Socra exam Samenvattingen, Notities en Examens
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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 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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ALL IN ONE BUNDLE SOCRA Certification,, SOCRA CCRP,, SOCRA Practice Test ,, SOCRA Exam Questions and Answers With Complete Solutions 100% | 2023
- Voordeelbundel • 9 items • 2023
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ALL IN ONE BUNDLE SOCRA Certification,, SOCRA CCRP,, SOCRA Practice Test ,, SOCRA Exam Questions and Answers With Complete Solutions 100% | 2023
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CCRP SoCRA Exam Latest Update Rated A
- Tentamen (uitwerkingen) • 12 pagina's • 2024
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CCRP SoCRA Exam Latest Update Rated A 
21 CFR Part 11 Electronic Records; Electronic Signatures 
21 CFR Part 11 Subpart B Electronic Records 
21 CFR Part 11 Subpart C Electronic Signatures 
21 CFR Part 50 Protection of Human Subjects 
21 CFR Part 50 Subpart B Informed Consent of Human Subjects 
21 CFR Part 50 Subpart D Additional Safeguards for Children in Clinical Investigations 
21 CFR Part 56 Institutional Review Board 
21 CFR Part 56 Subpart B Organization and Personnel 
21 CFR Part 56 Subpa...
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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 Exam Questions and Answers | 333 Q&A Graded A+
- Tentamen (uitwerkingen) • 36 pagina's • 2023
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SOCRA Exam Questions and Answers | 333 Q&A Graded A+
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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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Practice Questions for SOCRA exam VERIFIED 2022/2023
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Practice Questions for SOCRA exam VERIFIED 2022/2023Which of the following is a disclosure of financial interests form? 
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Which of the following is a certification of financial interest form? 
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00:27 
01:29 
If the investigator did have financial arrangement with the sponsor, he/she would submit the following form: 
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This form is submitted by sponsor to the FDA prior to the beginning of the drug trial 
Investigational New Drug Application 
 
 
 
In the top rig...
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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+
- Tentamen (uitwerkingen) • 145 pagina's • 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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