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.
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The IRB at Inova Health System of Falls Church, VA, began working with a central IRB 15 years ago. Since then, the IRB developed a well-organized process for its partnerships with independent IRBs.
Studies show clinical trial participants want to know what was learned from their involvement. Many sponsors are implementing plans to deliver plain language summaries to trial participants.
Dissatisfied with its electronic IRB research management solution, OhioHealth Research & Innovation Institute searched for a solution to improve compliance, efficiency, customer service, and cost.
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