SOCRA

SOCRA EXAM CERTIFICATION ACTUAL EXAM

SoCRA Certification Exam Complete Questions with Graded A+ Answers Biometrics 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 An environment in which system access is controlled by persons who are responsible for the content of electronic records that are on the system. (21 CFR, Sec. 11.3...

SoCRA Certification Exam Complete Questions with Graded A+ Answers Biometrics 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 An environment in which system access is controlled by persons who are responsible for the content of electronic records that are on the system. (21 CFR, Sec. 11.3...

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 Application Correct Answer: CFR Title 21: 312 New Drug Application Correct Answer: CFR Title 21: 314 Investigational Device Exemption Correct Answer: CFR Title 21: 812 Pre- Market Approval ...

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 Answer: This form is submitted by sponsor to the FDA prior to the beginning of the drug trial Correct Answer: Investigational New Drug Application In the top right corner, form have OMB number. ...

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: An environment in which system access is controlled by persons who are responsible for the content of electronic records that are on the system. (21 CFR, Sec. 11.3) Digital Signature Correct Answer:...

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 regulations made? Correct Answer: 1980 *1981 for the HHS and revised FDA Regulations. What year was GCP and HIPAA created? Correct Answer: 1996 What is the National Research Act? Correct Answer: ...

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) I...