510k clearance - Study guides, Class notes & Summaries
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SOCRA CCRP Exam- Questions and Answers
- Exam (elaborations) • 17 pages • 2022
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April 30 1996 - ANSWER-ICH GCP Development Date 
 
Quality - ANSWER-ICH Q 
 
Efficacy - ANSWER-ICH E 
 
Safety - ANSWER-ICH S 
 
Multidisciplinary - ANSWER-ICH M 
 
guidance for industry, consolidated guideance - ANSWER-ICH E 6 
 
Clinical Safety Data Management Definitions and Standards - ANSWER-ICH E2A 
 
Safety pharmacology studies for human pharmaceuticals - ANSWER-ICH S7A 
 
Electronic records, electronic signatures - ANSWER-21 CFR Part 11 
 
Informed Consent - ANSWER-21 CFR Part 50 
 
Fina...
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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 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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CCRP SOCRA Exam Graded A+
- Exam (elaborations) • 17 pages • 2022
- Available in package deal
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April 30 1996 - ANSWER ICH GCP Development Date 
 
Quality - ANSWER ICH Q 
 
Efficacy - ANSWER ICH E 
 
Safety - ANSWER ICH S 
 
Multidisciplinary - ANSWER ICH M 
 
guidance for industry, consolidated guideance - ANSWER ICH E 6 
 
Clinical Safety Data Management Definitions and Standards - ANSWER ICH E2A 
 
Safety pharmacology studies for human pharmaceuticals - ANSWER ICH S7A 
 
Electronic records, electronic signatures - ANSWER 21 CFR Part 11 
 
Informed Consent - ANSWER 21 CFR Part 50 
 
Fina...
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