What is ich e6 8 - Study guides, Class notes & Summaries
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SOCRA Practice 1 questions and answers latest 2023
- Exam (elaborations) • 205 pages • 2023
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SOCRA Practice 1 questions and answers latest 2023 
True or False 
The terms "treatment protocol" and "treatment IND" are interchangeable and mean the same thing. 
False. A treatment protocol is sponsored by a sponsor, while a treatment IND (Investigational New Drug) is sponsored by a licensed medical practitioner who becomes a sponsored investigator. 
21 CRF 312.35 
 
 
 
True or False 
Investigators are responsible for periodically requesting updates regarding new information gleaned by a ...
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CCRA EXAM LATEST QUESTIONS AND ANSWERS
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CCRA EXAM LATEST QUESTIONS AND ANSWERS 
 
What is 21 CFR 812? 
IDE 
What is 21 CFR 600? 
Biological Products 
What is 21 CFR 11? 
Electronic Records 
What is 21 CFR 50? 
Informed Consent 
What is ICH E6: 8 
Essential Documents 
What is the purpose of maintaining study document and records? 
Insure compliance; dealing with safety of patient, things have to be written down 
What are source document? 
First place data is written 
What are case report forms? 
Provides format for collecting protocol-...
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CCRA Exam With Correct Questions And Answers 2024
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CCRA Exam With Correct Questions And Answers 2024
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ACRP-CP Questions & Answers(VERIFIED)
- Exam (elaborations) • 83 pages • 2023
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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 Do not harm and maximize possible benefits and minimize possible harms 
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