SOCRA TESTS COMPILATION BUNDLE

Nuremberg Code (1947) Correct Answer: A research ethics code that arose in response to the Nazis' inhumane experimentation (nuremberg trials) - holocaust, racial hygiene / eugenics / master race. The Nuremberg Code - 10 points Correct Answer: 1. voluntary 2. necessary for results 3. logical ...

5 Correct Answer: The minimum number of IRB members Subjects cannot be enrolled until IRB/IEC approval has been obtained Correct Answer: In a non-emergency situation, under which of the following conditions, if any, may subjects be enrolled into a study prior to IRB/IEC approval? The Sponsor...

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 f...

How long is the reporting period for equity interest and significant payments? Correct Answer: study period plus one year Pre-Study Documents (Essential Documents) Correct Answer: FDA 1572 (drug) or signed investigators agreement (devices) CVs, licenses, ect Fully executed contract and budget ...

Belmont Report was created as part of? Correct Answer: The national Research Act of 1974. Who was the Belmont Report formulated by? Correct Answer: The National Commission for the protection of human subjects in biomedical and behavioral research. What year was the publication of the FDA reg...

Biometrics Correct Answer: A method of verifying an individual's identity based on measurement of the individual's physical features or repeatable actions where those features and or actions are both unique to that individual and measurable. (21 CFR, Sec. 11.3) Closed System Correct Answer: A...

Which of the following is a disclosure of financial interests form? Correct Answer: Which of the following is a certification of financial interest form? Correct Answer: If the investigator did have financial arrangement with the sponsor, he/she would submit the following form: Correct Ans...

Electronic Records, Electronic Signatures Correct Answer: CFR Title 21: Part 11 Informed Consent Correct Answer: CFR Title 21: Part 50 Financial Disclosure Correct Answer: CFR Title 21: Part 54 Instiutional Review Board Correct Answer: CFR Title 21: Part 56 Investigational new Drug A...