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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Daniel Kavanagh, PhD, responds to recent news of germline editing of human embryos in China.
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.
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