Socra exam Guías de estudio, Notas de estudios & Resúmenes
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SOCRA Exam Questions And Answers
- Examen • 35 páginas • 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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SOCRA EXAM PREP | 2024 / 2025 Newly Updated | Questions and Verified Answers | Highly Rated Guide
- Examen • 675 páginas • 2024
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SOCRA EXAM PREP | 2024 / 2025 Newly Updated | Questions and Verified Answers | Highly Rated Guide Q: What 4 aspects of a trial should a sponsor focus on when monitoring for compliance per 21 CFR 312.56? Answer: 1) Progress of investigations under IND 2) Secure compliance or discontinue investigators that are not compliant and notify FDA 3) Review safety/effectiveness of drug and report safety issues to FDA + make annual reports or progress 4) Notify FDA, all IRBs and all investigators if drug pr...
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CCRP SOCRA Exam - Practice Exam 1
- Examen • 17 páginas • 2024
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CCRP SOCRA Exam - Practice Exam 1 
 
The responsibility for ensuring that the investigator understands a clinical trial lies with which individual/or organization? 
 
A) FDA 
B) IRB 
C) Sponsor 
D) Coordinator 
C) Sponsor 
What is the minimum number of IRB Members? 
 
A) 3 
B) 5 
C) 6 
D) 10 
B) 5 
A significant risk device is defined as an investigational device that is: 
 
A) Intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a subject 
 
B) P...
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SOCRA EXAM QUESTIONS AND ANSWERS
- Examen • 47 páginas • 2024
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SOCRA EXAM QUESTIONS AND ANSWERS
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SOCRA Exam Prep Questions And Answers | 2023/2024 Tests
- Examen • 17 páginas • 2023
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SOCRA Exam Prep Questions And Answers | 2023/2024 Tests 
 
SOCRA Exam Prep Questions And Answers | 2023/2024 Tests
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Practice Questions for SOCRA exam| 105 QUESTIONS| WITH COMPLETE SOLUTIONS
- Examen • 7 páginas • 2022
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Which of the following is a disclosure of financial interests form? Correct Answer: 
 
Which of the following is a certification of financial interest form? Correct Answer: 
 
If the investigator did have financial arrangement with the sponsor, he/she would submit the following form: Correct Answer: 
 
This form is submitted by sponsor to the FDA prior to the beginning of the drug trial Correct Answer: Investigational New Drug Application 
 
In the top right corner, form have OMB number. ...
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CCRP SOCRA Exam | 100% Correct Answers | Verified | Latest 2024 Version
- Examen • 19 páginas • 2024
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CCRP SOCRA Exam | 100% Correct 
Answers | Verified | Latest 2024 Version
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SOCRA Exam Questions and Answers Top Graded 2024
- Examen • 35 páginas • 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...
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SOCRA Exam Questions And Answers With Verified Solutions 2023/2024
- Examen • 36 páginas • 2023
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SOCRA Exam Questions And Answers With Verified Solutions 2023/2024
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CCRP SOCRA Exam - Practice Exam #1 (Practice Test #1 (Ethics, 21 CFR Parts 50, 56, 312, 812; 45 CFR Part 46) Past questions directly from SOCRA) Passed Qs & As
- Examen • 10 páginas • 2024
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CCRP SOCRA Exam - Practice Exam #1 (Practice Test #1 (Ethics, 21 CFR Parts 50, 56, 312, 812; 45 CFR Part 46) Past questions directly from SOCRA) Passed Qs & As
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