Interventional Clinical Trial or Registry Study? Writing Protocols that Demonstrate the Difference

Differentiating registry studies from interventional studies is essential in protecting research participants as well as ensuring proper regulatory compliance. While reviewing a protocol should answer the question of whether a study is interventional or a registry study, all too often, it does not.

This whitepaper addresses how sponsors and investigators can design research protocols that clearly indicate whether the clinical intervention is occurring within, or outside of the context of research, and why this distinction is critical in ensuring regulatory compliance.