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Jessica Torres
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Decks in this class (11)
Session 1
For emergency consent a family me...,
What is the definition of a legal...,
An informed consent document may ...
20
cards
Session 2
According to ich gcp which docume...,
What is the approximate number of...,
An ind becomes effective if the f...
21
cards
Session 3
Electronic records cannot be used...,
Computer systems including hardwa...,
Electronic signatures are current...
16
cards
Session 4
Significant risk device is define...,
A purpose of monitoring clinical ...,
The initial drug dose is 110mg m2...
20
cards
Session 5 (pop quizzes)
What year was the nuremburg code ...,
What event led to the national re...,
What was developed by the wma in ...
33
cards
21 CFR 11
T f electronic signatures are cur...,
T f if electronic records meet th...,
T f electronic records cannot be ...
35
cards
21 CFR 56
What is the fda s intention of ha...,
The fda s irb regulations apply t...,
T f in the fda s irb regulations ...
60
cards
45 CFR 46
What types of human drug research...,
Direct or indirect identification...,
Research involving the collection...
63
cards
21 CFR 50
To which five classes of product ...,
With respect to 21 cfr 50 the def...,
What is the definition of investi...
61
cards
21 CFR 312
Ind regulations typically do not ...,
Some clinical investigations invo...,
Clinical research on blood groupi...
168
cards
ICH E6 GCP
For what is adr an acronym 1,
Define adverse drug reaction 2,
To be classified as an adr a caus...
66
cards
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Socra
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