SOCRA Practice Test Latest Updated Graded A+
Which of the following is a disclosure of financial interests form? - ANSWER FDA Form 3455 Which of the following is a certification of financial interest form? - ANSWER FDA Form 3454 If the investigator did have financial arrangement with the sponsor, he/she would submit the following form: - ANSWER FDA Form 3455 This form is submitted by sponsor to the FDA prior to the beginning of the drug trial - ANSWER Investigational New Drug Application (1571) In the top right corner, form have OMB number. What does it stand for? - ANSWER Office of Management and Budget The form, which is submitted to the FDA to report an Adverse Event is - ANSWER 3500 Medical device adverse events/problems are reported via a form: - ANSWER 3500A What is FDA form 1571? - ANSWER Cover-sheet for Investigational New Drug Applications 21 CFR 312 deals with - ANSWER Investigational New Drug Application Investigational new drug means - 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 - ANSWER
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