Clinical Research Regulations

This class was created by Brainscape user Jana M. Visit their profile to learn more about the creator.

Decks in this class (31)

45 CFR 46
Blank 1
1  cards
The Nuremberg Code - C
What is the purpose of this docum...,
When is human experimentation jus...,
What supersedes the ode to some e...
14  cards
The Belmont Report - 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 - C
What is the purpose of the declar...,
Who developed the declaration of ...,
Who does the declaration apply to 3
17  cards
21 CFR 11
0  cards
21 CFR 50
0  cards
21 CFR 56
0  cards
21 CFR 312
0  cards
21 CFR 812
0  cards
ICH GCP Rev2
0  cards
ICH GCP Rev3 (not for exam)
0  cards
ICH E2A
0  cards
FDA forms
Form 482 1,
Form 483 2,
Form 1572 3
7  cards
Coordinate the development of initial research study protocol
0  cards
Create or obtain research study documents
0  cards
Obtain research study approval from necessary stakeholders
0  cards
Obtain research study product, related materials, equipment, tools and aids
0  cards
Select research study sites
0  cards
Train research study staff members
0  cards
Evaluate research study's compliance with relevant local, state and provincial laws
0  cards
Execute Research Strategy
0  cards
Assure regulatory compliance
0  cards
Manage research study product
0  cards
Identify, document & report research study anomalies
0  cards
Manage subjects Recruit subjects
0  cards
Maintain the research study
0  cards
Communicate with research study stakeholders
0  cards
Perform/participate in a research study audit
0  cards
Perform/participate in a research study closeout visit
0  cards
Develop & submit research study closure reports
0  cards
Archive/retrieve research study records
0  cards

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Clinical Research Regulations

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