SOCRA Practice Test Certification Final Exam Questions with 100% Correct answers

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 beginning of the drug trial - CORRECT ANSWER-Investigational New Drug Application (1571) In the top right corner, form have OMB number. What does it stand for? - CORRECT ANSWER-Office of Management and Budget The form, which is submitted to the FDA to report an Adverse Event is - CORRECT ANSWER-3500 Medical device adverse events/problems are reported via a form: - CORRECT ANSWER-3500A What is FDA form 1571? - CORRECT ANSWER-Cover-sheet for Investigational New Drug Applications 21 CFR 312 deals with - CORRECT ANSWER-Investigational New Drug Application Investigational new drug means - CORRECT ANSWER-A new drug or biological drug that is used in a clinical investigation The immediate package of an investigational new drug intended for human use shall bear a label with the statement - CORRECT ANSWER-"Caution: New Drug—Limited by Federal (or United States) law to investigational use." Which of the following is not listed on FDA form 1571: - CORRECT ANSWER-Approved informed consent document