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How many days does a sponsor have to report an emergency use of an IP to the FDA? - 5 working days How many members must sit on an IRB? - 5 How long must an IRB retain records per 21 CF R 56? - 3 years after completion of research What are the criteria for IRB approval of research? (7) - 1. Risks to...
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Añadir al carritoHow many days does a sponsor have to report an emergency use of an IP to the FDA? - 5 working days How many members must sit on an IRB? - 5 How long must an IRB retain records per 21 CF R 56? - 3 years after completion of research What are the criteria for IRB approval of research? (7) - 1. Risks to...
Non thermal effects of 20% pulsed ultrasound include what? Correct Answer: a. Facilitation of the inflammatory process (release of histamine) 
b. Increase in cell diffusion and membrane permeability 
c. Help to synthesize the extra-cellular matrix and collagen 
 
Which muscle originates on the scap...
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Añadir al carritoNon thermal effects of 20% pulsed ultrasound include what? Correct Answer: a. Facilitation of the inflammatory process (release of histamine) 
b. Increase in cell diffusion and membrane permeability 
c. Help to synthesize the extra-cellular matrix and collagen 
 
Which muscle originates on the scap...
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Timeline of Historical Events Correct Answer: Nuremberg Code 1947, Declaration of Helsinki 1964, Belmont Report 1979 
 
The Three Principles of the Belmont Report Correct Answer: respect for persons, beneficence, justice 
 
Application of Respect for Persons Correct Answer: informed consent (auto...
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Añadir al carritoTimeline of Historical Events Correct Answer: Nuremberg Code 1947, Declaration of Helsinki 1964, Belmont Report 1979 
 
The Three Principles of the Belmont Report Correct Answer: respect for persons, beneficence, justice 
 
Application of Respect for Persons Correct Answer: informed consent (auto...
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When isn't an IND application needed? Correct Answer: IND Application is not needed if investigation does not support change in labeling 
 
What information must the general IND include? (21 CFR Part 312.23) Correct Answer: FDA Form 1571: 
-FDA Form 1571 cover sheet 
-Table of contents 
-Investig...
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Añadir al carritoWhen isn't an IND application needed? Correct Answer: IND Application is not needed if investigation does not support change in labeling 
 
What information must the general IND include? (21 CFR Part 312.23) Correct Answer: FDA Form 1571: 
-FDA Form 1571 cover sheet 
-Table of contents 
-Investig...
Prior to archiving a study, documentation of IP destruction at the site should be filed in the study files of the: Correct Answer: PI and Sponsor. 
 
In the case of an incapacitated subject, who should receive a copy of the signed and dated ICF? Correct Answer: The subject's legally acceptable re...
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Añadir al carritoPrior to archiving a study, documentation of IP destruction at the site should be filed in the study files of the: Correct Answer: PI and Sponsor. 
 
In the case of an incapacitated subject, who should receive a copy of the signed and dated ICF? Correct Answer: The subject's legally acceptable re...
Who was tried in the Nuremburg Military Tribunals and why? Correct Answer: Doctors who committed war crimes against humanity including medical experiments on concentration camp inmates and other human subjects without consent 
 
What was the outcome of the Nuremburg Military Tribunals? Correct Answ...
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Añadir al carritoWho was tried in the Nuremburg Military Tribunals and why? Correct Answer: Doctors who committed war crimes against humanity including medical experiments on concentration camp inmates and other human subjects without consent 
 
What was the outcome of the Nuremburg Military Tribunals? Correct Answ...
Nuremberg Code (1947) Correct Answer: 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 Correct Answer: 1. voluntary 
2. necessary for results 
3. logical ...
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Añadir al carritoNuremberg Code (1947) Correct Answer: 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 Correct Answer: 1. voluntary 
2. necessary for results 
3. logical ...
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5 Correct Answer: The minimum number of IRB members 
 
Subjects cannot be enrolled until IRB/IEC approval has been obtained Correct Answer: In a non-emergency situation, under which of the following conditions, if any, may subjects be enrolled into a study prior to IRB/IEC approval? 
 
The Sponsor...
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Añadir al carrito5 Correct Answer: The minimum number of IRB members 
 
Subjects cannot be enrolled until IRB/IEC approval has been obtained Correct Answer: In a non-emergency situation, under which of the following conditions, if any, may subjects be enrolled into a study prior to IRB/IEC approval? 
 
