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.
Other content in this Stream
In 2018 WIRB approved 100% of the single-patient EA requests that were submitted for review.
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.
On January 21, 2019, most federally funded research will need to follow the 2018 Requirements of the Common Rule. This post talks through the original and revised rules, and how they may apply to you.
