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Ashley O’Neil
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Decks in this class (22)
Clinical Safety Data Management
An adverse event is defined as on...,
An adverse event is one which a i...,
A subject in an arthritis clinica...
33
cards
General Considerations for Clinical Trials
The ethical principles underlying...,
The term non clinical studies ref...,
Nonclinical studies a should be p...
36
cards
Statistical Principles in Clinical Trials
The primary concern in a confirma...,
Statistical principles are releva...,
Bias is defined as a error in mis...
54
cards
Clinical Investigation Pediatric Population
The decision to proceed with a pe...,
The decisions to proceed with a p...,
Formulation of pediatric drugs ma...
34
cards
Good Clinical Practice
In ich gcp an audit is defined as...,
In ich gcp an inspection is defin...,
In ich gcp monitoring is defined as
165
cards
IRB Records and Minutes
Irb minutes should record a numbe...,
If a regular voting member and hi...,
The minutes of the irb meeting sh...
11
cards
IRB Membership and Voting
An irb member with a conflict of ...,
When reviewing studies involving ...,
The irb should a have a physician...
10
cards
IRB Decision Making
Actions that the irb can take whe...,
17
cards
Unanticipated Events and SAEs
29
cards
Protocol Deviations
19
cards
DSMB
12
cards
Declaration of Helsinki
7
cards
Belmont Report
10
cards
IND
A 1572 is a contract between a ir...,
15
cards
IDE
18
cards
Financial Disclosures
11
cards
Clinical Trial Design
51
cards
Recruitment
13
cards
Payments
11
cards
Withdrawal of Subjects
9
cards
Situational Analysis
42
cards
Elements of Informed Consent
An essential element of informed ...,
An essential element of consent t...,
The essential basic elements of c...
24
cards
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CCRC
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