Socra exam 2024 - Study guides, Class notes & Summaries

SOCRA CERTIFICATION EXAM 2024 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 for the content of the elec...

SOCRA EXAM 2024- with 100% Correct Answers ( A Graded)

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 ...

SoCRA Certification Exam Question And Answers 2024

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