21 cfr part 50 Study guides, Class notes & Summaries
Looking for the best study guides, study notes and summaries about 21 cfr part 50? On this page you'll find 344 study documents about 21 cfr part 50.
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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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Gleim Private Pilot FAA Knowledge Test Guide
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Gleim Private Pilot FAA Knowledge Test Guide 
 
 
Gleim Private Pilot FAA Knowledge Test Guide 
 
What is one purpose of wing flaps? 
To enable the pilot to make steeper approaches to a landing without increasing the airspeed. 
One of the main functions of flaps during approach and landing is to: 
Increase the angle of descent without increasing the airspeed. 
What is the purpose of the rudder on an airplane? 
To control yaw. 
Which is not a primary flight control surface? 
A. Flaps 
B. Stabilat...
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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? 
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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: 
... 
 
 
 
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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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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SOCRA Certification Exam 2022/2023 with Complete Solution
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Biometrics - ANSWER A method of verifying an individual's identity based on measurement of the individual's physical features or repeatable actions where those features and or actions are both unique to that individual and measurable. (21 CFR, Sec. 11.3) 
 
Closed System - ANSWER An environment in which system access is controlled by persons who are responsible for the content of electronic records that are on the system. (21 CFR, Sec. 11.3) 
 
Digital Signature - ANSWER An electronic signatur...
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Lead Inspector/Risk Assessor | ALL QUESTIONS AND ANSWERS 2023 GRADED A+!!
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Lead Inspector/Risk Assessor | ALL QUESTIONS AND ANSWERS 2023 GRADED A+!! 
 
Permanent abatement options include... - Paint removal, component removal, enclosure, encapsulation 
Lead Inspector - A certified individual who conducts a surface-by-surface investigation 
 to determine the presence of lead-based paint. 
Lead-based paint - 1 mg/cm2 
5000micrograms/g = 5000ppm 
.5% by weight 
What is lead based paint? - any surface coating containing at least 1 miligram per square centimeter of lead...
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UST Test Questions And Answers Latest Updated 2024/2025 (Graded A+)
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UST Test Questions And Answers Latest Updated 2024/2025 (Graded A+) The regulations to enforce compliance of underground storage tank systems in the state 
are found in? 
a.) Code of Federal Regulations, 40 CFR Part 281 
b.) California Code of Regulations, Title 23, Chapter 16 
c.) Code of Federal Regulations, 40 CFR Part 280 
d.) California Code of Regulations, Title 23, Chapter 17 - Correct answer b.) 
California Code of Regulations; Title 23, Chapter 16 
2) By definition an "underground stor...
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SoCRA Certification Exam 2023 with complete answers
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SoCRA Certification Exam 2023 with complete answers 
Biometrics 
A method of verifying an individual's identity based on measurement of the individual's physical features or repeatable actions where those features and or actions are both unique to that individual and measurable. (21 CFR, Sec. 11.3) 
 
 
 
Closed System 
An environment in which system access is controlled by persons who are responsible for the content of electronic records that are on the system. (21 CFR, Sec. 11.3) 
 
 
 
Digi...
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SOCRA Practice Test Questions And Answers 2022
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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. Wh...
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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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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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SOCRA CCRP Exam Prep Questions with Approved Answers | Latest 2023/2024
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SOCRA CCRP Exam Prep Questions with Approved Answers | Latest 2023/2024 
April 30 1996 ️ ICH GCP Development Date 
Quality ️ ICH Q 
Efficacy ️ ICH E 
Safety ️ ICH S 
Multidisciplinary ️ ICH M 
guidance for industry, consolidated guideance ️ ICH E 6 
Clinical Safety Data Management Definitions and Standards ️ ICH 
E2A 
Safety pharmacology studies for human pharmaceuticals ️ ICH S7A 
Electronic records, electronic signatures ️ 21 CFR Part 11 
Informed Consent ️ 21 CFR Part 50 
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