21 cfr 11 - Study guides, Class notes & Summaries
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SOCRA EXAM 2024 -25 WITH 100% ACCURATE SOLUTIONS
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SOCRA EXAM 2024 -25 WITH 100% ACCURATE SOLUTIONS 
 
 
Electronic signature are currently accepted for any and all records, paper or electronic form. True or False? - correct 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 m...
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SOCRA CCRP Exam Questions With 100% Correct Answers.
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SOCRA CCRP Exam Questions With 100% Correct Answers. 
April 30 1996 - correct answer ICH GCP Development Date 
 
Quality - correct answer ICH Q 
 
Efficacy - correct answer ICH E 
 
Safety - correct answer ICH S 
 
Multidisciplinary - correct answer ICH M 
 
guidance for industry, consolidated guideance - correct answer ICH E 6 
 
Clinical Safety Data Management Definitions and Standards - correct answer ICH E2A 
 
Safety pharmacology studies for human pharmaceuticals - correct answer ICH S7A 
 ...
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CCRP SoCRA Exam Cert Exam Questions with Verified Answers 2024
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CCRP SoCRA Exam Cert Exam 
Questions with Verified Answers 2024 
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 ...
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SOCRA Exam Questions And Answers 2022/2023
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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 criteria specified in 21 CFR 11, thr agency will con...
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CCRP Exam Graded A+
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CCRP Exam Graded A+ 
21 CFR 11 - ANSElectronic Records; Electronic Signatures 
B - Electronic Records 
C - Electronic Signatures 
21 CFR 50 - ANSProtection of Human Subjects/Informed Consent 
B - Informed Consent 
50.23 - Exception from General 
50.24 - Exception from Informed Consent Requirements for Emergency Research 
50.25 - Elements of Informed Consent 
50.27 - Documentation of Informed Consent 
D - Additional Safeguards for Children 
21 CFR 50 Subpart B - ANS50.25 Elements of Informed Cons...
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CCRP - Certified Clinical Research Associate Exam with Questions and Complete Solutions (A+ Guaranteed)
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21 CFR 11 correct answers Electronic Records; Electronic Signatures 
B - Electronic Records 
C - Electronic Signatures 
21 CFR 50 correct answers Protection of Human Subjects/Informed Consent 
B - Informed Consent 
50.23 - Exception from General 
50.24 - Exception from Informed Consent Requirements for Emergency Research 
50.25 - Elements of Informed Consent 
50.27 - Documentation of Informed Consent
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Device RAC Exam Questions and Answers | Latest Update | 2024/2025 | Already Passed
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Device RAC Exam Questions and 
Answers | Latest Update | 2024/2025 | 
 
Already Passed 
 
What is the role of regulatory affairs professionals in the medical device industry? 
A) To ensure compliance with regulations and guidelines 
B) To create marketing strategies 
C) To design medical devices 
D) To conduct clinical trials 
 
What does a De Novo classification request pertain to? 
A) Devices that are already on the market 
B) Devices that are novel and have no predicate 
C) Devices undergoing...
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SOCRA CCRP Exam Questions and Answers 100% Solved
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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 
 
Financial Disclosures - ANSWER -21 CFR Part 54...
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SOCRA CCRP Exam Questions with 100% Correct Answers
- Exam (elaborations) • 17 pages • 2024
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April 30 1996 ICH GCP Development Date 
 
Quality ICH Q 
 
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 21 CFR Part 50 
 
Financial Disclosures 21 CFR Part 54 
 
Institutional Review Board 21 CFR Part 56 
 
IND Appli...
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RAC Practice Exam 1 Questions with 100% Correct Answers | Latest Version 2024 | Verified
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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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