21 cfr 11 Study guides, Class notes & Summaries
Looking for the best study guides, study notes and summaries about 21 cfr 11? On this page you'll find 432 study documents about 21 cfr 11.
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SOCRA CCRP Exam Questions Perfectly Answers
- Exam (elaborations) • 24 pages • 2024
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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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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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SOCRA - CCRP (high level) Questions and Answers (100% Correct Solutions)
- Exam (elaborations) • 68 pages • 2023
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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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SOCRA EXAM 2024- with 100% Correct Answers ( A Graded)
- Exam (elaborations) • 50 pages • 2024
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SOCRA EXAM 2024- with 100% Correct Answers ( A 
Graded) 
Electronic signature are currently accepted for any and all records, paper or electronic form. 
True or False? - ANSWER False. The general provisions for electeonic signature criteria apply to 
records that are 
i. Created, modified, maintained, archived, retrieved, or transmitted, in electronic form 
ii. The criteria do not apply to paper records that are or have been transmitted by electronic 
means. 
If the electronic records meet the c...
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SOCRA Exam Questions and answers already graded A+| Updated & Verified | 2024
- Exam (elaborations) • 58 pages • 2024
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Electronic signature are currently accepted for any and all records, paper or electronic form. True or 
False? - False. The general provisions for electeonic signature criteria apply to records that are 
i. Created, modified, maintained, archived, retrieved, or transmitted, in electronic form 
ii. The criteria do not apply to paper records that are or have been transmitted by electronic means. 
If the electronic records meet the criteria specified in 21 CFR 11, thr agency will consider the elect...
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SOCRA CCRP Exam Questions & Answers 2023/2024
- Exam (elaborations) • 23 pages • 2023
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SOCRA CCRP Exam Questions & Answers 2023/2024 
 
 
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 ...
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RAC Practice Exam 1 | 100 Questions with 100% Correct Answers | Verified | Latest Update 2024
- Exam (elaborations) • 18 pages • 2024
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Which of the following is NOT required for compliance under 21 CFR Part 11 (electronic records and 
electronic signatures)? 
A Manually generated timestamped audit trails to record the date and time of operator entries and 
actions that create, modify or delete electronic records. 
B Validation of systems to ensure accuracy 
C Authority checks to ensure that only authorized personell can create, modify or delete electronic 
records. 
D Establishment of and adherence to written procedures - A. 
T...
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US RAC Review Questions RAPS Modules With Complete Solutions Latest 2023/2024 (100% Verified)
- Exam (elaborations) • 38 pages • 2023
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US RAC Review Questions RAPS Modules With Complete Solutions Latest 2023/2024 (100% Verified). drug, which of the following studies would typically be conducted 
first: 
A) 1 month repeat dose toxicology study 
B) Single dose escalation PK study in healthy volunteers 
C) Multiple dose PK study in healthy volunteers 
D) Single dose escalation study in hypertensive patients: B) Single dose 
esca- lation PK study in healthy volunteers 
3. A sponsor must report an unexpected, fatal or life...
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NRCME Exam Questions & Answers 2023-2024
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NRCME Exam Questions & Answers 
What are regulations? - ANS-Laws that must be followed 
What are disqualifying medical conditions? - ANS-Epilepsy 
monocular vision 
hearing loss 
What are guidelines? - ANS-Recommendation to follow but can have raptor ale for variation 
FMCSA medical program responsibilities include: 
Oversee the Department of Transportation. 
Regulation of intrastate commercial motor vehicle operations. 
Conduct and oversee the agency's medical exemption and certificate progr...
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SOCRA Exam Questions And Answers
- Exam (elaborations) • 35 pages • 2024
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SOCRA Exam Questions And Answers 
Electronic signatures are currently accepted for any and all records, paper or electronic form. True or False? - ANS False. The general provisions for electronic signature criteria apply to records that are 
 
i. Created, modified, maintained, archived, retrieved, or transmitted, in electronic form 
 
ii. The criteria do not apply to paper records that are or have been transmitted by electronic means. 
 
If the electronic records meet the criteria specified...
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