Socra exam 2024 - Study guides, Class notes & Summaries

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 ...

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...

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 Certification Exam Question And Answers 2024

SOCRA CCRP EXAM ACTUAL EXAM 2024 PRACTICE QUESTIONS AND CORRECT DETAILED ANSWERS WITH RATIONALES |AGRADE

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SoCRA Certification Exam 2024 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) - ANSWER Biometrics 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) - ...

SOCRA Practice Test Exam Question And Answers 2024

Socra Ccrp Exam 2024 With Complete Solutions Latest Update