45 cfr part 46 subpart e - Study guides, Class notes & Summaries
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CCRP SoCRA Exam Latest Update Rated A
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CCRP SoCRA Exam Latest Update Rated A 
21 CFR Part 11 Electronic Records; Electronic Signatures 
21 CFR Part 11 Subpart B Electronic Records 
21 CFR Part 11 Subpart C Electronic Signatures 
21 CFR Part 50 Protection of Human Subjects 
21 CFR Part 50 Subpart B Informed Consent of Human Subjects 
21 CFR Part 50 Subpart D Additional Safeguards for Children in Clinical Investigations 
21 CFR Part 56 Institutional Review Board 
21 CFR Part 56 Subpart B Organization and Personnel 
21 CFR Part 56 Subpa...
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CCRP SOCRA Exam - Practice Exam #1 Questions and Answers 2023
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CCRP SOCRA Exam - Practice Exam #1 Questions and Answers 2023 
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, s...
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CCRP SOCRA FINAL EXAM STUDY GUIDE.
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CCRP SOCRA FINAL EXAM STUDY GUIDE. 
21 CFR Part 11 - correct answer Electronic Records; Electronic Signatures 
 
21 CFR Part 11 Subpart B - correct answer Electronic Records 
 
21 CFR Part 11 Subpart C - correct answer Electronic Signatures 
 
21 CFR Part 50 - correct answer Protection of Human Subjects 
 
21 CFR Part 50 Subpart B - correct answer Informed Consent of Human Subjects 
 
21 CFR Part 50 Subpart D - correct answer Additional Safeguards for Children in Clinical Investigations 
 
21 CF...
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CCRP SoCRA Exam guide Questions and Answers
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21 CFR Part 11 
Electronic Records; Electronic Signatures 
21 CFR Part 11 Subpart B 
Electronic Records 
21 CFR Part 11 Subpart C 
Electronic Signatures 
21 CFR Part 50 
Protection of Human Subjects 
21 CFR Part 50 Subpart B 
Informed Consent of Human Subjects 
21 CFR Part 50 Subpart D 
Additional Safeguards for Children in Clinical Investigations 
21 CFR Part 56 
Institutional Review Board 
21 CFR Part 56 Subpart B 
Organization and Personnel 
21 CFR Part 56 Subpart C 
IRB Functions and Operati...
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CCRP SoCRA Exam Questions with 100% Correct Solutions Graded to PASS
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21 CFR Part 11 
Electronic Records; Electronic Signatures 
 
 
21 CFR Part 11 Subpart B 
Electronic Records 
 
 
21 CFR Part 11 Subpart C 
Electronic Signatures 
 
 
21 CFR Part 50 
Protection of Human Subjects 
 
 
21 CFR Part 50 Subpart B 
Informed Consent of Human Subjects 
 
 
21 CFR Part 50 Subpart D 
Additional Safeguards for Children in Clinical Investigations 
 
 
21 CFR Part 56 
Institutional Review Board 
 
 
21 CFR Part 56 Subpart B 
Organization and Personnel 
 
 
21 CFR Part 56 Subp...
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SOCRA - CCRP (high level) Questions and Answers (100% Correct Solutions)
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Nuremberg Code (1947) 
A research ethics code that arose in response to the Nazis' inhumane experimentation (nuremberg trials) - holocaust, racial hygiene / eugenics / master race. 
 
 
The Nuremberg Code - 10 points 
1. voluntary 
2. necessary for results 
3. logical design and results 
4. avoid unnecessary harm 
5. cannot result in death or disablement 
6. risk assessment 
7. protect subjects against harm 
8. qualified investigators 
9. right to withdrawal 
10. right to end trial if needed 
 ...
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General CIP Questions with Complete Solutions 100% Verified Answers 2023
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The belmont report was formulated by? - Correct Answer The National Commission for the protection of human subjects in biomedical and behavioral research 
 
The revised common rule revised - Correct Answer 45 CFR 46 Subpart A 
 
HHS certification Institution Responsibilities - Correct Answer The Institution bears full responsibility for all research involving human subjects covered under its Assurance. For all HHS-conducted or supported research, all of the requirements of the HHS Regulations at...
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HCCA - CHPC Study Questions (MASTER FLASHCARDS) Graded A 2024
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What is the purpose of HIPAA? – 
• Protect PHI from unauthorized disclosure/use; 
• Prevent fraud, waste and abuse (via Administrative Simplification); 
• Make health insurance portable under ERISA; 
• Move health care onto a nationally standardized electronic billing platform 
HIPAA resides in which CFR section? - 45 CFR sections 164.102 through 164.534 

What are the subparts of HIPAA part 164? - HIPAA - 45 CFR 164, subparts: Subpart A - General rules Subpart C - Security Subpart D -...
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CITI Social and Behavioral Researchers Quiz with 100%Verified Answers.
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CITI Social and Behavioral Researchers Quiz with 100%Verified Answers. 
Belmont Report correct answers provides the ethical framework for the federal regulations 
designed to protect human research subjects. 
Belmont Report and Its Principles correct answers 
The Belmont Report's principle of respect for persons incorporates at least two ethical 
convictions: first, that individuals should be treated as autonomous agents, and second, that: 
correct answers Persons with diminished autonomy are e...
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CCRP SoCRA Exam Cert Exam Questions with Verified Answers 2024
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CCRP SoCRA Exam Cert Exam 
Questions with Verified Answers 2024 
21 CFR Part 11 - CORRECT ANSWER-Electronic Records; Electronic Signatures 
21 CFR Part 11 Subpart B - CORRECT ANSWER-Electronic Records 
21 CFR Part 11 Subpart C - CORRECT ANSWER-Electronic Signatures 
21 CFR Part 50 - CORRECT ANSWER-Protection of Human Subjects 
21 CFR Part 50 Subpart B - CORRECT ANSWER-Informed Consent of Human 
Subjects 
21 CFR Part 50 Subpart D - CORRECT ANSWER-Additional Safeguards for Children in 
Clinical ...
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