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Kaitlin K
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Decks in this class (12)
21 CFR Part 11
What does 21 crf part 11 cover,
What is a closed system,
What is an open system
12
cards
21 CFR Part 50
What does 21 cfr part 50 cover,
What is a clinical investigation,
What is an investigator
18
cards
21 CFR Part 56
What does 21 cfr part 56 cover,
Each irb shall have at least how ...,
An irb shall include
11
cards
21 CFR Part 312
What does 21 cfr part 312 cover,
What are the fdas 2 primary objec...,
What are the contents of an ind
33
cards
21 CFR Part 812
What does 21 cfr part 812 cover,
An approved ide permits a device ...,
What is an implant according to 2...
17
cards
45 CFR Part 46
What does 45 cfr part 46 cover,
What is a legally authorized repr...,
What is covered under subpart b o...
18
cards
FDA Forms
What is form 482,
What is form 483,
What is form 1572
7
cards
Belmont Report
What is the belmont report,
Who created the belmont report,
When was the belmont report created
18
cards
Nuremberg Code
What is the nuremberg code,
When was the nuremberg code devel...,
How did the nuremberg code come t...
13
cards
Declaration of Helsinki
What is the declaration of helsinki,
When was the declaration original...,
What organization developed the d...
8
cards
ICH GCP E6 (R2)
What is good clinical practice,
What does compliance with gcp assure,
Gcp applies to all participants i...
26
cards
ICH Clinical Safety & Data Management (E2A)
What s the purpose of the e2a gui...,
Is there currently standard inter...,
In addition to serious unexpected...
6
cards
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SOCRA CCRP Exam
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