1571 - Study guides, Class notes & Summaries
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SOCRA Practice Test Certification Final Exam Questions with 100% Correct answers
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SOCRA Practice Test Certification Final 
Exam Questions with 100% Correct 
answers 
Which of the following is a disclosure of financial interests form? - CORRECT 
ANSWER-FDA Form 3455 
Which of the following is a certification of financial interest form? - CORRECT 
ANSWER-FDA Form 3454 
If the investigator did have financial arrangement with the sponsor, he/she would submit 
the following form: - CORRECT ANSWER-FDA Form 3455 
This form is submitted by sponsor to the FDA prior to the beginnin...
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SOCRA Practice Test Questions And Answers
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SOCRA Practice Test Questions And Answers 
 
Which of the following is a disclosure of financial interests form? - ANS FDA Form 3455 
 
Which of the following is a certification of financial interest form? - ANS FDA Form 3454 
 
If the investigator did have financial arrangement with the sponsor, he/she would submit the following form: - ANS FDA Form 3455 
 
This form is submitted by sponsor to the FDA prior to the beginning of the drug trial - ANS Investigational New Drug Applicati...
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CCRP SOCRA Exam - Practice Exam #1 Questions and Answers 2023
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CCRP SOCRA Exam - Practice Exam #1 Questions and Answers 2023 
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, s...
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Certified Clinical Research Professional (CCRP) Exam | 100% Correct Answers | Verified | Latest 2024 Version
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When isn't an IND application needed? - IND Application is not needed if investigation does not 
support change in labeling 
What information must the general IND include? (21 CFR Part 312.23) - 
FDA Form 1571: 
-FDA Form 1571 cover sheet 
-Table of contents 
-Investigative plan 
-Investigator's brochure 
-Protocol 
-Chemistry/Manufacturing information 
-Pharmacology/toxicology 
-Previous human research/literature information 
-Additional information (drug dependence and abuse potential) 
How...
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Test Bank For International Human Resource Management: Policies and Practices for Multinational Enterprises (Global HRM) 5th Edition By by Ibraiz Tarique, Dennis R. Briscoe, Randall S. Schuler | 2015-2016 | 9780415710534 | Chapter 1-15 | Complete Questio
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Enhance your study sessions with the Test Bank for International Human Resource Management (Global HRM) 5th Edition by Tarique, Briscoe & Schuler. Access the printable PDF instantly, sourced directly from the publisher, covering Chapters 1-15. With detailed questions and answers, it's a vital tool for nursing students looking to excel in their exams
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CITI Training 134 QUESTIONS Graded A+ Solved 2023
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CITI Training 134 QUESTIONS Graded A+ Solved 2023 
What must you file before conducting human clinical trials with an experimental drug? Correct Answer: IND application (Form FDA 1571) 
 
During the clinical development phase of the IND process, what must sponsors do? Correct Answer: Maintain current IND application by amending IND with new Form FDA 1571 and providing FDA with: 
safety updates 
copies of new protocols 
FDA 1572 
Annual Progress reports 
 
this document notifies FDA of relevant...
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SOCRA QUESTIONS AND ANSWERS 2022/2023
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When isn't an IND application needed? - Answer - IND Application is not needed if investigation does not support change in labeling. 
 
What information must the general IND include? 
(21 CFR Part 312.23) - Answer - -FDA Form 1571 
-FDA Form 1571 cover sheet 
-Table of contents 
-Investigative Plan 
-Investigator's brochure 
-Protocol 
-Chemistry/Manufacturing information 
-Pharmacology/Toxicology 
-Previous human research/literature information 
-Additional information (drug dependence and a...
-
SOCRA Practice Test Questions and Answers Already Passed
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SOCRA Practice Test Questions and Answers Already Passed 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 cor...
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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? 
... 
 
 
 
Which of the following is a certification of financial interest form? 
... 
 
 
 
 
 
 
00:27 
01:29 
If the investigator did have financial arrangement with the sponsor, he/she would submit the following form: 
... 
 
 
 
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 Practice Test 2022/2023 with Complete Solutions
- Exam (elaborations) • 10 pages • 2022
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Which of the following is a disclosure of financial interests form? - ANSWER-FDA Form 3455 
 
Which of the following is a certification of financial interest form? - ANSWER-FDA Form 3454 
 
If the investigator did have financial arrangement with the sponsor, he/she would submit the following form: - ANSWER-FDA Form 3455 
 
This form is submitted by sponsor to the FDA prior to the beginning of the drug trial - ANSWER-Investigational New Drug Application (1571) 
 
In the top right corner, form hav...
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