临床试验.政府登记

临床试验.政府 is a online resource (also referred to a "registry") that provides the public, 研究人员, patients and their family members, and health care professionals access to information on publicly and privately supported clinical studies. 的 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, results of the study are submitted after the study ends.

需要注册什么?

1. Clinical Trials of Drugs and Biologics: Controlled, clinical investigations of a product subject to FDA regulations.

2. 仪器的临床试验: Controlled trials with health outcomes, other than small feasibility studies, and pediatric post-market surveillance.

3. 的 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.

4. “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.” This definition includes Phase I trials. 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, dietary interventions and process-of-care changes).” Health outcomes include “any biomedical or health-related measures obtained in patients or participants, including pharmacokinetic measures and adverse events. Purely observational studies (those in which the assignment of the medical intervention is not at the discretion of the investigator) will not require registration.

我如何注册?

1. Request a user login name and temporary password by sending an email to 便雅悯.kennedy@mu.edu.

a. 将临床试验的地方”.政府 registration" in the subject line.

b. Include in the message your name, telephone number, email address, study title and MU HR# (e.g., HR-9999).

2. You will then receive an email with your login name and a temporary password.

3. 访问:http://register.临床试验.Gov /并输入用户名.

a. In the “Organization” field, type “ 葡京游戏在线网址U.”

b. Change your password under "User Account" 进入“主菜单”页面.

4. 注册研究, 进入“主菜单”页面, 协议记录,” click "Create" and complete the study description template.

5. When you get to the information about Review Board, the following please complete the fields as follows:

      • Unique Protocol ID: Refers to a sponsor-provided number. Otherwise, use grant number or MU IRB number.
      • Board Approval Number: Refers to the MU IRB number that begins with "HR-".
      • Board Name: 葡京游戏在线网址 IRB.
      • Board Affiliation: 葡京游戏在线网址
      • Board 联系: Benjamin Kennedy; (414) 288-1479, 便雅悯.kennedy@mu.edu; Schroeder Complex 102, PO Box 1881, Milwaukee, WI 53201.
      • Oversight Authority: Enter "United States: 院校检讨委员会" or if FDA regulated, "United States: Food and Drug Administration."

6. 一旦完成,提交研究.

7. 的 Office of 研究合规 will verify the entry and approve it for release to the 临床试验.政府注册.

Do I need to do anything once I register my study?

1. 定期更新(例如.g.,研究已完成). 的 “Record Verification Date” field should be updated in conjunction.

2. 提交任何不良事件. Submission of adverse events to the IRB separately may be required as well.

3. 提交基本研究结果.

我如何获得更多信息?