Socra exam test 2023 Study guides, Class notes & Summaries

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SOCRA EXAM TEST 2023 - QUESTIONS and ANSWERS, Latest Update Graded 100%.
  • SOCRA EXAM TEST 2023 - QUESTIONS and ANSWERS, Latest Update Graded 100%.

  • Exam (elaborations) • 19 pages • 2023
  • SOCRA EXAM TEST 2023 -| QUESTIONS and ANSWERS, Latest Update Graded 100%. When must an IND amendment be submitted and which section outlines this? - correct answers(21 CFR Part 312.31) -If there are changes to the protocol that affects safety of subjects, scientific quality of study, or scope of investigation -If a new Investigator is added to the study -Information amendments must be submitted for chemistry/microbiology, pharm/toxicology, or clinical Other submissions: --IND safety rep...
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SOCRA EXAM TEST 2023 | QUESTIONS WITH ANSWERS, Latest Update Graded A+
  • SOCRA EXAM TEST 2023 | QUESTIONS WITH ANSWERS, Latest Update Graded A+

  • Exam (elaborations) • 19 pages • 2023
  • SOCRA EXAM TEST 2023 | QUESTIONS WITH ANSWERS, Latest Update Graded A+. When isn't an IND application needed? - correct answersIND 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 answers-FDA Form 1571 -FDA Form 1571 cover sheet -Table of contents -Investigative Plan -Investigator's brochure -Protocol -Chemistry/Manufacturing information -Pharmacology/Toxicology -Previous hu...
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SOCRA Practice Test Exam With 100% Correct Answers 2023
  • SOCRA Practice Test Exam With 100% Correct Answers 2023

  • Exam (elaborations) • 10 pages • 2023
  • SOCRA Practice Test Exam With 100% Correct Answers 2023
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SOCRA CCRP 2023 Exam Questions and Answers All Correct
  • SOCRA CCRP 2023 Exam Questions and Answers All Correct

  • Exam (elaborations) • 17 pages • 2023
  • SOCRA CCRP 2023 Exam Questions and Answers All Correct FDA Part 11 - Answer-electronic signatures are of the same validity as handwritten signatures, must provide 2 identifiers and verify identification of signer FDA Part 50 - Answer-Food and Drugs, and ICF FDA Part 56 - Answer-IRBs FDA Part 312 - Answer-investigational new drug application FDA Part 812 - Answer-investigational drug exemption FDA Form 482 - Answer-Notice of inspection FDA Form 483 - Answer-Letter of investiga...
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SoCRA Certification Exam (2023-2024) – Questions and Answers (100% Correct)
  • SoCRA Certification Exam (2023-2024) – Questions and Answers (100% Correct)

  • Exam (elaborations) • 12 pages • 2023
  • SoCRA Certification Exam (2023-2024) – Questions and Answers (100% Correct)SoCRA Certification Exam (2023-2024) – Questions and Answers (100% Correct)SoCRA Certification Exam (2023-2024) – Questions and Answers (100% Correct)Biometrics - 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 ...
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