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Brittany K
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Decks in this class (24)
conflicts of interest
Primary strategies for eliminatin...
1
cards
21 CRF Part 11
21 cfr part 11 covers,
Define a closed system,
Define an open system
11
cards
21 CFR Part 50
What does 21 cfr part 50 cover,
What 3 applications are included ...,
What is a clinical investigation
12
cards
21 CFR part 56
What does 21 cfr part 56 cover,
How many members should an irb have,
Each irb should include
10
cards
21 CFR part 312
What does 21 cfr part 312 cover,
A clinical investigation of a dru...,
Products exempt from part 312 req...
17
cards
FDA forms
482,
483,
1572
7
cards
Belmont report
When was the national research ac...,
What did the national research ac...,
What is the national commission c...
16
cards
Nuremberg code
Ten ethical principles for human ...,
What was the nuremberg code a res...,
Principle 1 what is absolutely es...
19
cards
Misc. 2
What document established the nee...,
Who was the declaration addressed to,
What is significant equity interest
12
cards
ICF Harmonised Guideline for GCP
What is the ich,
Ich harmonised guideline for gcp,
What does gcp cover
18
cards
ICH clinical safety data management
0
cards
investigator roles and responsibilities
0
cards
sponsor's roles and responsibilities
0
cards
IND reporting
0
cards
informed consent
0
cards
IRBs
0
cards
Trial protocol and IB
0
cards
Misc
Does an irb need to register with...,
What is an assurance,
Is an assurance required by the fda
19
cards
Additional
10 principles of nuremberg code
1
cards
21 CFR part 812
Cfr 21 part 812 covers,
What is a significant risk device,
What is a transitional device
10
cards
45 CFR part 46
0
cards
regulations, forms, definitions
21 cfr 11,
21 cfr 50,
21 cfr 5025
33
cards
Cards to study
What is premarket approval pma,
What is wnl,
What are phase 2 studies
67
cards
Cards to study 2
When can informed consent form re...,
Can someone be an advocate for a ...,
Can a ward have both an advocate ...
70
cards
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CCRP
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