This class was created by Brainscape user DrSerene S. Visit their profile to learn more about the creator.
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DrSerene S
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Decks in this class (12)
SOCRA REPORTING TIMELINES
Timeline for sponsor to notify fd...,
Timeline to submit an ind safety ...,
Timeline to submit an ind safety ...
49
cards
SOCRA Ethics: Nuremberg, Helsinki, Belmont”
What is the main principle of the...,
Which belmont report principle fo...,
Which belmont principle deals wit...
15
cards
21 CFR 11
What is socra part 11 primarily c...,
Which agency regulates part 11 co...,
Part 11 requires validation of wh...
32
cards
21 CFR 50
What is the primary purpose of 21...,
Who must obtain informed consent ...,
What are the essential elements o...
15
cards
45 CFR 46
What is the purpose of 45 cfr par...,
Which populations are considered ...,
What is required for informed con...
49
cards
21 CFR 312
What is the purpose of an investi...,
What three types of ind submissio...,
What are the required components ...
23
cards
21 CFR 56
What is the primary purpose of 21...,
Who must review fda regulated res...,
What is the definition of an irb ...
70
cards
IB
Q1 what does ib stand for in clin...,
Q2 what is the purpose of the ib 2,
Q3 who prepares the ib 3
20
cards
21 CFR 812
Q1 what is the purpose of 21 cfr ...,
Q2 who must comply with 21 cfr 812 2,
Q3 what is an ide 3
20
cards
FDA Forms
Blank 1,
Q1 what is da form 482 used for 2,
Q2 what is fda form 483 used for 3
8
cards
Monitor Responsibilities
What is the primary responsibilit...,
What should a monitor do if they ...,
How does a monitor ensure subject...
10
cards
Sponsor Responsibilties
What is the primary responsibilit...,
How does a sponsor select investi...,
What is the sponsor s role in mon...
10
cards
More about
SOCRA CCRP SEP 2025
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