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Decks in this class (14)
Ethics Codes
The nuremburg code 1,
The belmont report 2,
Three principles of the belmont r...
11
cards
Vocab
Adverse drug reaction adr 1,
Adverse event 2,
Adr vs ae 3
44
cards
ICH GCP
Before a trial is initiated 1,
Who approves a protocol 2,
Who makes medical decisions and g...
47
cards
Who Keeps?
Advertisement for subject recruit...,
Signed agreements between the spo...,
Sample of label s attached to 3
21
cards
45 CFR 46
What is 45 cfr 46 based on 1,
What does 45 cfr 46 offer 2,
What does 45 cfr 46 subpart b cov...
23
cards
21 CFR Part 11
What does 21 cfr part 11 offer 1,
When is a record considered to be...,
What is 21 cfr 11 applicable to 3
11
cards
21 CFR Part 50
Who does 21 cfr part 50 apply to 1,
Why was 21 cfr part 50 created 2,
What is the definition of assent 3
17
cards
21 CFR Part 56
What does 21 cfr part 56 cover 1,
Exemptions from irb requirement 2,
What information must an irb regi...
32
cards
21 CFR Part 312
What does 21 cfr 312 apply to 1,
What conditions must be met under...,
How should an investigational new...
62
cards
21 CFR Part 812
What does 21 cfr part 812 apply to 1,
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
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