临床试验注册

Registering 临床试验 when they begin, 提供及时的更新, 提交总结结果, and making this information publicly available fulfills a number of purposes and benefits a variety of people.

资料来源:Zarin DA, Keselman A.  Registering a clinical trial in 临床试验.政府. 胸部. 2007;131(3):909-12. [ 全文]

临床试验.政府 is an online resource (also referred to as a "registry") that provides the public, 研究人员, 患者及其家属, and health care professionals access to information on publicly and privately supported clinical studies. The website is maintained by the National Library of Medicine (NLM) at the National Institutes of Health (NIH).

临床试验信息.政府 is provided and updated by the sponsor or principal investigator of the clinical study. Studies are generally submitted/registered to 临床试验.政府 when they begin, and the information is updated throughout the study. In some cases, the results of the study are submitted after the study ends. 所有 临床试验 receiving federal grant support must be registered to meet compliance with the law.

Clinical trials receiving federal grant support.

药物及生物制品临床试验: Controlled, clinical investigations of a product subject to FDA regulations.

Clinical Trials of Devices: Controlled trials with health outcomes, 除了小型的可行性研究, 以及儿科上市后监测.

The International Committee of Medical Journal Editors (ICMJE) requires certain research studies to be registered at 临床试验.政府 in order to be considered for publication in ICMJE member journals and other publications that adhere to ICMJE Uniform Requirements for Manuscripts Submitted to Biomedical Journals: “Any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes.这个定义包括 一期试验. Interventions include “any intervention used to modify a biomedical or health-related outcome (for example, 药物, 外科手术, 设备, 行为治疗, 饮食干预, 护理过程也发生了变化).” Health outcomes include “any biomedical or health-related measures obtained in patients or participants, 包括药代动力学测量和 不良事件. 纯粹的 观察性研究 (those in which the assignment of the medical intervention is not at the discretion of the investigator) will not require registration. The ICMJE accepts registration in any registry that is a primary register of the WHO International Clinical Trials Registry Platform (ICTRP) 或在 政府, ICMJE endorses these registries because they meet several criteria. They are accessible to the public at no charge, 对所有潜在注册人开放, managed by a not-for-profit organization, have a mechanism to ensure the validity of the registration data, 并且可以电子搜索. An acceptable registry must include the minimum 20-item 这里是试验注册数据集.

• Request a user login name and temporary password, by sending an email to bilicek@uiwtx.edu. 将临床试验的地方”.Gov注册”.
• Include in the message your name, telephone number, and email address
• You will then receive an email with your login name and a temporary password.
• 至: 临床试验.政府 并按照说明登录.
• In the “Organization” field, type “UniversityIW”
• Change your password under "User Account" 在“主菜单”页面
• 注册一项研究, 在“主菜单”页面, 在“协议记录”下, click "Create" and complete the study description template.
• 一旦完成，提交研究.
• The UIW PRS Administrator will verify the entry and approve it for release to the clinicaltrials.政府注册.

• 定期更新(e.g.(如研究完成).
• 提交任何 不良事件. Submission of 不良事件 to the IRB separately may be required as well.
• 提交基本研究结果和 periodic updates during and at the end of the trial.