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GCP
GCP
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annkul
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Question
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szkodliwy, niepożądany
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adverse
niepożądana reakcja na lek
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adverse drug reaction
niekorzystny efekt
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adverse effect
formularz zgłoszenia przypadku (CRF)
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case report form (CRF)
badania kliniczne
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clinical trial
organizacja badawcza kontraktowa (CRO)
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contract research organization (CRO)
dobra praktyka kliniczna (GCP)
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good clinical practice (GCP)
bezstronny świadek
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impartial witness
niezależna komisja etyczna (IEC)
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independent ethics committee (IEC)
świadoma zgoda
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informed consent
inspekcja, przegląd
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inspection
produkt badany
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investigational product
śledczy, badacz
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investigator
broszura badaczy
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investigators brochure
monitorowanie
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monitoring
protokół
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protocol
Zapewnienie jakości
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quality assurance
kontrola jakości
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quality control
organy regulacyjne, odnośnie władzy
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regulatory authorities
poważne zdarzenie niepożądane (SAE)
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serious adverse event (SAE)
poważne niepożądane reakcje na lek (SADR)
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serious adverse drug reactions (SADR)
dane źródłowe
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source data
dokumenty źródłowe
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source documents
współbadacz
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subinvestigator
ośrodek badawczy
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trial site
nieoczekiwane działanie niepożądane leku
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unexpected adverse drug reaction
wrażliwe podmioty/ osoby mogące podlegać naciskom
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vulnerable subjects
dobro uczestnika badania
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well-being of the Trial Subject
Certyfikowana kopia
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certified copy
plan monitorowania
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monitoring plan
walidacja systemów komputerowych
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validation of computerized systems
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