SlideShare a Scribd company logo
www.prorelixresearch.com
Steps for the implementation of
the global seamless eConsent
solutions
Embrace different country strategies for eConsent
Integrate eConsent in trial planning
Optimize informed consent form digitization timelines
Train and communicate
Build a monitor advocacy program
www.prorelixresearch.com
www.prorelixresearch.com
Global regulatory environments are complex, with nuanced
differences among regions, countries and local communities.


How to Embrace different country
strategies for eConsent?
www.prorelixresearch.com
It’s important to note that while electronic signatures on an ICF
are not accepted by all agencies regulating clinical trials,
flexible, feature-rich eConsent products can be customized to
meet each site’s local laws and guidelines.
Provision of eSignature, offline signature and print-to-sign
options are all essential to ensuring trial participants, sites and
sponsors gain the full benefits of eConsent.
www.prorelixresearch.com
To ensure long-term success of global eConsent adoption,
sponsors must maintain a growing database of eConsent
signature modality acceptance, highlighting appropriate
practices country by country and region by region.
www.prorelixresearch.com
Such databases must be constantly updated with regulatory
intelligence to prevent risk noncompliance, trial delays and a
regression back to paper ICFs.
ProRelix Research
is here for the
timely execution
of your projects!
www.prorelixresearch.com

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Slider post_PR-02_27 JULY.pdf

  • 1. www.prorelixresearch.com Steps for the implementation of the global seamless eConsent solutions
  • 2. Embrace different country strategies for eConsent Integrate eConsent in trial planning Optimize informed consent form digitization timelines Train and communicate Build a monitor advocacy program www.prorelixresearch.com
  • 3. www.prorelixresearch.com Global regulatory environments are complex, with nuanced differences among regions, countries and local communities. How to Embrace different country strategies for eConsent?
  • 4. www.prorelixresearch.com It’s important to note that while electronic signatures on an ICF are not accepted by all agencies regulating clinical trials, flexible, feature-rich eConsent products can be customized to meet each site’s local laws and guidelines. Provision of eSignature, offline signature and print-to-sign options are all essential to ensuring trial participants, sites and sponsors gain the full benefits of eConsent.
  • 5. www.prorelixresearch.com To ensure long-term success of global eConsent adoption, sponsors must maintain a growing database of eConsent signature modality acceptance, highlighting appropriate practices country by country and region by region.
  • 6. www.prorelixresearch.com Such databases must be constantly updated with regulatory intelligence to prevent risk noncompliance, trial delays and a regression back to paper ICFs.
  • 7. ProRelix Research is here for the timely execution of your projects! www.prorelixresearch.com