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
...
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
[Show More]
