MEGA SOCRA CCRP EXAM CONTENT REVIEW PRACTICE TEST.

MEGA SOCRA CCRP EXAM CONTENT REVIEW PRACTICE TEST. 5 - correct answer The minimum number of IRB members Subjects cannot be enrolled until IRB/IEC approval has been obtained - correct answer In a non-emergency situation, under which of the following conditions, if any, may subjects be enrolled into a study prior to IRB/IEC approval? The Sponsor - correct answer The responsibility for ensuring that the investigator understands a clinical trial lies with: A subject has been enrolled on a study and was randomized to the non-treatment arm. The protocol outlines study procedures for all subjects to be performed within one week of enrollment. Which of the following statements about this case is correct? - correct answer This subject should undergo all study procedures as outlined in the protocol A significant risk device is defined as an investigational device that is: - correct answer 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. With respect to IRB/IEC membership, both the FDA and the ICH require that - correct answer At least one member's primary area of interest is in a nonscientific area The rights, safety, and well-being of human subjects are protected - correct answer A purpose of monitoring clinical trials is to verify that: Which of the following is the proper way to make a correction to a CRF? - correct answer Add the initials of the person making the change, the date of the change, and, if necessary, a brief explanation of the change. What details need to be documented in the subject source documentation when an Adverse Event (AE) occurs? Select all that apply - correct answer A. The severity of the event B. When the event occurred C. Setting in which the event occurred What is an Unexpected Adverse drug reaction? - correct answer A reaction that is not consistent with the applicable product information The terms "serious" and "severe" are synonymous according to ICH. - correct answer FALSE A serious adverse event is any untoward medical occurrence which at any dose is best described by which of the following statements? Select all that apply - correct answer A. Results in death B. Is life-threatening C. Is a congenital anomaly . Which of the following options describes the term "severe" in regards to ICH? - correct answer The Intensity of a specific event Subject 3826 had to stay in the hospital for three extra days when his legs started swelling after participation in a cardiac drug study. Swelling of the legs was listed in the Investigator's Brochure as a possible side effect. Which of the following options best describes this situation? - correct answer Serious Adverse Drug Reaction A subject in your diabetes research study developed colon cancer, which the Investigator has determined to be unrelated to the study. The subject is currently asymptomatic. This will be considered a serious adverse event because it is life threatening. Is this a true or false statement? - correct answer FALSE In pre-market approval studies, all noxious and unintended responses to a medicinal product, even possibly related to any dose, should be considered which of the following options? - correct answer Adverse Drug Reaction A subject has a suspected serious adverse drug reaction with the outcome of death. Per the ICH E2A guideline, which are items that should be submitted to the Sponsor? - correct answer 1. A de-identified autopsy report, if available 2. Cause of death, and a comment on its possible relationship to the suspected drug reaction Two weeks after starting an investigational therapy, a subject is rushed to the hospital after experiencing a heart attack. The subject is currently being treated in the Intensive Care Unit (ICU). The ICU doctor has noticed that the subject was enrolled in the trial and has contacted the trial Principal Investigator. Heart attack is not described in the Investigator's Brochure. What actions must be taken by the Principal Investigator? - correct answer 1. Report to the Sponsor per the protocol timelines for serious, unexpected events. 2. Report to the IRB/IEC per their event reporting requirements for serious, unexpected events. What is the timeframe for "expedited" reporting of serious, fatal or life-threatening, unexpected adverse drug reactions to regulatory authorities? - correct answer As soon as possible, but no later than seven calendar days after first knowledge of the event Adverse Drug Reaction (ADR) Example - correct answer Your third subject in a Phase III drug trial calls to report that she has developed a rash on her chest 12 hours after taking her second dose of the investigational study drug. She states that it itches and is slightly uncomfortable. She tells you that she has never had a rash and this is totally unexpected. You know from the Investigator Drug Brochure that only 12% of the patients get a rash from this drug. Which of the following options best describes this situation? What is the purpose of the IRB/IEC? - correct answer Safeguard the rights, safety, and well-being of all trial subjects Who is responsible for designing the clinical trial protocol? - correct answer Sponsor Informed Consent Process - correct answer The process by which a subject voluntarily confirms his or her willingness to participate in a clinical trial is best described as which of the following options? The Monitor - correct answer Who is ultimately responsible for Source Data Verification or SDV? A. At least five members B. At least one member whose primary interest is non-scientific C. At least one member who is independent from the Institution/trial site - correct answer The IRB/IEC should consist of a reasonable number of members, who collectively have the qualifications and experience to review and evaluate the science, medical aspects, and ethics of the proposed trial. It is recommended that the IRB/IEC should include which of the following options? Which of the following is NOT one of the required elements of an informed consent form? - correct answer A listing of all site personnel who will be involved in the research Name 3 of several required elements of an informed consent form - correct answer 1. The purpose of the research 2. A description of benefits that may be reasonably expected from the research 3. A contact person for questions about the research According to ICH E6, who must sign the Informed Consent Form or ICF? - correct answer The person who conducted the informed consent discussion The subject or the subject's legally acceptable representative As per ICH E6 GCP, which groups of potential subjects could be defined as "vulnerable subjects"? - correct answer Members of the armed forces Patients with incurable diseases Persons in nursing homes As per ICH E6 GCP, patients with heart conditions alone are defined as "vulnerable subjects"? - correct answer False