Socrate Study guides, Class notes & Summaries

SOCRA Certification Exam Questions and Answers!Rated A+ Answers

PHI Exam 1 (Socrates) Exam Questions And Correct Solutions

Nuremberg Code (1947) - 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 - ANSWER-1. voluntary 2. necessary for results 3. logical design and results 4. avoid unnecessary harm 5. cannot result in death or disablement 6. risk assessment 7. protect subjects against harm 8. qualified investigators 9. right to withdrawal 10. right to end tria...

Does the FDA consider electronic signatures to be as trustworthy and reliable as handwritten paper signatures? - 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 ? - ANSWER-Yes Open system (FDA term) - ANSWER-System access is NOT controlled by people who are responsible for the content of the electronic records in the system. (Like me putting data into CH...

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) Digital Signature - An electronic signature based upon cryptogr...

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. Wh...

Philosophy Exam #1: Socrates Test Questions And Solutions

Socra CCRP Question and answers rated A+Contract Research Organization A person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of a sponsor's trial-related duties and functions. When a short form is used for informed consent the witness must sign the short form or the summary? False-they must sign both What is FDA form 3454 Certification Financial Interests and Arrangements of Clinical Investigators What are the thr...

SOCRA CCRP Exam Flashcards

CCRP SoCRA Exam.