This document is designed to outline key considerations for sponsors when designing financial support programs for trial participants by:

• Categorizing non-medical items most likely to have a financial impact on prospective and current study participants

• Illustrating unique considerations for patients and caregivers under various circumstances

• Highlighting pertinent regulatory guidance around coercion and undue influence of clinical trial participants

• Recommending sponsor approaches for relieving financial burden associated with non-medical, out-of-pocket costs incurred by trial participants