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Package Deal For SOCRA Practice Test Questions with Verified Answers Top-Rated 2024

Package Deal For SOCRA Practice Test Questions with Verified Answers Top-Rated 2024

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SoCRA Certification Exam Verified Questions and Answers 2024 Graded A

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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 ...

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SOCRA Exam Study Guide 100%Verified Graded A 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'...

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SOCRA Practice Test Questions with Verified Answers Top-Rated 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...

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SOCRA Certification Exam Questions 2024 With Updated Solutions

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SOCRA Certification Exam Questions 2024 With Updated Solutions

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CCRP SoCRA Exam 2024 Study Guide

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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 S...

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SOCRA Exam Questions and Answers Top Graded 2024

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Electronic signature are currently accepted for any and all records, paper or electronic form. True or False? - False. The general provisions for electeonic signature criteria apply to records that are i. Created, modified, maintained, archived, retrieved, or transmitted, in electronic form i...

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MEGA SOCRA CCRP EXAM CONTENT STUDY GUIDE 2024

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5 The minimum number of IRB members Subjects cannot be enrolled until IRB/IEC approval has been obtained In a non-emergency situation, under which of the following conditions, if any, may subjects be enrolled into a study prior to IRB/IEC approval? The Sponsor The responsibility for ensuring th...

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CCRP SOCRA Exam - Practice Exam 1 Study Questions and Answers 2024 Top Graded

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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 ...

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CCRP Exam Verified Questions And Answers Graded A 2024

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How many days does a sponsor have to report an emergency use of an IP to the FDA? - 5 working days How many members must sit on an IRB? - 5 How long must an IRB retain records per 21 CFR 56? - 3 years after completion of research What are the criteria for IRB approval of research? (7) - 1. ...

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