Mytrus Confidential (Please Do Not Distribute) 1
Mytrus Confidential (Please Do Not Distribute) 1
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Mytrus Confidential (Please Do Not Distribute).3
Modernizing the consent process has big
advantages for patients, sponsors and sites.
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Patients are the focus of consent
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Q A4
Dr Smith
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Device Distribution and Training
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Handles Versions and Amendments
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Network Storage
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Sponsors Access Consent Data
Sponsor
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Project Teams Can Track ConsentActivity
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• US and International sites • Translations in multiple languages• Partnership with inVentiv Health allows reach in many countries
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ROI Opportunities....
• Much faster recruiting• Consent language learnings• Amendment management• Site management/selection• CRA oversight/remote monitoring• Risk calculations• Better patient retention Sponsor
That’s what I’m talking
about!
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Validation Study Evidence!
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• Randomized trial @ Sutter Hospital in California• Measured recall of study details 24 hours after consent• 58% correct answers in Paper Group vs. 75% in iPad Group
58% 75%p=<.01 !
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Recognition
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Regulatory Support
“We support this novel approach.”“This is precedent setting.”
Reviewed by >30 additional local and academic IRBs
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Regulatory Compliance:
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• IRBs consider eICF signature as synonymous to handwritten signature per 21 CFR Part 11
• Mytrus supports video capture and photo capture of consent where required by emerging regulations
• No PHI stored on devices • All data stored on off-site databases to comply with
HIPAA• Maintain security through mobile device management to
control all settings and physically locate device at all times
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Mytrus Confidential (Please Do Not Distribute).
Demo
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