The Sponsor...
What influences a persons metabolic rate? Correct Answer: Exercise, gender, genetics, age 
 
Which is the macronutrient that provides more than twice as many calories as the other two Correct Answer: Fat 
 
Foods that raise insulin levels have... Correct Answer: added sugar 
 
When feeling stress...
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Añadir al carritoWhat influences a persons metabolic rate? Correct Answer: Exercise, gender, genetics, age 
 
Which is the macronutrient that provides more than twice as many calories as the other two Correct Answer: Fat 
 
Foods that raise insulin levels have... Correct Answer: added sugar 
 
When feeling stress...
How long is the reporting period for equity interest and significant payments? Correct Answer: study period plus one year 
 
Pre-Study Documents (Essential Documents) Correct Answer: FDA 1572 (drug) or signed investigators agreement (devices) CVs, licenses, ect 
Fully executed contract and budget ...
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Añadir al carritoHow long is the reporting period for equity interest and significant payments? Correct Answer: study period plus one year 
 
Pre-Study Documents (Essential Documents) Correct Answer: FDA 1572 (drug) or signed investigators agreement (devices) CVs, licenses, ect 
Fully executed contract and budget ...
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How are lipids carried Correct Answer: on lipoproteins in the blood because they are insoluble in water 
 
Proteins found on lipoproteins Correct Answer: apolipoproteins 
 
Density of lipoprotein with less lipid and greater protein Correct Answer: more dense 
 
Density of lipoprotein with more li...
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Añadir al carritoHow are lipids carried Correct Answer: on lipoproteins in the blood because they are insoluble in water 
 
Proteins found on lipoproteins Correct Answer: apolipoproteins 
 
Density of lipoprotein with less lipid and greater protein Correct Answer: more dense 
 
Density of lipoprotein with more li...
Assessment Correct Answer: an objective evaluation or 
appraisal of an individual's health status, 
including acute and chronic conditions 
 
How does an assessment gather information? Correct Answer: through collection of data, observation, and physical examination 
 
What type of assessment? 
 ...
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Añadir al carritoAssessment Correct Answer: an objective evaluation or 
appraisal of an individual's health status, 
including acute and chronic conditions 
 
How does an assessment gather information? Correct Answer: through collection of data, observation, and physical examination 
 
What type of assessment? 
 ...
programs have been reported to have hypertension Forty-eight 
 
Hypertensive heart disease can lead to left 
ventricular hypertrophy, LV systolic dysfunction, 
atherosclerotic coronary artery disease, aortic 
aneurysm and dissection, and sudden death. 
 
Reportedly 95% of adults with high bloo...
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Añadir al carritoprograms have been reported to have hypertension Forty-eight 
 
Hypertensive heart disease can lead to left 
ventricular hypertrophy, LV systolic dysfunction, 
atherosclerotic coronary artery disease, aortic 
aneurysm and dissection, and sudden death. 
 
Reportedly 95% of adults with high bloo...
Relative Contraindications to exercise training 2nd or 3rd degree block 
A-fib with uncontrolled ventricular rate 
Tachy or brady- arrhythmia 
Electrolyte abnormalities 
SBP>200/DBP>100 
Chronic infection (HIV) 
Hypertrophic cardiomyopathy 
Uncontrolled metabolic disease 
 
Absolute Contrai...
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Añadir al carritoRelative Contraindications to exercise training 2nd or 3rd degree block 
A-fib with uncontrolled ventricular rate 
Tachy or brady- arrhythmia 
Electrolyte abnormalities 
SBP>200/DBP>100 
Chronic infection (HIV) 
Hypertrophic cardiomyopathy 
Uncontrolled metabolic disease 
 
Absolute Contrai...
How are lipids carried on lipoproteins in the blood because they are insoluble in water 
 
Proteins found on lipoproteins apolipoproteins 
 
Density of lipoprotein with less lipid and greater protein more dense 
 
Density of lipoprotein with more lipids and less protein less dense 
 
Maj...
Vista previa 4 fuera de 68 páginas
Añadir al carritoHow are lipids carried on lipoproteins in the blood because they are insoluble in water 
 
Proteins found on lipoproteins apolipoproteins 
 
Density of lipoprotein with less lipid and greater protein more dense 
 
Density of lipoprotein with more lipids and less protein less dense 
 
Maj...
What influences a persons metabolic rate? Exercise, gender, genetics, age 
 
Which is the macronutrient that provides more than twice as many calories as the other two Fat 
 
