Part 1: Direct Interactions Between Sponsors and Research Participants: A Legal Perspective

There has been an increase in sustained interactions between sponsors of clinical research or their designees and potential and enrolled study participants and their families. Sponsor interactions with study participants and their families raise certain legal and regulatory concerns when sponsors perform the functions of investigators, such as taking medical histories or securing records from third-party health care providers, or when interactions contribute to inaccurate participant perceptions regarding who is responsible for their participation in a study, among other things.

Deliverables