O'Reilly Erin K, Hassell Nancy J, Snyder Denise C, Natoli Susan, Liu Irwin, Rimmler Jackie, Amspacher Valerie, Burnett Bruce K, Parrish Amanda B, Berglund Jelena P, Stacy Mark
Duke Translational Medicine Institute, Regulatory Affairs Office, Durham, North Carolina, USA; Duke University School of Medicine, Durham, North Carolina, USA.
Clin Transl Sci. 2015 Feb;8(1):48-51. doi: 10.1111/cts.12235. Epub 2014 Nov 12.
The Food and Drug Administration Amendments Act of 2007 (FDAAA 2007, US Public Law 110-98) mandated registration and reporting of results for applicable clinical trials. Meeting these registration and results reporting requirements has proven to be a challenge for the academic research community. Duke Medicine has made compliance with registration and results reporting a high priority. In order to create uniformity across a large institution, a written policy was created describing requirements for clinical trials disclosure. Furthermore, a centralized resource group was formed with three full time staff members. The group not only ensures compliance with FDAAA 2007, it also acts as a resource for study teams providing hands-on support, reporting, training, and ongoing education. Intensive resourcing for results reporting has been crucial for success. Due to implementation of the institutional policy and creation of centralized resources, compliance with FDAAA 2007 has increased dramatically at Duke Medicine for both registration and results reporting. A consistent centralized approach has enabled success in the face of changing agency rules and new legislation.
2007年《食品药品管理局修订法案》（2007年FDAAA，美国公法110 - 98）要求对适用的临床试验进行注册并报告结果。事实证明，满足这些注册和结果报告要求对学术研究界来说是一项挑战。杜克大学医学院已将遵守注册和结果报告规定作为高度优先事项。为了在一个大型机构内实现统一，制定了一项书面政策，描述临床试验披露的要求。此外，还成立了一个由三名全职工作人员组成的中央资源小组。该小组不仅确保遵守2007年FDAAA，还作为研究团队的资源，提供实际操作支持、报告、培训和持续教育。对结果报告进行密集资源配置对取得成功至关重要。由于实施了机构政策并创建了中央资源，杜克大学医学院在注册和结果报告方面对2007年FDAAA的遵守情况大幅提高。面对不断变化的机构规则和新立法，一致的集中式方法促成了成功。
