SOCRA Practice Test Questions with Complete Solutions (Latest 2025) Which of the following is a disclosure of financial interests form? - Correct Answers ✅FDA Form 3455 Which of the following is a certification of financial interest form? - Correct Answers ✅FDA Form 3454 If the investigator did have financial arrangement with the
sponsor, he/she would submit the following form: - Correct
Answers ✅FDA Form 3455 This form is submitted by sponsor to the FDA prior to the beginning of the drug trial - Correct Answers ✅Investigational New Drug Application (1571) In the top right corner, form have OMB number. What does it stand for? - Correct Answers ✅Office of Management and Budget The form, which is submitted to the FDA to report an Adverse Event is - Correct Answers ✅3500 Medical device adverse events/problems are reported via a
form: - Correct Answers ✅3500A
What is FDA form 1571? - Correct Answers ✅Cover-sheet for Investigational New Drug Applications 1 / 3
SOCRA Practice Test Questions with Complete Solutions (Latest 2025) 21 CFR 312 deals with - Correct Answers ✅Investigational New Drug Application Investigational new drug means - Correct Answers ✅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 Answers ✅"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 Answers ✅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 Answers ✅Life threatening adverse drug experience What are the three main basic ethical principles of the Belmont Report? - Correct Answers ✅1. Respect for Persons
- Beneficence
- Justice 2 / 3
SOCRA Practice Test Questions with Complete Solutions (Latest 2025) What are the applications for the Belmont Report? - Correct Answers ✅1. Informed Consent
- Assessment of Risk and Benefits
- Selection of Subjects
What phrase of a drug trial usually includes hundreds to
thousands of volunteers? - Correct Answers ✅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 Answers ✅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 Answers ✅20- 80: Typical number of healthy volunteers used in Phase 1: this phase emphasizes SAFETY.What is Phase 2 of a clinical trial? - Correct Answers
✅100s: Typical number of patients used in Phase 2; this
phase emphasizes EFFECTIVENESS What is Phase 3 of a clinical trial? - Correct Answers ✅1000's :Typical number of patients used in Phase. 3. These
- / 3