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CCRP SOCRA Exam test preparation Questions and Must have marking scheme Updated version 2024/2025 CA$17.39   Add to cart
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CCRP SOCRA Exam test preparation Questions and Must have marking scheme Updated version 2024/2025
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CCRP SOCRA Exam test preparation Questions and Must have marking scheme Updated version 2024/2025 This form is used for the voluntary reporting of adverse events and product problems: A) 1571 B) 1572 C) 3500 D) 3500A - correct answer C) 3500 Reminder: 3500 is for voluntary; 3500A is for...

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Document information

  • November 5, 2024
  • 20
  • 2024/2025
  • Exam (elaborations)
  • Questions & answers

Subjects

  • irb
  • 21cfr50 subpart b
  • 45 cfr 46 and 21 cfr 5055
  • fda regulation
  • waiver of irb requirement
  • the investigator and the coordinator
  • ccrp socra exam test preparation questions and mus

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  • CCRP SOCRA
  • CCRP SOCRA

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KieranKent55

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CCRP SOCRA Exam test preparation
Questions and Must have marking scheme
Updated version 2024/2025

This form is used for the voluntary reporting of adverse events
and product problems:


A) 1571
B) 1572
C) 3500
D) 3500A - correct answer C) 3500


Reminder: 3500 is for voluntary; 3500A is for mandatory


Each IRB that reviews studies involving children as subjects is
covered by:


A) 21CFR Part 56, Sub part A
B) 21CFR Part 56, Sub part B
C) 21CFR Part 50, Sub part C
D) 21CFR Part 56, Sub part D - correct answer D) 21CFR Part
56, Sub part D


This form is used for the mandatory reporting of serious adverse
events:


A) 1571

,B) 1572
C) 3500
D) 3500A - correct answer D) 3500A


What is covered in 21CFR50 Subpart B?


A) Informed consent of Human Subjects
B) IRB Functions and Operations
C) Records and Reports
D) Additional Safeguards for Children in Clinical Investigations -
correct answer A) Informed consent of Human Subjects


True or False:


The IRB must determine that requirements for permission by
parents or guardians and assent by children are met. - correct
answer True


Explanation: According to 45 CFR 46 and 21 CFR 50.55


What topic is covered in 45 CFR 46 Subpart B?


A) Additional Safeguards and Protections
B) Additional Protection for Prisoners and Vulnerable Subjects
C) Additional Protection for Children and Unborn Fetuses
D) None of the above - correct answer D) None of the above

, The clinical investigator will update the financial disclosure
information if any relevant changes occur during
the investigation's course and for _______ following the study's
completion.


A) 6 months
B) 1 year
C) 2 years
D) 5 years - correct answer B) 1 Year


The 3 fundamental ethical principles for human subjects' in
research are:


A) Respect for persons, beneficence, justice
B) Respect for subjects, their safety and their time
C) Respect for sponsor, IRB and FDA guidelines
D) Respect for data, welfare and discovery - correct answer A)
Respect for persons, beneficence, justice


Each IRB that uses an expedited review procedure must adopt a
method for keeping all members advised of research proposals
which have been approved under the expedited review procedure
_________.


A) 45 CFR 46.110; CFR 56.110(c)
B) 45 CFR 46.110(c); 21 CFR 56.110

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