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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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Demo

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