Socrate Guides d'étude, Notes de cours & Résumés

Electronic signature are currently accepted for any and all records, paper or electronic form. True or False? - 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 meet the criteria specified in 21 CFR 11, thr agency will consider ...

Nuremberg Code (1947) - ANSWERA 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 - ANSWER1. 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...

SOCRA CCRP Exam (2023/2024) Rated A Timeline of Historical Events Nuremberg Code 1947, Declaration of Helsinki 1964, Belmont Report 1979 The Three Principles of the Belmont Report respect for persons, beneficence, justice Application of Respect for Persons informed consent (autonomy, choose for themselves) Application of Beneficence risk/benefit analysis Application of Justice appropriate selection of patients (equality) Language Level ICF 6th-8th grade 8 basic elements of ICF 1. purpose, ...

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Contract Research Organization correct answers 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? correct answers False-they must sign both What is FDA form 3454 correct answers Certification Financial Interests and Arrangements of Clinical Investigators What are the three main ...

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 answe...

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...

Nuremberg Code (1947) - 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 - 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 trial if nee...

Nuremburg Code -ANSWER The first set of principles outlining professional ethics for clinical research. Nuremburg Code elements -ANSWER 1. Voluntary informed consent 2. research benefits society 3. should be based on prior animal work 4. avoid suffering and injury 5. research where death and disabling injury is expected shouldn't be conducted 6. risks should be justified 7. proper preparations and adequate facilities 8. conducted by scientifically qualified 9. subjects can withdra...

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