SOCRA CCRP Practice Test with complete Solutions | Latest 2023/2024

SOCRA CCRP Practice Test with complete Solutions | Latest 2023/2024 Which of the following is a disclosure of financial interests form? ️ FDA Form 3455 Which of the following is a certification of financial interest form? ️ FDA Form 3454 If the investigator did have financial arrangement with the sponsor, he/she would submit the following form: ️ FDA Form 3455 This form is submitted by sponsor to the FDA prior to the beginning of the drug trial ️ Investigational New Drug Application (1571) In the top right corner, form have OMB number. What does it stand for? ️ Office of Management and Budget The form, which is submitted to the FDA to report an Adverse Event is ️ 3500 Medical device adverse events/problems are reported via a form: ️ 3500A What is FDA form 1571? ️ Cover-sheet for Investigational New Drug Applications 21 CFR 312 deals with ️ Investigational New Drug Application Investigational new drug means ️ 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 ️ "Caution: New Drug—Limited by Federal (or United States) law to investigational use." Which of the following is not listed on FDA form 1571: ️ Approved informed consent document