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Dylan drum
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Decks in this class (17)
45 CRF 46
45 cfr 46 is often referred to as,
These regulations apply to resear...,
Department or agency heads retain...
37
cards
21 CFR 11
What is 21 cfr part 56,
What is the primary role of an in...,
Who is responsible for establishi...
26
cards
21 CFR 50
What is 21 cfr part 50,
Who is responsible for obtaining ...,
What is the primary purpose of in...
31
cards
21 CFR 56
What is 21 cfr part 56,
What is the primary role of an in...,
Who is responsible for establishi...
31
cards
21 CFR 312
What is 21 cfr part 312,
Who is responsible for submitting...,
What information must be included...
26
cards
21 CFR 812
What is the title of 21 cfr part 812,
What is the purpose of 21 cfr par...,
Who is responsible for compliance...
14
cards
FDA Form 1572
What is fda form 1572,
Who completes fda form 1572,
What information does fda form 15...
10
cards
FDA Form 3454 & 3455
What is fda form 3454,
Why is financial disclosure impor...,
Who is required to submit fda for...
21
cards
FDA Medwatch (3500&3500A)
What is fda form 3500,
What agency is responsible for re...,
When should fda form 3500 be used...
11
cards
ICH GCP E6(R2)
Front what does ich stand for in ...,
What is the purpose of ich gcp e6 r2,
Explain the concept of risk based...
40
cards
Nuremburg Code
What is the nuremberg code,
What is the nuremberg code,
Explain the principle of voluntar...
10
cards
Belmont Report
What is the belmont report,
What are the three core principle...,
Explain respect for persons as a ...
18
cards
Declaration Of Helsinki
What is the declaration of helsinki,
When was the declaration of helsi...,
Who developed the declaration of ...
18
cards
Research Study Start-Up
What is research study start up,
List key components of the resear...,
Explain the importance of protoco...
17
cards
Rsearch Study Implementation
0
cards
Research Study Closure
0
cards
Sponsor Roles & Responsibilities
What does 21 cfr 312 state are th...,
What are a sponsor s general resp...,
What responsibilities may the spo...
27
cards
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SOCRA CCRP EXAM
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