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Socra Study

This class was created by Brainscape user Shay Lavon Robison. Visit their profile to learn more about the creator.

By: Shay Lavon Robison
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Decks in this class (14)

Ethics Codes
The nuremburg code,
The belmont report,
Three principles of the belmont r...
11  cards
Vocab
Adverse drug reaction adr,
Adverse event,
Adr vs ae
44  cards
ICH GCP
Before a trial is initiated,
Who approves a protocol,
Who makes medical decisions and g...
47  cards
Who Keeps?
Advertisement for subject recruit...,
Signed agreements between the spo...,
Sample of label s attached toinve...
21  cards
45 CFR 46
What is 45 cfr 46 based on,
What does 45 cfr 46 offer,
What does subpart b cover
23  cards
21 CFR Part 11
Who created 21 cfr part 11,
When is a record considered to be...,
What is 21 cfr 11 applicable to
11  cards
21 CFR Part 50
Who does 21 cfr part 50 apply to,
Why was 21 cfr part 50 created,
What is the definition of assent
17  cards
21 CFR Part 56
What does 21 cfr part 56 cover,
Exemptions from irb requirement,
What information must an irb regi...
32  cards
21 CFR Part 312
What does 21 cfr,
What does 21 cfr 312 exempt,
How should an investigational new...
62  cards
21 CFR Part 812
What does 21 cfr part 812 apply to,
What should be included in an ide...,
Do significant risk sr device stu...
32  cards
Important timelines
If informed consent is not feasib...,
If informed consent is not feasib...,
When does emergency use of a test...
18  cards
CITI questions
Adults with more than a twelve 12...,
Development of most new drugs fro...,
Long term toxicology of an experi...
33  cards
Differences between ICH E6 guidelines and FDA regulations
Differences in obtaining a statem...,
Differences in confidentiality of...,
Differences in investigator respo...
31  cards
Who is responsible?
Who is responsible for monitoring...,
Which party submits the completed...,
Who is required to report promptl...
38  cards

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Socra Study

  • Class purpose General learning

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