2023 ccrp socra test Study guides, Class notes & Summaries
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SOCRA CCRP 2023 EXAM WITH OVER 230 ACTUAL QUESTIONS AND VERIFIED ANSWERS GRADED A+ (2024 UPDATE)
- Exam (elaborations) • 30 pages • 2024
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SOCRA CCRP 2023 EXAM WITH OVER 230 ACTUAL QUESTIONS AND VERIFIED ANSWERS GRADED A+ (2024 UPDATE)
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CCRP SOCRA EXAM 2023 QUESTIONS AND ANSWERS
- Exam (elaborations) • 12 pages • 2024
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CCRP SOCRA EXAM 2023 QUESTIONS AND ANSWERS
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SOCRA CCRP Exam 2023 questions and answers
- Exam (elaborations) • 17 pages • 2023
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SOCRA CCRP Exam 2023 questions and answers 
April 30 1996 
ICH GCP Development Date 
 
 
 
Quality 
ICH Q 
 
 
 
 
 
 
00:55 
 
01:41 
Efficacy 
ICH E 
 
 
 
Safety 
ICH S 
 
 
 
Multidisciplinary 
ICH M 
 
 
 
guidance for industry, consolidated guideance 
ICH E 6 
 
 
 
Clinical Safety Data Management Definitions and Standards 
ICH E2A 
 
 
 
Safety pharmacology studies for human pharmaceuticals 
ICH S7A 
 
 
 
Electronic records, electronic signatures 
21 CFR Part 11 
 
 
 
Informed Consent 
...
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SOCRA - CCRP (high level)Study Guide Test Reviewed Questions and Answers 2023.
- Exam (elaborations) • 49 pages • 2023
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SOCRA - CCRP (high level)Study Guide Test Reviewed Questions and Answers 2023. 
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. qu...
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SOCRA CCRP Certification Test 6 Updated Questions and Answers 2023
- Exam (elaborations) • 54 pages • 2023
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SOCRA CCRP Certification Test 6 Updated Questions and Answers 2023 
CFR Title 21: Part 11 
Electronic Records; Electronic Signatures 
 
 
 
Part 11, Subpart A: General Provisions 
-must be trustworthy, reliable, and generally equivalent to paper records 
-applies to electronic forms that are created, modified, maintained, archived, retrieved, or transmitted 
-where records meet requirements, it will be considered equivalent to full handwritten signatures, initials, etc. 
-must be available and s...
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