SOCRA Practice Test Questions with 100% Verified 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." 1 / 2
Which of the following is not listed on FDA form 1571: - Correct Answer Approved informed consent document "Any adverse drug experience that places the patient or subject, in the view of the investigator, at immediate risk of death from the reaction as it occurred" Is... - Correct Answer Life threatening adverse drug experience What are the three main basic ethical principles of the Belmont Report? - Correct Answer 1. Respect for Persons
- Beneficence
- Justice
- Assessment of Risk and Benefits
- Selection of Subjects
What are the applications for the Belmont Report? - Correct Answer 1. Informed Consent
What phrase of a drug trial usually includes hundreds to thousands of volunteers? - Correct Answer Phase 3: These studies gather more information about safety and effectiveness, study different populations and different dosages, and uses the drug in combination with other drugs.What is a drug as defined by the FDA? - Correct Answer A drug is an product that is intended for use in the diagnosis, cure mitigation, treatment, or prevention of disease; and that is intended to affect the structure or any function of the body.What is Phase 1 of a clinical trial? - Correct Answer 20-80: Typical number of healthy volunteers used in
Phase 1: this phase emphasizes SAFETY.
What is Phase 2 of a clinical trial? - Correct Answer 100s: Typical number of patients used in Phase 2; this phase emphasizes EFFECTIVENESS What is Phase 3 of a clinical trial? - Correct Answer 1000's :Typical number of patients used in Phase. 3.These studies gather more information about safety and effectiveness, study different populations and different dosages, and uses the drug in combination with other drugs.
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