Socra 2023 - Study guides, Class notes & Summaries
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SOCRA 2023/2024 EXAM FULL PACKAGE WITH 100% ACCURATE QUESTIONS AND ANSWERS!!
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SOCRA 2023/2024 EXAM FULL PACKAGE WITH 100% ACCURATE QUESTIONS AND ANSWERS!!
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SOCRA Bundled Exams Questions and Answers Latest Update (2023/2024) (Complete and Accurate)
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SOCRA Bundled Exams Questions and Answers Latest Update (2023/2024) (Complete and Accurate)
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SOCRA CCRP EXAM 2023-2024 ACTUAL EXAM 200 QUESTIONS AND CORRECT DETAILED ANSWERS WITH RATIONALES |AGRADE
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SOCRA CCRP EXAM 2023-2024 ACTUAL EXAM 200 QUESTIONS AND CORRECT DETAILED ANSWERS WITH RATIONALES |AGRADESOCRA CCRP EXAM 2023-2024 ACTUAL EXAM 200 QUESTIONS AND CORRECT DETAILED ANSWERS WITH RATIONALES |AGRADE
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SOCRA Certification Questions and Answers 100% Verified | Latest Update 2023
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SOCRA Certification Questions and Answers 100% Verified | Latest Update 2023
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SoCRA CERTIFICATION EXAM AND PRACTICE EXAM 2023-2024 ACTUAL EXAMS 400 QUESTIONS AND CORRECT DETAILED ANSWERS WITH RATIONALES (VERIFIED ANSWERS) | ALREADY GRADED A+
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SoCRA CERTIFICATION EXAM AND PRACTICE EXAM 2023-2024 ACTUAL EXAMS 400 QUESTIONS AND CORRECT DETAILED ANSWERS WITH RATIONALES (VERIFIED ANSWERS) | ALREADY GRADED A+
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SOCRA EXAM PREP | 2023/ 2024 Newly Updated | ALL EXAMS COMBINED| Questions and Verified Answers| Highly Rated Guide
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SOCRA EXAM PREP | 2023 Update | 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 presen...
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CCRP SOCRA Exam - Practice Exam with 100% Correct Answers | Latest 2023/2024
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CCRP SOCRA Exam - Practice Exam with 100% Correct Answers | Latest 2023/2024 
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 
heal...
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SOCRA Certification Exam Q&A 2022/2023
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Does the FDA consider electronic signatures to be as trustworthy and reliable as handwritten paper signatures? - Answer - Yes (although permission to use such e-sigs has to be approved by the FDA) 
 
Does the FDA consider electronic records that meet requirements to be equivalent to handwritten records ? - Answer - Yes 
 
Open system (FDA term) - Answer - System access is NOT controlled by people who are responsible for the content of the electronic records in the system. (Like me putting data i...
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