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By:
Eric Nguyen
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Decks in this class (16)
21 CFR Part 11
What does 21 cfr part 11 cover,
What is a closed system,
What is an open system
14
cards
21 CFR Part 50
What does 21 cfr part 50 cover,
Clinical investigation means,
Investigator
35
cards
21 CFR Part 56
What does 21 cfr part 56 cover,
Each irb should have at least how...,
Each irb shall include
31
cards
21 CFR Part 312
What does 21 cfr part 312 cover,
Clinical investigation of a drug ...,
What products are exempt from req...
40
cards
21 CFR Part 812
What is cfr 21 part 812,
What is a significant risk device,
What is a transitional device
28
cards
45 CFR Part 46
What does 45 cfr part 46 cover,
Dead fetus,
Fetus
57
cards
FDA Forms
Fda form 482,
Fda form 483,
Fda form 1572
10
cards
The Belmont Report
Which act was signed in to law in...,
The national research act created...,
What is the national commission f...
16
cards
The Nuremberg Code
What is the nuremberg code,
Ethical principle 1 _______ is ab...,
Ethical principle 2 the experimen...
21
cards
Declaration of Helsinki
What is the world medical associa...,
Who is the wma declaration of hel...,
What topics does the declaration ...
7
cards
ICH Harmonized Guideline for Good Clinical Practice (E6)
What is the ich,
Ich harmonised guideline for good...,
What does gcp cover
30
cards
ICH Clinical Safety Data Management
Adverse event experience,
Adverse drug reaction pre approval,
Adverse drug reaction marketed me...
15
cards
Investigator roles and responsibilities
What are the required qualificati...,
All trial related medical or dent...,
True or false the investigator an...
25
cards
Sponsor's roles and responsibilities
If sponsor obligations are assume...,
Before permitting an investigator...,
What are the important components...
27
cards
Conflicts of Interest
Primary strategies for eliminatin...
1
cards
LMR
If an investigator uses the test ...,
How is the prospect of direct ben...,
What are examples of additional p...
131
cards
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SOCRA 2023
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