CLINICAL TRIALS UNIT REDCapCloud What it can do for you.

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Presentation transcript:

CLINICAL TRIALS UNIT REDCapCloud What it can do for you

REDCap Cloud Background Based on the well known and used REDCap system build by Vanderbilt. nPhase tasked with validating this free version and making it cloud- ready for business and regulated trial work. Launched 2016 in the US, now available in Europe. Hosted in the EU, complies with GDPR.

Benefits over Coalition version Comes with eLearning system. UI Improvements. Form library (negotiable.) Pre-configured ePRO (not yet mobile.) Fully validated for regulated use (audit ready.) As such, already in use in industry:

Our Setup Free license if an investigator instigated trial, with soft limits: 3 sites, 100 users, no fixed limits on subjects. Regulated or larger trials require license agreement following negotiation with nPhase.

Typical setup steps – Setup CRFs Drag and drop interface. Questions can be moved between sections. Branching logic available. Library of forms can be built up, library available from nPhase upon negotiation.

Typical setup steps – Add fields to CRFs Create Field Types Field Options Min/Max Values Other Options Text Box Yes Medical Coding if enabled in Parameters with option to select from dictionaries enabled Notes Box No   Phone E-mail Number Box (integer) Number Box (decimal) Max Decimal Size Date Box Partial Date Date Time Box Time 12-24 Hour Clock; Default Current Time Calculated Field Calc. Equation: Measurement Units Drop-down Response Sets Radio Buttons Checkboxes Yes – No True – False Signature File Upload Folder Upload Slider Labels (LMR) & Display Number Min / Max Value Descriptive Text Add Image/Link New Section RegEx Regular expressions IFrame HTML insert load options Media Object Insert MP3 Audio/MP4 Video Rich Text Add images and/or video to a field Fields can be added to sections, or pages. Any field can be repeated a fixed or variable number of times, with optional limits. Rules can be set against any field using a logic engine. These can hide/show other fields, CRFs, trigger emails (good for safety reporting.) These can be global across all timepoints or locked down in scope.

Typical setup steps – Add CRFs to events Events can happen once (e.g. Baseline) or repeat a set number of times. They can be scheduled (time delay) or calendared (booked in.) In ePRO, these are used to email invites to participants.

Typical setup steps – ePRO Any CRF can be turned into an ePRO version, in the form of a survey. These can be lightly themed, still quite locked down at the moment. nPhase intend for these to be fully mobile accessible, still working on validating this. Surveys are emailed to the participant to complete based on events.

Still to come… Simple to Complex Randomisation – Not yet validated. API integration – We can integrate with our randomisation system while the above work is completed. Full mobile ePRO – we will be involved in testing.

Other benefits A REDCap Cloud (RCC) UK User Group has just been set up Exeter, Plymouth, Manchester, Hull/York. Full Software Development Lifecycle (SDLC) compliant environment – Build, Test & Live servers (best practice and helps with validation for regulated trials.) Built-in file transfer system – like DropBox/OneDrive but on secure environment Compliance – now (10/2018) ISO27001 compliant!

Any Questions? https://www.redcapcloud.com The system is extremely flexible out of the box, happy to set up demos. Slides will be available after, more info also at: https://www.redcapcloud.com