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SOCRA 2020

This class was created by Brainscape user Julianna Maccarone. Visit their profile to learn more about the creator.

By: Julianna Maccarone
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Decks in this class (12)

21 CFR Part 11
What does 21 cfr part 11 cover,
What is a closed system,
What is an open system
20  cards
21 CFR Part 50
What does 21 cfr part 50 cover,
What three applications are inclu...,
Clinical investigation means
24  cards
21 CFR Part 56
What does 21 cfr part 56 cover,
Each irb should have at least how...,
Each irb shall include
29  cards
21 CFR Part 312
What does 21 cfr part 312 cover,
Clinical investigation of a drug ...,
What products are exempt from req...
66  cards
21 CFR Part 812
What is cfr 21 part 812,
What is cfr 21 part 812 subpart b,
What is cfr 21 part 812 subpart c
15  cards
45 CFR Part 46
What does 45 cfr part 46 cover,
What does 45 cfr part 46 subpart ...,
What does 45 cfr part 46 subpart ...
20  cards
FDA Forms
Fda form 482,
Fda form 483,
Fda form 1572
7  cards
The Belmont Report
Which act was signed in to law in...,
The national research act,
What is the national commission f...
16  cards
The Nuremberg Code
What is the nuremberg code,
Name the 10 ethical principles fo...,
1 voluntary consent is absolutely...
21  cards
Declaration of Helsinki
What is the world medical associa...,
Who is the wma declaration of hel...,
What topics does the doh address
4  cards
ICH Harmonised Guideline for Good Clinical Practice
What is the ich,
Ich harmonised guideline for good...,
What does gcp cover
18  cards
ICH Clinical Safety Data Management
Adverse event or adverse experience,
Adverse drug reaction adr definit...,
Adverse drug reaction adr definit...
7  cards

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SOCRA 2020

  • Class purpose General learning

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