Icf monitoring c - Study guides, Class notes & Summaries

SOCRA EXAM PREP | 2023 Update | Questions and Verified Answers| Highly Rated Guide Q: What 4 aspects of a trial should a sponsor focus on when monitoring for compliance per 21 CFR 312.56? Answer: 1) Progress of investigations under IND 2) Secure compliance or discontinue investigators that are not compliant and notify FDA 3) Review safety/effectiveness of drug and report safety issues to FDA + make annual reports or progress 4) Notify FDA, all IRBs and all investigators if drug presen...

Nursing Pathophysiology Final Exam Questions & Answers-While viewing the electrocardiogram, the nurse recalls the _____ conducts action potentials down the atrioventricular septum. - Bundle of His Which of the following patient would be most prone to metabolic acidosis? A patient with: - Diabetes whose glucoses are uncontrolled A 76-year-old patient had the following arterial blood gas sample after his stomach surgery in which his gastric content and fluid were removed: pH 7.55, PCO2 50,...

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 EXAM PREP | 2024 / 2025 Newly Updated | Questions and Verified Answers | Highly Rated Guide Q: What 4 aspects of a trial should a sponsor focus on when monitoring for compliance per 21 CFR 312.56? Answer: 1) Progress of investigations under IND 2) Secure compliance or discontinue investigators that are not compliant and notify FDA 3) Review safety/effectiveness of drug and report safety issues to FDA + make annual reports or progress 4) Notify FDA, all IRBs and all investigators if drug pr...

ACRP CCRC Exam Questions and Answers | Latest Update 2023/2024 GRADED A+. Audit Report - Answer Written Evaluation - not regularly made available to regulatory body; only when serious evidence exists concerning non-compliance Audit Trail - Answer Documentation of audit events Single Blind Study - Answer Subjects Unaware Double Blind Study - Answer Subjects & Researchers are unaware Comparator - Answer Item used as an active control references in a clinical trail Coordinating Committee - An...

While viewing the electrocardiogram, the nurse recalls the _____ conducts action potentials down the atrioventricular septum. -ANSWER Bundle of His Which of the following patient would be most prone to metabolic acidosis? A patient with: -ANSWER Diabetes whose glucoses are uncontrolled A 76-year-old patient had the following arterial blood gas sample after his stomach surgery in which his gastric content and fluid were removed: pH 7.55, PCO2 50, HCO3 35. What acidbase imbalance is most ...

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

A client reports to the nurse he has not had a BM in 2 days. Which intervention should the nurse implement first? A. instruct caregiver to offer a glass of prune juice B. notify HCP and request script for stool softener C. Assess clients med rec and see normal BM pattern D. Instruct caregiver to increase clients fluids to five 8 ounce glasses per day. correct answer C!! Always assess first. You dont know enough to ask for stool softener A client who has COPD is resting in semi fowlers w/...

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 ...

300 Leadership Questions 1. Vien is receiving oral potassium supplements for his condition. How should the supplements be administered? A. undiluted B. diluted C. on an empty stomach D. at bedtime 2. Normal venous blood pH ranges from: A. 6.8 to 7.2 B. 7.31 to 7.41 C. 7.35 to 7.45 D. 7.0 to 8.0 3. Respiratory regulation of acids and bases involves: A. hydrogen B. hydroxide C. oxygen D. carbon dioxide 4. To determine if a patient’s respiratory system is functioning, the nurse ...