Ccrp written exam Study guides, Class notes & Summaries
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CCRP SOCRA Exam - Practice Exam 1
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CCRP SOCRA Exam - Practice Exam 1 
 
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) P...
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CCRP SOCRA Exam - Practice Exam Correctly Answered.
- Exam (elaborations) • 15 pages • 2024
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CCRP SOCRA Exam - Practice Exam Correctly Answered. 
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 - correct answer C) Sponsor 
 
What is the minimum number of IRB Members? 
 
A) 3 
B) 5 
C) 6 
D) 10 - correct answer 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...
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CCRP Exam 2024 with 100%Correct Answers.
- Exam (elaborations) • 42 pages • 2024
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CCRP Exam 2024 with 100%Correct Answers. 
How many days does a sponsor have to report an emergency use of an IP to the FDA? correct answer5 
working days 
How many members must sit on an IRB? correct answer5 
How long must an IRB retain records per 21 CFR 56? correct answer3 years after completion of research 
What are the criteria for IRB approval of research? (7) correct answer1. Risks to subjects are minimized 
2. Risks are reasonable in relation to anticipated benefits 
3. Selection of subje...
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CCRP Exam 2024 with 100%Correct Answers.
- Exam (elaborations) • 42 pages • 2024
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CCRP Exam 2024 with 100%Correct Answers. 
How many days does a sponsor have to report an emergency use of an IP to the FDA? correct answer5 
working days 
How many members must sit on an IRB? correct answer5 
How long must an IRB retain records per 21 CFR 56? correct answer3 years after completion of research 
What are the criteria for IRB approval of research? (7) correct answer1. Risks to subjects are minimized 
2. Risks are reasonable in relation to anticipated benefits 
3. Selection of subj...
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CCRP Exam Questions with Complete Solutions A Grade
- Exam (elaborations) • 15 pages • 2023
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CCRP Exam Questions with Complete Solutions A Grade 
 
Year/ description of the Nuremberg Code - Answer-1947- German physicians conducted unethical experiments on concentration camp prisoners without their consent. 
 
What implications came of the Nuremberg Code? - Answer-Ten elements of human research including voluntary informed consent is absolutely essential. 
 
Year and description of the Declaration of Helsinki - Answer-1964- Based on the principles of the Nuremberg code. This declaration...
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SOCRA CCRP Exam 2022 Review with Comprehensive Solutions | Latest 2023/2024
- Exam (elaborations) • 10 pages • 2023
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SOCRA CCRP Exam 2022 Review with Comprehensive Solutions | Latest 2023/2024 
SAE ️ Serious Adverse Event: 
- results in death 
- is life threatening (patient was at risk of death at time of the event) 
- results in persistent or significant disability 
- congenital anomaly/birth defect 
Short Form ️ A document that states that the elements of informed 
consent have been presented orally to and understood by the participant 
or the participant's LAR. 
4 components of short form ️ 1. A shor...
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CCRP SOCRA Exam | 100% Correct Answers | Verified | Latest 2024 Version
- Exam (elaborations) • 19 pages • 2024
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CCRP SOCRA Exam | 100% Correct 
Answers | Verified | Latest 2024 Version 
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 healt...
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CCRP SOCRA Practice Exam 2024 Final questions and correct answers
- Exam (elaborations) • 11 pages • 2024
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CCRP SOCRA Practice Exam 2024 Final 
questions and 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 - CORRECT ANSWER-C) Sponsor 
What is the minimum number of IRB Members? 
A) 3 
B) 5 
C) 6 
D) 10 - CORRECT ANSWER-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...
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CCRP SOCRA Exam - Practice Exam #1: Exam Review Questions and answ/ LATEST EXAM PREDICTIONS UPDATES, APPROVED. ers, VERIFIED/
- Exam (elaborations) • 12 pages • 2024
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CCRP SOCRA Exam - Practice Exam #1: 
Exam Review Questions and answers, 
VERIFIED/ 
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 
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A significant risk device is...
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BTM 1 225 Practice Test Quizzes Online, Trivia, Questions & Answers - ProProfs Quizzes.
- Exam (elaborations) • 15 pages • 2024
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BTM 1 225 Practice Test Quizzes Online, Trivia, Questions & Answers - ProProfs Quizzes. 
 
 
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