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Study coordinator
Research nurse
Study director
All of the above
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True
False
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Personnel
Equipment
Methods
All of the above
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True
False
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OHRP
Study director
FDA
None of the above
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Current summary of training
Current summary of experience
A job description
All of the above
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True
False
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Study director
Study coordinator
Quality assurance unit
All of the above
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True
False
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True
False
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Advocate
Parent
Witness
None of the above
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Adults
Children
Vulnerable persons
All of the above
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True
False
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Both parents
One parent
A legally authorized representative
All of the above
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The risk is justified by the anticipated benefit
Adequate provisions are made for soliciting the assent of the children and permission of their parents and guardians
The relation of the anticipate benefits to the risk is at least as favorable to the subjects as presented by the alternatives
All of the above
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IRB
Parent
Child
All of the above
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The clinical investigation involves no more than minimal risk
The waiver will adversely affect the rights and welfare of the subjects
The clinical investigation could not practically be carried out without the waiver
All of the above
A and c
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Maturity
Ages
Psychological state of the children involved
All of the above
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True
False
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Parent
Advocate
Guardian
All of the above
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True
False
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Food and Device Administration
Freedom and Drug Association
Food and Drug Administration
Food and Drug Association
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Clinical Research Organization
Food and Drug Administration
Sponsor
Investigator
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True
False
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True
False
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Other information justifying a waiver
A description of alternative submission or course of action
An explanation of why the sponsor's compliance with the requirement is unnecessary or cannot be achieved
All of the above
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Investigation new drug application
Investigational new drug application
Investigator new drug application
Investigational new device application
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New biological drug
New drug
All of the above
None of the above
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Safety
Rights
Well-being
All of the above
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Evaluation of reports
Accrual of subjects
Design of the protocol
Preparation of materials to be submitted to the FDA
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True
False
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15 days
30 days
2 months
1 year
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Phase 1
Phase 2
Phase 3
All of the above
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Phase 1
Phase 2
Phase 3
All of the above
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A description of the observations and measurements to fulfill the study's objectives
A description of the clinical procedures and laboratory procedures
A statement of the objectives and purpose
All of the above
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They include several hundred to several thousand subjects.
They are well controlled.
They are closely monitored.
They usually involve no more than several hundred subjects
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Phase 1
Phase 2
Phase 3
All of the above
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Patients
Animals
Normal volunteer subjects
A and c
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Protocol
Amendment
IND
Waiver
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Two copies
Three copies
Original and two copies
One copy
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The human subject is confronted by a life-threatening situation
Time is not sufficient to obtain consent from the subject's legal representative
Informed consent cannot be obtained from the subject because of an inability to communicate with, or obtain legally effective consent from the subject
All of the above
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True
False
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Division of Defense
Department of Direction
Department of Defense
None of the above
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Secretary of Defense
Vice President
President
All of the above
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True
False
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IRB
Sponsor
Investigator
Department of Defense
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Five
Three
Ten
Seven
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Protocol
Consent form
Written information sheet
None of the above
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President
Secretary of Defense
Department of Defense
None of the above
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Five
Three
Two
One
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