21 cfr 11 Study guides, Class notes & Summaries
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SOCRA Practice Test Questions And Answers 2022
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Which of the following is a disclosure of financial interests form? 
FDA Form 3455 
 
 
 
Which of the following is a certification of financial interest form? 
FDA Form 3454 
 
 
 
If the investigator did have financial arrangement with the sponsor, he/she would submit the following form: 
FDA Form 3455 
 
 
 
This form is submitted by sponsor to the FDA prior to the beginning of the drug trial 
Investigational New Drug Application (1571) 
 
 
 
In the top right corner, form have OMB number. Wh...
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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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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 CCRP Exam Questions And Answers
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SOCRA CCRP Exam Questions And Answers 
 
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 ...
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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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SOCRA Exam Questions and Answers | 333 Q&A Graded A+
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SOCRA Exam Questions and Answers | 333 Q&A Graded A+
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SOCRA CCRP Exam Prep Questions with Approved Answers | Latest 2023/2024
- Exam (elaborations) • 20 pages • 2023
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SOCRA CCRP Exam Prep Questions with Approved Answers | Latest 2023/2024 
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 
...
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SOCRA CCRP Exam Questions and Answers 100% Solved
- Exam (elaborations) • 17 pages • 2024
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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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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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