Either directly or ind - Study guides, Class notes & Summaries
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CITI GCP Training Questions and Answers Graded A+
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CITI GCP Training Questions and Answers Graded A+ 
ICH E6 has broader requirements than FDA or HHS concerning confidentiality of medical records and access by third parties. If investigators are complying with ICH E6 guideline, they must: 
Clearly disclose to subjects in the informed consent form that the monitor, auditor, IRB/IEC, and the regulatory authorities may have access to the subject's medical records. 
 
ICH (2016) E6 Section 4.8.10(n) states that the informed consent should indicate ...
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Good Clinical Practice Test Questions and Answers Latest Updated
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Good Clinical Practice Test Questions and Answers Latest Updated 
Which of the following are the three principles included in the Belmont Report? 
• Respect for Persons 
• Beneficence 
• Justice 
 
 
 
Which of the following is an example of how the Principle of Beneficence can be applied to a study employing human subjects? 
• Determining that the study has maximized benefits and minimized risks. 
 
* The Belmont Report's principle of beneficence includes the two general rules as compl...
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SOCRA - CCRP (high level) Questions and Answers (100% Correct Solutions)
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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 
 ...
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Good Clinical Practice (GCP) Questions And Answers With Verified Solutions
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A 46-year-old man is currently enrolled in a phase III study of a drug for severe diabetic neuropathy. 
While the study is ongoing, a new drug becomes commercially available that may have equal or greater 
benefit to the subject. The investigator should do which of the following? - Discuss the pros and 
cons of both the investigational drug and the commercially available drug and then allow the subject to 
decide whether to withdraw from the research to take the new drug 
A 510(k) Premarket Noti...
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CCRC Exam, ACRP CCRC EXAM PREP, CCRC Exam Prep, ACRP CCRC, *CCRC Study Set
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CCRC Exam, ACRP CCRC EXAM PREP, CCRC Exam Prep, ACRP CCRC, *CCRC Study Set 
 
Clinical Trial 
process of studying human subjects to assess the effect of a particular intervention (Drug, biologic, device, procedure or behavior change) on a pre specified set of measurable events. 
Endpoint or Outcome 
Clinical event, measurable indicator, subject reported response 
Brainpower 
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Feasibility of a Study 
Assessment of resource needs, regulator requirements, and potential level of risk of ha...
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CCRC Exam, ACRP CCRC EXAM PREP, CCRC Exam Prep, ACRP CCRC, *CCRC Study Set
- Exam (elaborations) • 214 pages • 2024
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CCRC Exam, ACRP CCRC EXAM PREP, CCRC Exam Prep, ACRP CCRC, *CCRC Study Set 
 
Clinical Trial 
process of studying human subjects to assess the effect of a particular intervention (Drug, biologic, device, procedure or behavior change) on a pre specified set of measurable events. 
Endpoint or Outcome 
Clinical event, measurable indicator, subject reported response 
Brainpower 
Read More 
Feasibility of a Study 
Assessment of resource needs, regulator requirements, and potential level of risk of ha...
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CITI Good Clinical Practice 60 (US only Drug or Device Research)Exam Q and A| Success Guaranteed|42 Pages |A+
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A 46-year-old man is currently enrolled in a Phase III study of a drug for severe diabetic neuropathy. While the study is ongoing, a new drug becomes commercially available that may have equal or greater benefit to the subject. The investigator should do which of the following? - ️️Discuss the pros and cons of both the investigational drug and the commercially available drug and then allow the subject to decide whether to withdraw from the research to take the new drug. 
A 510(k) Premarket N...
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Test Bank for Rau’s Respiratory Care Pharmacology, 9th Edition By Gardenhire, ISBN-10:0323299687 | Complete All Chapters
- Exam (elaborations) • 245 pages • 2023
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Test Bank for Rau’s Respiratory Care Pharmacology, 9th Edition By Gardenhire, ISBN-10:0323299687 | Complete All Chapters. Which receptor site results in tachycardia, an increased potential for arrhythmias, and an increased 
cardiac output? 
a. Beta 1 receptor c. Alpha receptor 
b. Beta 2 receptor d. Delta receptor 
ANS: A 
Stimulation of the beta-1 receptors results in tachycardia, an increased potential for arrhythmias, and 
an increased cardiac output. In administering drugs to the pulmonary...
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CCRC Exam, ACRP CCRC EXAM PREP, CCRC Exam Prep, ACRP CCRC, *CCRC Study Set
- Exam (elaborations) • 214 pages • 2024
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CCRC Exam, ACRP CCRC EXAM PREP, CCRC Exam Prep, ACRP CCRC, *CCRC Study Set 
 
Clinical Trial 
process of studying human subjects to assess the effect of a particular intervention (Drug, biologic, device, procedure or behavior change) on a pre specified set of measurable events. 
Endpoint or Outcome 
Clinical event, measurable indicator, subject reported response 
Brainpower 
Read More 
Feasibility of a Study 
Assessment of resource needs, regulator requirements, and potential level of risk of ha...
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Katzung & Trevor's Pharmacology: Examination and Board Review
- Exam (elaborations) • 112 pages • 2023
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Katzung & Trevor's Pharmacology: Examination and Board Review 
 
 
INTRODUCTION 
 
 
1.	A 3-year-old is brought to the emergency department having just ingested a large overdose of tolbutamide, an oral antidiabetic drug. Tolbutamide is a weak acid with a pKa 
of 5.3. It is capable of entering most tissues, including the brain. On physical examination, the heart rate is 100/min, blood pressure 90/50 mm Hg, and respiratory rate 20/min. 
Which of the following statements about this case of tolb...
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