Socra final exam test - Study guides, Class notes & Summaries

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 - CORRECT ANSWER-Investigational New Drug Application (1571) In...

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 - CORRECT ANSWER-Investigational New Drug Application (1571) In...

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 - CORRECT ANSWER-Investigational New Drug Application (1571) In...

Socra CCRP exam questions and answers with complete top solutions Contract Research Organization A person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of a sponsor's trial-related duties and functions. When a short form is used for informed consent the witness must sign the short form or the summary? False-they must sign both 00:37 01:41 What is FDA form 3454 Certification Financial Interests and Arrangements o...

CCRP SOCRA Exam VERIFIED CFR Part 11 Electronic Records; Electronic Signatures 21 CFR Part 11 Subpart B Electronic Records 21 CFR Part 11 Subpart C Electronic Signatures 21 CFR Part 50 Protection of Human Subjects 21 CFR Part 50 Subpart B Informed Consent of Human Subjects 21 CFR Part 50 Subpart D Additional Safeguards for Children in Clinical Investigations 21 CFR Part 56 Institutional Review Board 21 CFR Part 56 Subpart B Organization and Personnel ...

SOCRA Final Exam Test 2023 (Questions and Answers) Latest Update Graded A+. How many days does Physician or Sponsor have to submit written summary of expanded access to the FDA after use? - correct answers15 days 21 CFR Part 312.34 - correct answersTreatment use of an Investigational new drug. During which phases is a treatment protocol usually made available? - correct answersDuring Phase 3 but if data is compelling, may be available during Phase 2, OR, after all clinical trials have been...

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...