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For A Description of Monitor'sTM Suite
Applications
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The Monitor's SuiteTM
is an integrated, flexible set of database tools
specifically designed for Clinical Research Study
Monitors, Project Managers, and Quality Assurance
Auditors. The system permits easy entry and rapid
retrieval of information with respect to clinical
study sites, subjects, regulatory files, data
quality and test articles. Designed for use on
site or in-house, the system can utilize notebook
and/or desktop computers, to facilitate:
CRF data
audits and their attendant data
corrections.
Creating
an organized inventory of study file
contents to ensure the presence of
required regulatory documents and to help
synchronize file contents at the study
site, monitor and sponsor locations.
Documentation
and calculation of drug accountability
and reconciliation for a wide variety of
parenteral and oral drug formulations
used in both in-patient and outpatient
study settings.
Maintenance
of an up-to-date directory of clinical
study site information.
Generating
Status Reports from a current subject
roster in one or more single or
multi-center studies.
The Monitor's
SuiteTM is an application consisting
of an integrated set of database templates for
FileMaker® Pro for Windows (version 3.0 or
later), and requires the proper installation and
operation of licensed FileMaker® Pro and Windows
95/98 software.
The Monitor's
SuiteTM applications are designed to
aid in managing and monitoring clinical research
studies. These applications are not
designed or validated for the
recording or storage of
clinical research data or other
research data management
purposes, and should not be used
for such. Changes to the content of database
files may
be made freely without the creation of an audit
trail.
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