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 Interpretation
of data using statistics, depends firstly on the quality of the collection
process, that is to say, on their correct validation, and secondly on the
transformation of clinical information to electronic data, meaning
re-transcription (from source data to CRF and from CRF to Data Base)
3Es
can manage, totally or partially in collaboration with the promoter, procedure
set-ups for collection, data entry (simple or double), and data validation for
later analysis.
When using INES, data is collected at the source via Internet by direct data
entry using the e-CRF by the Investigator or Study Nurse.
The
quality of data is improved by immediate checks for coherence and illogical or
discordant values during collection. DCFs (queries) are immediately available
on line for Investigators and CRAs. This new technology using INES allows
simultaneous monitoring and data management of studies.
This
optimised organisation using INES is demonstrated by a Work Flow which not only
improves the quality of data but also makes study management charts immediately
available.
The
availability of validated data makes intermediary analysis possible allowing
rapid decision making concerning the continuation or stopping of studies.
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