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Præsentation
Ålborg Universitet 03-03-2016
Datamanager
Peter Bjødstrup Jensen, Cand. Scient, Phd.
REDCap
• Udviklet ved Vanderbilt University i 2008 som et brugervenligt electronic data capture system til academic investigator-initieret klinisk forskning
• Løbende udvikling af core developer team ved Vanderbilt • Distribueret via REDCap korsortiet som pt. består af omkring 1600
akademiske institutioner i næsten 100 lande. • Mere end 200.000 projekter og 250.000 slutbrugere • OPEN har 3 REDCap installationer hosted af Region Syddanmark IT
Dataindsamling via browseren
Web Server Apache REDCap
Database Server MySQL
HTTPS (internet)
Pro
jekt wo
rkflow
-> Browserbaseret
Genveje
Dataindsamling
REDCap moduler
Hjælp
REDCap Online Designer
REDCap Felttyper
Opsætning af felter
Forgreningslogik
Beting visningen af et felt på værdier af andre felter
Longitudinale studier
Definer projektevents. Rækkefølge og tidsrum
Tilknyt instrumenter/skemaer til definerede events
Studie overblik – Event grid
Studieoverblik - Dashboard
REDCap funktioner
• Surveys • Scheduling & fælles kalender • Randomisering • Double data entry • Logning med komplet audit trail på alle datapunkter • Multiuser & multisite, detaljerede brugerrettigheder (Data Access Groups) • Data import • Simpel dataexport til R, Stata, SPSS, SAS og Excel • Kvalitetskontrol & Data oprensning • Datakommentarer ( Data resolution workflow ) • Generering af rapporter • Udvidelse af funktionalitet via triggers, API, Plugins og hooks • Filupload (både bundet til records/felter og i project repository) • Offline dataindsamling
Aktivitet
Is REDCap 21 CFR Part 11 compliant? REDCap has the features necessary to serve as the database component of a 21 CFR Part 11 compliant study. However, the software must be placed in an environment with servers, security, personnel, policies, procedures, training, validation and documentation meeting the requirements of Part 11 and the predicate rules for the underlying legislation. An FDA auditor will review all of this documentation to determine AT THE PROJECT LEVEL if a study is compliant. The REDCap Part 11 Compliant Project's goal is to develop a REDCap “Compatibility” Module and help created supporting documentation and templates. At best, REDCap can offer an application containing the required technical requirements of a compliant system – the rest is up to the institution.
Terms of use
2.7 Eligible Licensees. This REDCap license is intended to provide access and use of the REDCap Software to not-for-profit (including governmental and military) institutions and non-commercial entities and organizations who aid in the advancement of clinical and translational healthcare research only. In the event that Vanderbilt determines, at any time and in its sole discretion, that a Licensee does not meet its requirements, Vanderbilt shall have the right to terminate this Agreement upon ten (10) days written notice. If the Licensee is in breach of its representations set forth in Sections 6.2 or 6.8 hereinbelow, this Agreement shall be hereby and immediately rendered null, void and without effect.
