Leveraging eConsent to Benefit
Sites and Patients
Having overseen the successful integration of eConsent into Celerion processes, Staci McDonald, Executive Director, Scientific Clinical Operations recently presented at the Veeva R&D Summit. Staci explained the reason why introducing eConsent was important to Celerion, discussed practical considerations for implementation, and explained how eConsent has helped Celerion transform their onboarding process.
Chapter 1 – Why move to eConsent?
There was a strong drive for Celerion to move away from paper consents. One of the biggest was the sheer volume of paper documents that need to be printed, signed, and stored – hundreds of thousands of pages every year!
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Chapter 2 – Practical considerations for eConsent implementation
Celerion considered a number of practical considerations to ensure successful implementation, including adaptation of existing processes, stakeholder training, ICF digitization, and ethics approval.
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Chapter 3 – The eConsent workflow
Celerion adapted the consent workflow to incorporate ethics approval of the digital consent form, screening, and signature for the paperless process.
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Chapter 4 – Outcomes
All stakeholders (site staff, participants, and clients/monitors) experienced significant benefits to the electronic process, including removing the previously significant need for copying documents, reducing the need for QC checks and follow-up, and improved access to documents and version control.
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Chapter 5 – Feedback from users
Hear what site staff, participants, and clients/monitors had to say about the eConsent experience.
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Celerion is an early phase Clinical Research Organization that focuses on Phase I and clinical pharmacology studies with three clinical pharmacology units located in Europe and the USA.
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