Test for SOCRA CCRP EXAM (Mega certification 2024) Q&A

Test for SOCRA CCRP EXAM (Mega certification 2024) Q&A 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