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Clinical Research Regulations
> 21 CFR 11 > Flashcards
21 CFR 11 Flashcards
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Clinical Research Regulations
(31 decks)
45 CFR 46
The Nuremberg Code - C
The Belmont Report - C
The Declaration of Helsinki - C
21 CFR 11
21 CFR 50
21 CFR 56
21 CFR 312
21 CFR 812
ICH GCP Rev2
ICH GCP Rev3 (not for exam)
ICH E2A
FDA forms
Coordinate the development of initial research study protocol
Create or obtain research study documents
Obtain research study approval from necessary stakeholders
Obtain research study product, related materials, equipment, tools and aids
Select research study sites
Train research study staff members
Evaluate research study's compliance with relevant local, state and provincial laws
Execute Research Strategy
Assure regulatory compliance
Manage research study product
Identify, document & report research study anomalies
Manage subjects Recruit subjects
Maintain the research study
Communicate with research study stakeholders
Perform/participate in a research study audit
Perform/participate in a research study closeout visit
Develop & submit research study closure reports
Archive/retrieve research study records
