45 cfr 46 - Study guides, Class notes & Summaries

ACRP-CP Exam Questions With Latest Solutions 2024 Belmont Report (1979) - answerethical principles and guidelines for the protection of human subjects of research. respect for persons - answerindividuals should be treated as autonomous agents and persons with diminished autonomy are entitled to protection An autonomous person - answerA person capable of deliberation about personal goals and of acting under the direction of such deliberation Beneficence - answerDo not harm and maximize po...

SOCRA CCRP Exam Review questions and answers, VERIFIED/ April 30 1996 - -ICH GCP Development Date Quality - -ICH Q Efficacy - -ICH E Safety - -ICH S Multidisciplinary - -ICH M guidance for industry, consolidated guideance - -ICH E 6 Clinical Safety Data Management Definitions and Standards - -ICH E2A Safety pharmacology studies for human pharmaceuticals - -ICH S7A Electronic records, electronic signatures - -21 CFR Part 11 Informed Consent - -21 CFR Part 50 Financial Disclosures - -...

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 needed ...

ACRP-CP Exam Questions With Latest Solutions 2024 Belmont Report (1979) - answerethical principles and guidelines for the protection of human subjects of research. respect for persons - answerindividuals should be treated as autonomous agents and persons with diminished autonomy are entitled to protection An autonomous person - answerA person capable of deliberation about personal goals and of acting under the direction of such deliberation Beneficence - answerDo not harm and maximize po...

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...

Laws - passed by national legislative bodies; establish authority of national regulatory body Regulations - Passed by regulatory authorities; controls how medical products are investigated and approved; have effect of law guidance - "current thinking" of regulatory bodies; non-binding ICH - Developed to keep people doing things the same way across the world; international effort to harmonize the technical requirements for product registration SOPs - developed by an organization (sp...

IRB and IACUC Questions and Answers with Verified Solutions 21 CFR 50 and 56 regulate A.) Animal research B.) Exempted research C.) non-consent research D.) Research regulated by the FDA D.) Research regulated by the FDA 45 CFR 46 is also known as A.) the Golden Rule B.) the common rule C.) the consent form D.) none of the above B.) the common rule A human research protocol must go through full committee review if it involves "vulnerable" populations. Which of the followin...

Exam(Elaborations)ACRP-CP 2023 Correctly Answered Belmont Report (1979) - Answer ️️ -ethical principles and guidelines for the protection of human subjects of research. respect for persons - Answer ️️ -individuals should be treated as autonomous agents and persons with diminished autonomy are entitled to protection An autonomous person - Answer ️️ -A person capable of deliberation about personal goals and of acting under the direction of such deliberation Beneficence - Answer...

ACRP-CP 2024 Exam(Elaborations) Correctly Answered!! Graded A+ Belmont Report (1979) - ️️ -ethical principles and guidelines for the protection of human subjects of research. respect for persons - ️️ -individuals should be treated as autonomous agents and persons with diminished autonomy are entitled to protection An autonomous person - ️️ -A person capable of deliberation about personal goals and of acting under the direction of such deliberation Beneficence - ️️ -Do not...

CITI Training Complete Questions And Answers With Verified Solutions A subject participates in a drug study because treatment is available at no or reduced cost, and he could not otherwise afford it. This is an example of A. Institutional vulnerability B. Communicative vulnerability C. Economic vulnerability D. Social vulnerability Correct Answer: C. Economic vulnerability According to the authors, there are four common abuses that historically are described as giving rise to vulnerabi...