Transcript Good Clinical Practice

EDC
(Electronic Data Capture)
www.amber-cro.com
Daugavas 38/1, Marupes pag, Riga region
LV-2167, Latvia
Company registration number Nr.:4 0003913325
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EDC
(Electronic Data Capture)
An Electronic Data Capture (EDC) system is a
computerized system designed for the collection of
clinical data in electronic format for use mainly in human
clinical trials.
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EDC history
EDC is often cited as having its origins in another class of
software — Remote Data Entry (RDE) that surfaced in
the life sciences market in the late 1980s and early
1990s.
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EDC history cont.
With the rise of the Internet in the mid 1990s, the obvious
solution to some of these issues was the adoption of
web-based software that could be accessed using
existing computers at the investigational sites. EDC
represents this new class of software.
Research using “ paper “ technology
Typical problems
• Data are copied multiple times, which produces errors
• Errors that are generated are not caught until weeks
later
• Visibility into the medical status of patients by sponsors
is delayed
• Great paper work
• Time-consuming process
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Paper CRF
Data
Manager
Project
Manager
CRA
Data base
CRF
Data
entry
Doctor
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CRF
EDC
Data Manager
PM
CRA
Doctor
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Data Base
EDC from AmberCRO
• High data security
• Elastic database structure
• Easy navigation
• Simple data verification system
• Comprehensive report system
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Data Protection
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CRF data uploads to central server on a per page basis
128-bit data encryption
Data stored on server - no data is stored on Site PCs
Customisable access levels
Individual user accounts
Detailed audit trails
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Database structure
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The capability to develop a library of sponsor specific
CRF pages creates efficiencies when processing
multiple projects
Flexible data collection, as well as sponsor defined
naming conventions
Fast new studies implementation
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Navigation
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Different homepages, designed to be simple for site
staff, sponsor and CRAs to use
Easy navigation from one page to another
Easy understand information layout
Screens built to mirror a paper CRF, although can be
customised with different backgrounds, logos, styles
and Data Entry instructions
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Data verification
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Automatic query generation
Data verification on input – abnormal value entered.
Standartised queries
If data is corrected, query is automatic approved as
correct
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Report system
• Real-time project management and monitoring
• Standard metrics combine with our design flexibility to
create any sponsor defined reports
• Clinical data exports can be facilitated in a variety of
formats, such as Excel
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EDC from AmberCRO for YOU
http://www.amber-cro.com/edc
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