on the actual exam. It is well worth the small investment in order to become familiar with the exam. Hope this helps!

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    Susan Shockey RAC
    Manager Regulatory Affairs and Quality Management
    [Mt Pleasant SC
    United States
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    Original Message


  • 6.  RE: RAC exam format

    Posted 05-Feb-2018 08:57
    When I did the test there was a free practice exam on the RAPS website.  It is no longer free it appears.

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    Constance Brown RAC
    Manager, Regulatory Affairs CMC
    Johnson & Johnson Family of Companies - ENTERPRISE
    Ambler PA
    United States
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    Original Message


  • 7.  RE: RAC exam format

    Posted 05-Feb-2018 09:34

    ​Hi All,

    I will detail responses below, but first may I point you all in the direction of the RAC Candidate Guide: https://www.raps.org/RAPS/media/RAC-Credential/2018-RAC-Candidate-Guide.pdf

    The Candidate Guide provides information on all the questions listed above and if you are preparing to take the exam should be essential reading (I will admit it is not the most thrilling read, but if you are planning on taking the RAC it will come in very useful).  
    -------------------------------------------
    - Exam Format - 100 Questions, 120 minutes, multiple choice (4 options, a-d - one is correct, three are incorrect) 
    -------------------------------------------
    - There are three types of questions included on each examination:
    • Recall
    • Application
    • Analysis

    Recall questions ask for specific information, typically about regulations and guidance that are important aspects of the regulatory process. These questions may relate to any stage of product development and may relate to regulations specific for product types.

    Application questions require relating specific knowledge to a situation that may be encountered in the scope of practice of a regulatory professional.

    Analysis questions may be described as a small case or example requiring the candidate to read and assemble information in order to identify and evaluate various solutions.
    ----------------------------------------------
    I cannot say what specifically may be on the exam, but please see the Detailed Examination Content Outline in the appendices of the Candidate Guide which will give the domain and tasks that may come up in the exam along with an idea of the percentage of the exam that will be on that domain. 


    Please let me know if you have any other questions


    Regards,
      




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    Pete Etchells
    RAC Manager
    Rockville MD
    United States
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    Original Message


  • 8.  RE: RAC exam format

    Posted 05-Feb-2018 12:22
    Hi All,

    I also took the RAC US exam in the Fall session. 

    I agree with the post above - it is worth the investment to purchase a practice exam to see the types of questions you might expect. You may also find sample questions/flashcards/etc elsewhere on the internet, but the sample provided by RAPS will give you the best idea of format and question types. it also explains why particular answers are correct/incorrect, so it serves as a learning tool. Just be careful not to try and memorize those questions - I went through A LOT of practice questions when I was preparing and did not see any repeats on my exam. I found the real exam to be a bit more detail focused than the practice, but I don't know what other people thought.

    Good luck!

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    Andrew Hertsenberg, PhD, RAC
    Boston MA
    United States
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    Original Message


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