CCRP Exam Questions Bank | 273 Questions with 100% CORRECT ANSWERs
Question :5
CORRECT ANSWER :The minimum number of IRB
members
Question :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?
CORRECT ANSWER :Subjects cannot be enrolled until
IRB/IEC approval has been obtained
Question :The responsibility for ensuring that the investigator
understands a clinical trial lies with:
CORRECT ANSWER :The Sponsor
Question :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
Question :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.
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.
Question :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
Question :A purpose of monitoring clinical trials is to verify
that:
CORRECT ANSWER :The rights, safety, and well-being of
human subjects are protected
Question :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.
Question :What details need to be documented in the subject
source documentation when an Adverse Event (AE) occurs?
Select all that apply A. The severity of the event B. When the event occurred C. Setting in which the event occurred
CORRECT ANSWER :A. The severity of the event B. When
the event occurred C. Setting in which the event occurred
Question :What is an Unexpected Adverse drug reaction?
CORRECT ANSWER :A reaction that is not consistent with
the applicable product information
Question :The terms "serious" and "severe" are synonymous
according to ICH.
CORRECT ANSWER :FALSE
Question :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 A. Results in death B. Is life-threatening C. Is a congenital anomaly
CORRECT ANSWER :A. Results in death B. Is life-
threatening C. Is a congenital anomaly