Extract to table

The statute and regulations do not distinguish between payments that are proper and those that may raise compliance concerns; all payments to covered recipients must be reported, regardless of their legitimacy or business justification

Importantly, even where individual transfers fall below the de minimis threshold, they must be tracked because the aggregate cap applies on a per-covered-recipient, per-calendar-year basis

To qualify for delayed publication, the research payment must satisfy three conditions: 1

The payment must be made pursuant to a written agreement or protocol for the conduct of research

The research must constitute a "systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge

For clinical trials, the payment must be associated with a research study registered on ClinicalTrials