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How to Integrate eConsent in 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
Commitment to eConsent success
begins at trial planning.
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.
www.prorelixresearch.com
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.




Optimize informed consent form
digitization timelines
www.prorelixresearch.com
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.
www.prorelixresearch.com
When sites are trained and confident to start consenting
electronically from the first patient visit, we see them
embrace the technology rapidly—bringing on multiple
benefits.
ProRelix Research
is here for the
timely execution
of your projects!
www.prorelixresearch.com

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Integrate eConsent PR-03_03 August.pdf

  • 1. www.prorelixresearch.com How to Integrate eConsent in Trial Planning
  • 2. 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 Commitment to eConsent success begins at trial planning.
  • 3. 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.
  • 4. www.prorelixresearch.com 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. Optimize informed consent form digitization timelines
  • 5. www.prorelixresearch.com 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.
  • 6. www.prorelixresearch.com When sites are trained and confident to start consenting electronically from the first patient visit, we see them embrace the technology rapidly—bringing on multiple benefits.
  • 7. ProRelix Research is here for the timely execution of your projects! www.prorelixresearch.com