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CCRP
> ICH clinical safety data management > Flashcards
ICH clinical safety data management Flashcards
Study These Flashcards
CCRP
(24 decks)
conflicts of interest
21 CRF Part 11
21 CFR Part 50
21 CFR part 56
21 CFR part 312
FDA forms
Belmont report
Nuremberg code
Misc. 2
ICF Harmonised Guideline for GCP
ICH clinical safety data management
investigator roles and responsibilities
sponsor's roles and responsibilities
IND reporting
informed consent
IRBs
Trial protocol and IB
Misc
Additional
21 CFR part 812
45 CFR part 46
regulations, forms, definitions
Cards to study
Cards to study 2
