Commitment to eConsent success begins at trial planning

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www.prorelixresearch.com How to Integrate eConsent in Trial Planning

Commitment to eConsent success begins at trial planning.

This should be included in site-selection questionnaires, and checklists should be in place to help identify any challenges to eConsent adoption concerning experience, patient population, SOPs, technology, and connectivity. www.prorelixresearch.com

When dealing with potential sites, sponsors should clearly convey that eConsent is the established and expected method for consenting patients, honing into the information to demonstrate how it will benefit them and their patients.

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Optimize informed consent form digitization timelines

Traditionally, the creation of the electronic informed consent form (eICF) would not take place until approval of the paper ICF per country/site was received.

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Optimizing the submission strategy would be a KEY -- in partnership with IRBs and ethics committees by approaching the ICF digitization in parallel with the paper ICF approval process. This approach enables the sponsor to be ready to start consenting patients by the site initiation visit (SIV), a critical rung in the ladder to higher eConsent site adoption.

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When sites are trained and confident to start consenting electronically from the first patient visit, we see them the technology rapidly—bringing on multiple benefits.

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