Form 1571 - Study guides, Class notes & Summaries
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CCRP SoCRA Exam Latest Update Rated A
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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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SOCRA Practice Test 2024/25
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SOCRA Practice Test 2024/25 
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 s...
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SOCRA PRACTICE TEST EXAM 2024 WITH 100% CORRECT ANSWERS
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SOCRA PRACTICE TEST EXAM 2024 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 beginning of the drug trial - co...
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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 exam| 168 questions and answers already graded A+| Updated & Verified | 2024
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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)
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CCRC Exam Study Guide
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Protocols - Answer- 1) General Information 
2) Background info 
3) Trial objectives and purpose 
4) Trial design 
5) Selection and withdrawal of subjects 
6) Treatment of Subjects 
7) Assessment of Efficacy 
8) Assessment of Safety 
9) Statistics 
10) Source Data/Docs 
11) Quality control/assurance 
12) ethics 
13) data handling and record keeping 
14) financing and insurance 
15) publication policy 
16) supplements 
 
Phase 1 - Answer- -intro of new drug/investigational product into humans 
-he...
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SOCRA Practice Test Questions and answers already graded A+| Updated & Verified | 2024
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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. What does it stand f...
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SOCRA Exam (Latest 2024/ 2025 Update) Questions and Verified Answers| 100% Correct| Grade A+
- Exam (elaborations) • 23 pages • 2024
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SOCRA Exam (Latest 2024/ 2025 Update) Questions and Verified 
Answers| 100% Correct| Grade A+ 
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 ...
-
SOCRA Practice Test 2024/25
- Exam (elaborations) • 21 pages • 2024
-
- $12.49
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SOCRA Practice Test 2024/25 
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 s...
-
CCRP SOCRA Exam - Practice Exam #1 Questions and Answers 2023
- Exam (elaborations) • 11 pages • 2023
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Available in package deal
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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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