CCRP SOCRA Exam - Practice Exam with 100% Correct Answers. The responsibility for ensuring that the investigator understands a clinical trial lies with which individual/or organization? A) FDA B) IRB C) Sponsor D) Coordinator ✔️ C) Sponsor What is the minimum number of IRB Members? A) 3 B) 5 C) 6 D) 10 ✔️ B) 5 A significant risk device is defined as an investigational device that is: 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. D) All the above ✔️ D ) All of the above With respect to IRB/IEC membership, both the FDA and the ICH require that: A) A majority of the members' primary area of interest is in a scientific area B) At least one member holds a Ph.D. degree or equivalent C) At least one mem ber's primary area of interest is in a nonscientific area D) A majority of the members are from or have ties to the institution of record ✔️ C) At least one member's primary area of interest is in a nonscientific area In a non -emergency situation, under which of the following conditions, if any, may subjects been rolled into a study prior to IRB/IEC approval? A) The investigator provides his/her written approval B) The study drug has an FDA approved marketing application C) The FDA provides written app roval of the IND D) Subjects cannot be enrolled until IRB/IEC approval has been obtained ✔️ D) Subjects cannot be enrolled until IRB/IEC approval has been obtained A subject has been enrolled on a study and was randomized to the non -
treatment arm. The p rotocol outlines study procedures for all subjects to be performed within one week of enrollment. Which of the following statements about this case is correct? A) This subject does not need to undergo any of the study procedures since the subject is enrol led on the non -treatment arm B) This subject should undergo all study procedures as outlined in the protocol C) This subject only needs to undergo the study procedures that pertain specifically to the subject D) This subject can undergo the study procedures whenever it is convenient ✔️ B) This subject should undergo all study procedures as outlined in the protocol A purpose of monitoring clinical trials is to verify that: A) The rights, safety, and well -being of human subjects are protected
treatment arm. The p rotocol outlines study procedures for all subjects to be performed within one week of enrollment. Which of the following statements about this case is correct? A) This subject does not need to undergo any of the study procedures since the subject is enrol led on the non -treatment arm B) This subject should undergo all study procedures as outlined in the protocol C) This subject only needs to undergo the study procedures that pertain specifically to the subject D) This subject can undergo the study procedures whenever it is convenient ✔️ B) This subject should undergo all study procedures as outlined in the protocol A purpose of monitoring clinical trials is to verify that: A) The rights, safety, and well -being of human subjects are protected
