eConsent For Complex Clinical Trials

By Karen Maduschke, Sr Director & General Manager, IQVIA Complete Consent and Vinita Navadgi, Sr Director, Product & Strategy, IQVIA Complete Consent

Capturing patient informed consent is a vital step in any clinical trial. Before a patient starts treatment, and any time a protocol is amended or a patient status changes, consent forms need to be signed and stored in the study database to demonstrate compliance.

As studies become more complex, sites may find themselves juggling dozens of different consent documents that need to be completed on different timelines by different study populations. If these consent steps get overlooked or the documentation is lost, it can put the entire study at risk.

Using an electronic consent platform (eConsent) can mitigate these risks, making it easy for sites, sponsors, and patients to keep consent forms up to date.

In this paper, we will explore how sponsors can use eConsent platforms to deliver highly engaging and easy-to-audit consent processes that cut time and cost while creating a seamless user experience.