What is 45 cfr part 46 - Study guides, Class notes & Summaries

CCRP SoCRA Exam Latest Update Rated A 21 CFR Part 11 Electronic Records; Electronic Signatures 21 CFR Part 11 Subpart B Electronic Records 21 CFR Part 11 Subpart C Electronic Signatures 21 CFR Part 50 Protection of Human Subjects 21 CFR Part 50 Subpart B Informed Consent of Human Subjects 21 CFR Part 50 Subpart D Additional Safeguards for Children in Clinical Investigations 21 CFR Part 56 Institutional Review Board 21 CFR Part 56 Subpart B Organization and Personnel 21 CFR Part 56 Subpa...

Certification for IRB Professionals (CIP) Exam Complete Q&A 2023. According to the Belmont Report, respect for persons usually demands that subjects... According to the Belmont Report, the moral requirement that there be fair outcomes in the selection of research subjects, expresses the principle of: - A poorly designed protocol is considered unethical because... - When should an IRB suspend or terminate approval of research? - A quorum for a convened IRB meeting requires the pr...

CCRP SOCRA Exam - Practice Exam #1 Questions and Answers 2023 The responsibility for ensuring that the investigator understands a clinical trial lies with which individual/or organization? A) FDA B) IRB C) Sponsor D) Coordinator C) Sponsor What is the minimum number of IRB Members? A) 3 B) 5 C) 6 D) 10 B) 5 A significant risk device is defined as an investigational device that is: A) Intended as an implant and presents a potential for serious risk to the health, s...

SoCRA Certification Exam 2023 with complete 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) Digi...

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...

SOCRA Test practice Questions and Answers 2024 The Purpose of the IRB is to: -Answer-Protect the rights and welfare of human subjects in research What is the minimum number of members required by an IRB -Answer-5 Which of the following are necessary to waive consent? A.Subject is unable to give consent B.No time or unable to contact next of kin C.Life-Threatening Condition D.No other treatment available E.All of the above -Answer-all of the above This form is used for the mandatory rep...

SOCRA Test practice Questions and Answers 2024 The Purpose of the IRB is to: -Answer-Protect the rights and welfare of human subjects in research What is the minimum number of members required by an IRB -Answer-5 Which of the following are necessary to waive consent? A.Subject is unable to give consent B.No time or unable to contact next of kin C.Life-Threatening Condition D.No other treatment available E.All of the above -Answer-all of the above This form is used for the mandatory rep...

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 ...

Pharmacist mission improve public health through ensuring the safe, effective, and appropriate use of medications 4 main clinical pharmacy practice models pharmaceutical care MTM comprehensive med mgmt CDTM Goal of pharmaceutical care? optimize health related quality of life, achieve positive clinical outcomes Medication therapy management definition? CMS servive or group of services that optimizes therapeutic outcomes for individual patients. Optimize outcomes throug...

Pharmacist mission improve public health through ensuring the safe, effective, and appropriate use of medications 4 main clinical pharmacy practice models pharmaceutical care MTM comprehensive med mgmt CDTM Morisky Questionnaire predictive adherence measurement tool - 1+ drugs in a regimen for a particular disease - screen for knowledge gaps and motivational issues Adherence Estimator Used only for individual drugs Pt Ed Materials Assessment (PEMAT) tool usa...