The Importance of Quality in the Informed Consent Process

For decades, issues with paper-based consent have been the source of the most common and most significant violations raised by Global Health Authority inspectors. In 2019 alone, more than 1/3 of all issued US Food and Drug Administration (FDA) Form 483s were related to informed consent findings, while the European Medicines Agency (EMA) reported that consent issues represented the 4th highest cause of critical inspection findings and the 5th highest cause of all site inspection findings.

These errors are costly, time-consuming and can jeopardize the completion of a trial. And these issues cannot be remediated with the continued use of paper-based consent, as they stem from the physical properties of paper itself.

That is why more and more sponsors have switched from paper consent to eConsent. But making this change must be more than just digitizing paper consent forms, the need for a complete informed consent process that better educates and retains patients while minimizing errors is key.

Join this webinar as industry experts identify the most common issues with the paper-based consent process, and what to look for in a complete consent management solution in order to reduce quality issues while improving oversight.

What You Will Learn:

  • The most common informed consent issues
  • How a digitally enabled consenting process solves these issues
  • How to ensure quality by standardizing processes and deploying effective good clinical practice (GCP) training
  • How to deploy eConsent globally with regulatory compliant configurations and workflows

Vice President & General Manager, eConsent at Medable

Shyanne Ali has over 20 years of pharmaceutical drug development experience in the areas of Global Clinical Operations, Global Clinical...

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