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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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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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SOCRA Certification Exam Questions and Answers 2024 100% Correct

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SOCRA Certification Exam Questions and Answers 2024 100% Correct Biometrics - CORRECT 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 - CORRECT ANSWER-An environment in which system access is controlled by persons who are responsible for the content of electronic records that a...

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