Ccrp exam Study guides, Class notes & Summaries
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CCRP Exam Questions Bank | 273 Questions with 100% Correct Answers
- Exam (elaborations) • 31 pages • 2022
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How many days does a sponsor have to report an emergency use of an IP to the FDA? 
- 5 working days 
How many members must sit on an IRB? - 5 
How long must an IRB retain records per 21 CFR 56? - 3 years after completion of 
research 
What are the criteria for IRB approval of research? (7) - 1. Risks to subjects are 
minimized 
2. Risks are reasonable in relation to anticipated benefits 
3. Selection of subjects is equitable 
4. Informed consent will be sought from subjects or LARs 
5. Informed ...
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CCRP SOCRA Exam - Practice Exam with 100% Correct Answers | Latest 2023/2024
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CCRP SOCRA Exam - Practice Exam with 100% Correct Answers | Latest 2023/2024 
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 
heal...
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BUNDLE - CCRP EXAMS
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BUNDLE - CCRP EXAMS
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MEGA SOCRA CCRP EXAM CONTENT| 790 QUESTIONS (100 PAGES)| WITH COMPLETE SOLUTION
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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. T...
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CCRP EXAM 2024 WITH 100% CORRECT ANSWERS
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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 answer 5 working days 
 
How many members must sit on an IRB? - correct answer 5 
 
How long must an IRB retain records per 21 CFR 56? - correct answer 3 years after completion of research 
 
What are the criteria for IRB approval of research? (7) - correct answer 1. Risks to subjects are minimized 
2. Risks are reasonable in relation to anticipated benefits 
3...
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SOCRA CCRP EXAM 2024 WITH 100% CORRECT ANSWERS
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SOCRA CCRP EXAM 2024 WITH 100% CORRECT ANSWERS 
 
 
April 30 1996 - correct answer ICH GCP Development Date 
 
Quality - correct answer ICH Q 
 
Efficacy - correct answer ICH E 
 
Safety - correct answer ICH S 
 
Multidisciplinary - correct answer ICH M 
 
guidance for industry, consolidated guideance - correct answer ICH E 6 
 
Clinical Safety Data Management Definitions and Standards - correct answer ICH E2A 
 
Safety pha
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CCRP EXAM 2024 WITH 100% CORRECT ANSWERS
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CCRP EXAM 2024 WITH 100% CORRECT ANSWERS 
 
Who was tried in the Nuremburg Military Tribunals and why? - correct answer Doctors who committed war crimes against humanity including medical experiments on concentration camp inmates and other human subjects without consent 
 
What was the outcome of the Nuremburg Military Tribunals? - correct answer After 140 days of proceedings with testimony of 85 witnesses and submission of 1,500 documents, American judges convicted 16 doctors on 8/20/1947. Seve...
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CCRP AACVPR Pulmonary Rehab Exam 1 | 151 Questions and Answers 100% correct
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CCRP AACVPR Pulmonary Rehab Exam 1 | 151 Questions and Answers 100% correct
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CCRP Exam 2024 with 100%Correct Answers.
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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 Questions Bank | 273 Questions with 100% Correct Answers
- Exam (elaborations) • 30 pages • 2022
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How many days does a sponsor have to report an emergency use of an IP to the FDA? - 5 working days How many members must sit on an IRB? - 5 How long must an IRB retain records per 21 CF R 56? - 3 years after completion of research What are the criteria for IRB approval of research? (7) - 1. Risks to subjects are minimized 2. Risks are reasonable in relation to anticipated benefits 3. Selection of subjects is equitable 4. Informed consent will be sought from subjects or LARs 5. Informed consent w...
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