Study guides, Class notes & Summaries

SOCRA CERTIFICATION EXAM 2024 Does the FDA consider electronic signatures to be as trustworthy and reliable as handwritten paper signatures? - correct answer Yes (although permission to use such e-sigs has to be approved by the FDA) Does the FDA consider electronic records that meet requirements to be equivalent to handwritten records ? - correct answer Yes Open system (FDA term) - correct answer System access is NOT controlled by people who are responsible for the content of the elec...

SOCRA EXAM 2024 -25 WITH 100% ACCURATE SOLUTIONS Electronic signature are currently accepted for any and all records, paper or electronic form. True or False? - correct answer False. The general provisions for electeonic signature criteria apply to records that are i. Created, modified, maintained, archived, retrieved, or transmitted, in electronic form ii. The criteria do not apply to paper records that are or have been transmitted by electronic means. If the electronic records m...

SOCRA PRACTICE TEST EXAM 2024 WITH 100% 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 - co...

SOCRA (CCRP) EXAM 2024 WITH 100% ACCURATE SOLUTIONS The Belmont Report's principle of respect for persons incorporates at least two ethical convictions: first, that individuals should be treated as autonomous agents, and second, that: - correct answer Persons with diminished autonomy are entitled to protection. Which of the following is an example of how the principle of beneficence can be applied to a study employing human subjects? - correct answer Determining that the study has a m...

The Belmont Report's principle of respect for persons incorporates at least two ethical convictions: first, that individuals should be treated as autonomous agents, and second, that: - CORRECT AND ANSWER-Persons with diminished autonomy are entitled to protection. Which of the following is an example of how the principle of beneficence can be applied to a study employing human subjects? - CORRECT AND ANSWER-Determining that the study has a maximization of benefits and a minimization ...

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...

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...

Does the FDA consider electronic signatures to be as trustworthy and reliable as handwritten paper signatures? - CORRECT ANSWER-Yes (although permission to use such e-sigs has to be approved by the FDA) Does the FDA consider electronic records that meet requirements to be equivalent to handwritten records ? - CORRECT ANSWER-Yes Open system (FDA term) - CORRECT ANSWER-System access is NOT controlled by people who are responsible for the content of the electronic records in the system. (...

Respect for persons, justice, beneficence List the three ethical principles of the Belmont report Experiment that involves a test article and one or more human subjects - does not include experiments which are nonclinical lab studies Define clinical investigation Someone who is or becomes A participate in research either as a recipient of the test article or as a control Human subject is: Life threatening circumstances deem use of test article necessary, inability to communicate or ...

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? Of...