What is 21 cfr 50 - Study guides, Class notes & Summaries
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CCRP Definitions Exam Questions With 100% Correct Answers.
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21 CFR 50 - Protection of Human Subjects 
Sponsor - a person who initiates a clinical investigation, but who does not actually conduct the 
investigation 
Sponsor-investigator - an individual who both initiates and actually conducts (alone or with 
others) a clinical investigation 
Human subject - an individual who is or becomes a participant in research, either as a recipient of 
the test article or as a control 
Institution - any public or private entity or agency 
Institutional Review Board (...
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CCRP exam with 100% correct answers 2024 latest update already graded A+
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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 
 
 
 
 
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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 relat...
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SOCRA Practice Test with 100% Correct Solutions
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SOCRA Practice Test with 100% Correct Solutions 
Which of the following is a disclosure of financial interests form? -Answer-FDA Form 
3455 
Which of the following is a certification of financial interest form? -Answer-FDA Form 
3454 
If the investigator did have financial arrangement with the sponsor, he/she would submit 
the following form: -Answer-FDA Form 3455 
This form is submitted by sponsor to the FDA prior to the beginning of the drug trial - 
Answer-Investigational New Drug Application...
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Exam(Elaborations)ACRP-CP 2023 Correctly Answered
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Exam(Elaborations)ACRP-CP 2023 
Correctly Answered 
Belmont Report (1979) - Answer ️️ -ethical principles and guidelines for the protection of 
human subjects of research. 
respect for persons - Answer ️️ -individuals should be treated as autonomous agents and 
persons with diminished autonomy are entitled to protection 
An autonomous person - Answer ️️ -A person capable of deliberation about personal goals and 
of acting under the direction of such deliberation 
Beneficence - Answer...
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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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CCRP Definitions with complete solutions | Latest 2023/2024
- Exam (elaborations) • 26 pages • 2023
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Exam(Elaborations)ACRP-CP 2023 Correctly Answered
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Exam(Elaborations)ACRP-CP 2023 
Correctly Answered 
Belmont Report (1979) - Answer ️️ -ethical principles and guidelines for the protection of 
human subjects of research. 
respect for persons - Answer ️️ -individuals should be treated as autonomous agents and 
persons with diminished autonomy are entitled to protection 
An autonomous person - Answer ️️ -A person capable of deliberation about personal goals and 
of acting under the direction of such deliberation 
Beneficence - Answer...
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ACRP-CP Exam Questions With Latest Solutions 2024
- Exam (elaborations) • 92 pages • 2024
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ACRP-CP Exam Questions With Latest 
Solutions 2024 
Belmont Report (1979) - answerethical principles and guidelines for the protection of 
human subjects of research. 
respect for persons - answerindividuals should be treated as autonomous agents and 
persons with diminished autonomy are entitled to protection 
An autonomous person - answerA person capable of deliberation about personal goals and 
of acting under the direction of such deliberation 
Beneficence - answerDo not harm and maximize po...
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SOCRA Practice Test Questions with Verified Answers Top-Rated 2024
- Exam (elaborations) • 9 pages • 2024
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Which of the following is a disclosure of financial interests form? - FDA Form 3455 
 
Which of the following is a certification of financial interest form? - FDA Form 3454 
 
If the investigator did have financial arrangement with the sponsor, he/she would submit the following form: - FDA Form 3455 
 
This form is submitted by sponsor to the FDA prior to the beginning of the drug trial - Investigational New Drug Application (1571) 
 
In the top right corner, form have OMB number. What does it s...
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ACRP-CP Exam Questions With Latest Solutions 2024
- Exam (elaborations) • 92 pages • 2024
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ACRP-CP Exam Questions With Latest 
Solutions 2024 
Belmont Report (1979) - answerethical principles and guidelines for the protection of 
human subjects of research. 
respect for persons - answerindividuals should be treated as autonomous agents and 
persons with diminished autonomy are entitled to protection 
An autonomous person - answerA person capable of deliberation about personal goals and 
of acting under the direction of such deliberation 
Beneficence - answerDo not harm and maximize po...
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