pytania na rozmowe Flashcards

1
Q

czym się zajmuje data management

A

process of gathering capturing monitoring analysing and reporting the data

proces pozyskiwania analizy i raportowania danych

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2
Q

jakie są cechy dobrze zebranych danyh

A

valid auditable accurate. easy to replicate and measuring the intended variables

ważne audytowalne dokładne. powtarzalne i łatwe do mierzenia wybranych zmiennych

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3
Q

dwa najważniejsze dokumenty

A

data management plan and case report form

plan zarządzania danymi i karta obserwacji klinicznej

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4
Q

cele CDM / objectives of CDM

A

ensure that the study database is accurate representation of what took place in the study and is sufficiently clean to support the statistical analysis and its interpretation

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5
Q

czym jest data management plan, jakie są jego elementy

A

database structures, procedures for testing validation data entry edit checks, queries and resolution, outlines the roles and responsibilities of staff

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6
Q

CRF do czego

A

to obtain accurate and complete data

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7
Q

edm electronic data management system

A

enables audit trial

is sufficiently secure

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8
Q

elementy robust audit system

A

capture/check
query
amended

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9
Q

kiedy następuje zamknięcie

A

data chasing
validation
cleaning
locking

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