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Comparison of EDC Systems
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This spreadsheet is intended as a brief comparison of low-cost EDC systems currently available. All of the systems included are primarily web-based, and available either free or at low cost suitable for a non-commercial Clinical Trials Unit.
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I have filled in some details on REDCap, the system I am most familiar with. Please add more details, and feel free to add extra categories or features that I have overlooked. Thanks!
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Antony colles 6-Nov-2015
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FeaturesSystem
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REDCapOpenClinicaMacro
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OverviewCostFreeFree for core components, with paid add-ons for randomisation, ePRO, Medical coding etc..
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Licensing- are there any restrictions to use?For non-profit use only. May not be modified or re-sold. Open Source (https://www.openclinica.com/index.php?q=gnu-lgpl-open-source-license)
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Technical RequirementsApache, PHP, MySQL.Apache, Java, Postgresql
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Hosted solution availableNo YesYes
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DeveloperVanderbilt UniversityOpenClinica LLP
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Websitehttp://projectredcap.org/https://www.openclinica.com
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Pros:Free, very easy to set-up and use. Active and helpful Developer community and user forum. Easily extensible via php Plugins and hooks.Free version available. Easy to install and set up straightforward study even for non-technical users. Infinitely customisable if you have the skills.
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Cons:Currently has limited email notification functionality, eg can't send email on randomisation of a patient. However, community developed plugins are available to add this functionality.Some useful tools only in paid-for version. Rubbish reporting! Inflexible user roles. CRF design limitations.
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User managementAuthenticationChoice of Table-based, LDAP, OAuth or combination of these
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AuthorisationDefine roles and permissions, and specify Data Access Groups for study sitesAccess to different 'modules' dependent on (non-customisable) user role. User must be assigned to study/study site to access data.
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ProcessAdministrator adds users. Automated emails are sent with login links. User specifies own password and sets up security questions for if they need to reset their password. Trial Managers can add users to studies and set roles and Data Access groups. Expiration dates can be set for users and studies. Admin dashboard provides a good overview of all system users and their activity.Administrator creates user accounts. Login details emailed automatically or displayed on screen. User specifies own password. Data manager or study director can add users to studies and set roles.
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Study DesignMulti-site support?YesYes
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Longtitudinal StudiesYesYes
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Observational StudiesYesYes
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RCTsYesCan assign subject to study group, but can't differentiate CRF versions or visit schedule by group.
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RandomisationYes, using uploaded Allocation list. Minimisation not built in, but could be added via a plug-in.Not natively supported
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eCRF DesignOnline eCRF designer?YesCRFs designed and items specified in Excel template file offline
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Upload Data Dictionary SpreadsheetYes
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Question typesText, Number, Date, Dropdown, Radio Buttons, Checkboxes, Multi-select, image, file upload, sliderText, Number, Date, Dropdown, Radio Buttons, Checkboxes, Multi-select, image, file upload
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Data ValidationValidates Dates, numbers, integers and decimals, ZIP Codes, phone numbersIn-field number validation and regular expressions specified in CRF template. Cross-field or cross-form validation written as separate XML rule file and uploaded (or GUI rule designer in Enterprise edition)
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Custom ValidationYou can write your own RegEx validation rules and add to the database
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Branching logic (conditionally show/hide questionsYesSimple show/hide logic. Cannot handle complex branching CRFs.
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custom form layoutlimited, but improving. Plugin available to create grid layouts. Native CRF design limited. HTML/Javascript can be inserted into CRF template to modify.
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Online CRF LibraryYesYes (very limited)
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Size of online library~300 CRFs~ 20 CRFs
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Data EntryMethodsVia Web interface or offline mobile App (Android and iOS)
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Double Data Entry?Yes
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Quality Management FeaturesAudit TrailYesYes
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Query HandlingFull query resolution workflow. Queries can be raised on the data entry page, and directed to specific users. Users can reply. entire comment history saved in database. Alternatively users can be given permission to comment on data items, and comments and replies can be displayed on page next to data itemAll users can create annotations and raise queries on data items. Queries can be assigned to another user for action. Queries searchable, and viewable within CRF. Query reporting very poor.
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Data Management FeaturesReportingBuilt in graphs, summaries and basic stats. Customisable downloadable reportsVery limited in GUI. Can create custom datasets for export.
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Data ImportYes, can import data in csv format via built-in date import tool. Can also pull in data from web services using 'Dynamic data pull' moduleYes, via SOAP or REST WebServices or uploading data formatted in CDISC ODM XML
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Data ExportAutomatic via Web interface. Data and metadata can also be exported and imported from the project via an web service API. Permission to do this is controlled on a project and user level by the administrator.Via web interface or DataMart
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Export formatsSAS, STATA, SPSS, R, CDISC ODM XML, CSV
CSV, Excel, SPSS, CDISC ODM XML, DataMart pSQL data dump (Enterprise only)
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Data controlLocking and Database FreezeCRF sign-off, Database lock.
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Other featuresePROOnline web forms and surveysEnterprise only
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automated email invitiations and mailing listyesYes
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SchedulingYesYes
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Medical coding supportYes- can access a variety of medical ontologies provided by BioPortal.Not natively
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Coding Dictionaries availableNot natively
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Offline data collection on mobile devicesYesNot natively
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Customisation and ExtensibilityAdd Study logo to Questionnaires. Program extra functionality using PHP 'hooks', Plugins and external modules. Recently added an 'External module repository- like an 'App store' of extra functionality developed by the community that can be simply downloaded and added to selected projects.Open source - limited by your programming ability
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MonitoringSupports Double Data Entry, comparison between records. Monitors can raise queries on data and view graphs of progress in resolving these. Monitors can be given permission to lock records once data review is complete. A 'Lock with e-signature' option id available allowing certain users to electronically sign an eCRF to confirm it has been monitoredRead-only 'Monitor' user role can raise/respond to queries and mark individual CRFs or entire subject's casebooks as SDV performed.
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