Digital Technology in Clinical Trials

Session Chair(s)

As one of many steps for participation in a clinical trial, the informed consent process is based on a solemn and trusted interaction between a study subject and the clinical research site. Traditionally, the process involves a study subject being invited to participate in a clinical trial based on the study inclusion and exclusion criteria, reading the informed consent document (ICD) at the clinical trial site, and then having a dialogue to clarify matters. Finally, the ICD is signed manually by the study subject and the clinical investigator, and the paper copy is then given to the study subject and a hard copy stored in the subject’s study folder. With the advent of paperless, virtual and remote trials, the paper process as we know it today is a deterrent. Yet, we must be ever diligent not to lose the key purpose of the informed consent process and assure full transparency to clinical trial subjects. The current session will present the challenges and opportunities of using the eICD for domestic and global trials.

Learning Objective :

At the conclusion of this session, participants should be able to:

• Appreciate the opportunities and challenges when transitioning from paper-based ICD’s to eICD’s
• Know how to educate the study sites when transitioning from paper-based ICD’s to eICD’s
• Manage a study where both paper-based and electronic ICD’s are used
• Manage a study with disparate global regulatory and cultural differences
• Involve regulators and IRBs/EC’s when using ICD’s

Speaker(s)