Foods that raise insulin levels have... added sugar 
 
When feeling stressed, you may feel relief after eating a pie...
Vista previa 2 fuera de 5 páginas
Añadir al carritoWhat influences a persons metabolic rate? Exercise, gender, genetics, age 
 
Which is the macronutrient that provides more than twice as many calories as the other two Fat 
 
Foods that raise insulin levels have... added sugar 
 
When feeling stressed, you may feel relief after eating a pie...
What resources do I need to develop a budget? correct answer: 1. Schedule of Assessments 
2. Institutional Fees 
3. Evaluation and Procedure Charges 
4. Staff Allocation with Hourly Rates 
 
Indirect Cost Rate (IDC) correct answer: All procedural and non-procedural line items. Exemptions: subject ...
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Añadir al carritoWhat resources do I need to develop a budget? correct answer: 1. Schedule of Assessments 
2. Institutional Fees 
3. Evaluation and Procedure Charges 
4. Staff Allocation with Hourly Rates 
 
Indirect Cost Rate (IDC) correct answer: All procedural and non-procedural line items. Exemptions: subject ...
Research correct answer: The systematic study of materials and sources in order to establish facts and reach new conclusions. 
 
Ethical correct answer: Conforming to an established set of principles or accepted professional standards of conduct. 
 
Budget development correct answer: The process ...
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Añadir al carritoResearch correct answer: The systematic study of materials and sources in order to establish facts and reach new conclusions. 
 
Ethical correct answer: Conforming to an established set of principles or accepted professional standards of conduct. 
 
Budget development correct answer: The process ...
ADR correct answer: Adverse Drug Reaction _ relationship between IP and AE is at least reasonably possible 
life threatening ADR reported to reg agencies within 7 days. 
 
Unexpected Adverse drug Reaction correct answer: Severity not consistent with IP information 
Serious UAE (non life threateni...
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Añadir al carritoADR correct answer: Adverse Drug Reaction _ relationship between IP and AE is at least reasonably possible 
life threatening ADR reported to reg agencies within 7 days. 
 
Unexpected Adverse drug Reaction correct answer: Severity not consistent with IP information 
Serious UAE (non life threateni...
coordinating clinical research practice exam| 50 QUESTIONS| WITH COMPLETE SOLUTIONS
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Añadir al carritocoordinating clinical research practice exam| 50 QUESTIONS| WITH COMPLETE SOLUTIONS
what is clinical research? (LECTURE 1) 
 
Research conducted in ______ subjects for the purpose of obtaining medical information correct answer: human 
 
who are the players in clinical research? (5) correct answer: the subject 
 
the clinical research coordinator (CRC) 
 
the principal investiga...
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Añadir al carritowhat is clinical research? (LECTURE 1) 
 
Research conducted in ______ subjects for the purpose of obtaining medical information correct answer: human 
 
who are the players in clinical research? (5) correct answer: the subject 
 
the clinical research coordinator (CRC) 
 
the principal investiga...
Which of the following should be used to determine the extent and nature of monitoring? 
	 
A. Purpose, drug type, and number of subjects 
B. Purpose, complexity, and endpoints of study 
C. Number of subjects, complexity, and length of study 
D. Complexity, drug type, and endpoints of study correct ...
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Añadir al carritoWhich of the following should be used to determine the extent and nature of monitoring? 
	 
A. Purpose, drug type, and number of subjects 
B. Purpose, complexity, and endpoints of study 
C. Number of subjects, complexity, and length of study 
D. Complexity, drug type, and endpoints of study correct ...
Research Exam 3 2023 (Clinical Research Final) questions with complete solutions
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Añadir al carritoResearch Exam 3 2023 (Clinical Research Final) questions with complete solutions
Clinical Research questions with complete solutions
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Añadir al carritoClinical Research questions with complete solutions
ultimate purpose of a profession is to develop a _______________ ______________ that will maximize the effectiveness of practice correct answer: knowledge base 
 
clinical research is a correct answer: structured process of investigating facts and theories and exploring connections 
 
2 requiremen...
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Añadir al carritoultimate purpose of a profession is to develop a _______________ ______________ that will maximize the effectiveness of practice correct answer: knowledge base 
 
clinical research is a correct answer: structured process of investigating facts and theories and exploring connections 
 
2 requiremen...
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