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Decks in this class (18)
The Nuremberg Code (Oct 1946 - April 1949) - C
What is the purpose of the nuremb...,
When is human experimentation jus...,
What supersedes the ode to some e...
14
cards
The Belmont Report 1979- C
What is the purpose of the belmon...,
Who wrote the belmont report 2,
What did the commission consider ...
37
cards
The Declaration of Helsinki 1964 - C
What is the purpose of the declar...,
Who developed the declaration of ...,
Who does the declaration apply to 3
17
cards
45 CFR 46 (Protection of Human Subjects - Common Rule) - C
Application of the policy 1,
Sections of 45 cfr 46 2,
Clinical trial 3
51
cards
21 CFR 11 (Electronic records)
21 cfr 11 scope 1,
Compliance with 21 cfr 11 2,
21 cfr 11 does not apply to 3
9
cards
21 CFR 50 (Protection of Human Subjects, ICF)
Blank 1
1
cards
21 CFR 54 (Financial Disclosure)
What are the reasons for potentia...,
What does the applicant need to s...,
What is the form 3454 3
5
cards
21 CFR 56 (IRB) - C
Scope intention 1,
Contents composition operation re...,
Clinical investigation 3
29
cards
21 CFR 312 (IND)
Ind 1
1
cards
21 CFR 812 (IDE)
Blank 1
1
cards
ICH GCP Rev2
Blank 1
1
cards
ICH GCP Rev3 (on exam from 1/1/2026)
Blank 1
1
cards
ICH E2A (Clinical Data Safety Management, AEs)
Adverse event or adverse experien...,
Adverse drug reaction adr 2,
Unexpected adverse drug reaction 3
7
cards
FDA forms
Form 482 1,
Form 483 2,
Form 1572 3
7
cards
Audits and inspections of clinical trials
Blank 1,
Definition of audit 2,
Definition of monitoring 3
6
cards
Definitions
Clinical trial 1,
Clinical investigation 2,
Federal department or agency 3
13
cards
Timelines
Irb continuing review 1,
Reporting of suspension terminati...,
Irb records retention 3
29
cards
FDA vs ICH
0
cards
More about
Clinical Research Regulations
- Company name Unspecified
- Training purpose Unspecified
- Industry Unspecified
- Number of employees who could use this Unspecified
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