45 cfr 46 and 21 cfr 5055 - Study guides, Class notes & Summaries
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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 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, ...
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