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MSF Basic Rider Course Study Questions with Correct Answers 2024

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MSF Basic Rider Course Study Questions with Correct Answers 2024 Name 2 primary differences between cars/trucks and motorcycles. - CORRECT ANSWER-Stability and visibility. What are the problems that these differences cause? - CORRECT ANSWERMotorcycles do not have the stability of cars because they must be balanced, and motorcycles leave you more vulnerable in a crash because there is less protection. Motorcycles are not as readily seen as cars, trucks, or other motor vehicles because ...

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Certified Clinical Research Professional (CCRP) /SOCRA Exam 2024

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Certified Clinical Research Professional (CCRP) /SOCRA Exam 2024 When isn't an IND application needed? - CORRECT 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) - CORRECT 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 ...

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Test for SOCRA CCRP EXAM (Mega certification 2024) Q&A

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Test for SOCRA CCRP EXAM (Mega certification 2024) Q&A 5 - CORRECT ANSWER-The minimum number of IRB members Subjects cannot be enrolled until IRB/IEC approval has been obtained - CORRECT ANSWER-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 - CORRECT ANSWER-The responsibility for ensuring that the investigator understands a clinical trial lies with: A subject has been enrolled...

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SOCRA CCRP Prep Exam Study Questions and Answers 2024 latest

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SOCRA CCRP Prep Exam Study Questions and Answers 2024 latest Timeline of Historical Events - CORRECT ANSWER-Nuremberg Code 1947, Declaration of Helsinki 1964, Belmont Report 1979 The Three Principles of the Belmont Report - CORRECT ANSWER-respect for persons, beneficence, justice Application of Respect for Persons - CORRECT ANSWER-informed consent (autonomy, choose for themselves) Application of Beneficence - CORRECT ANSWER-risk/benefit analysis Application of Justice - CORRECT ANSW...

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CCRP SOCRA Practice Exam 2024 Final questions and correct answers

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CCRP SOCRA Practice Exam 2024 Final questions and correct answers 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 - CORRECT ANSWER-C) Sponsor What is the minimum number of IRB Members? A) 3 B) 5 C) 6 D) 10 - CORRECT ANSWER-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...

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SOCRA Actual Certification Exam 2024 questions and answers A-graded

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SOCRA Actual Certification Exam 2024 questions and answers A-graded Electronic Records - CORRECT ANSWER-Use of electronic records must have procedures to ensure the authenticity, integrity and confidentiality of records. Also, the procedures must ensure the signer cannot readily repudiate the signed records a snot genuine Electronic Records - Audit Trail - CORRECT ANSWER-Electronic records must use secure, computer generated, time-stamped audit trails to independently record the date...

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SOCRA (CCRP) Exam Practice Questions and Answers 2024

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SOCRA (CCRP) Exam Practice Questions and Answers 2024 The Belmont Report's principle of respect for persons incorporates at least two ethical convictions: first, that individuals should be treated as autonomous agents, and second, that: - CORRECT AND ANSWER-Persons with diminished autonomy are entitled to protection. Which of the following is an example of how the principle of beneficence can be applied to a study employing human subjects? - CORRECT AND ANSWER-Determining that the...

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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 Certification Exam Guide 2024 with correct answer

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SOCRA Certification Exam Guide 2024 with correct answer Does the FDA consider electronic signatures to be as trustworthy and reliable as handwritten paper signatures? - CORRECT ANSWER-Yes (although permission to use such e-sigs has to be approved by the FDA) Does the FDA consider electronic records that meet requirements to be equivalent to handwritten records ? - CORRECT ANSWER-Yes Open system (FDA term) - CORRECT ANSWER-System access is NOT controlled by people who are responsible...

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CCRP SoCRA Exam Cert Exam Questions with Verified Answers 2024

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CCRP SoCRA Exam Cert Exam Questions with Verified Answers 2024 21 CFR Part 11 - CORRECT ANSWER-Electronic Records; Electronic Signatures 21 CFR Part 11 Subpart B - CORRECT ANSWER-Electronic Records 21 CFR Part 11 Subpart C - CORRECT ANSWER-Electronic Signatures 21 CFR Part 50 - CORRECT ANSWER-Protection of Human Subjects 21 CFR Part 50 Subpart B - CORRECT ANSWER-Informed Consent of Human Subjects 21 CFR Part 50 Subpart D - CORRECT ANSWER-Additional Safeguards for Children in Clinical ...

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