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Sample CHRC exam questions

1. Who may the FDA sanction in response to a failure to report adverse events to the IRB and study 
    sponsor?
 
        a. Research coordinator 
        b. Clinical department 
        c. Other research sites 
        d. Principal investigator


The sample questions are only intended to help familiarize you with the format of the exam. Questions presented here are not indicative of the actual exam, and results should not be inferred of actual exam results.

2. According to HHS, an IRB may use an expedited review process 
    for a study in an expedited category when which of the following 
    is present?
 
        a. The research involves no more than a minimal risk 
        b. Changes in previously approved research were less than 
            three years ago 
        c. Informed consent from the subject will be obtained 
        d. The research findings will only be published locally

3. All employees should receive compliance-related training on: 
        a. Patient confidentiality 
        b. Stark self-referral laws 
        c. Intermediate sanctions 
        d. Biosafety

4. In a risk assessment process, after identifying an initial list of risk areas, which of the following 
    steps should a compliance professional take NEXT?
 
        a. Prioritize risk areas into high, medium, or low categories 
        b. Discuss risk areas selected for review with legal counsel 
        c. Discuss risk areas selected for review with legal counsel 
        d. Interview senior management throughout the organization

5. An uninsured patient requests a reduced rate for knee replacement surgery. The doctor believes 
    that the surgery is essential and will help prolong the patient’s life through improved exercise 
    opportunities. The hospital is currently conducting a clinical trial on knee surgery, but the 
    patient does not qualify. If the doctor arranges a discounted research rate for the patient, 
    the institution could be subject to potential liability for violation of:
 
        a. False Claims Act 
        b. Common Rule 
        c. Anti-Kickback Statute 
        d. CLIA


Answer key: 1. D, 2. A, 3. A, 4. A, 5. C