临床试验要求

Clinical 试用 must comply with many requirements that do not apply to other types 人类受试者的研究. These requirements are designed to address the increased participant vulnerability and risks of many clinical 试用 compared with other research. 它们也意味着确保有意义的结果. 下面我们介绍一些主要的 适用于临床试验的要求.

修订后的共同规则会影响我的研究吗?

同意表格投寄要求

Under the revised human subjects protection regulations (known as the revised “Common Rule”) that took effect on January 21, 2019, one IRB-approved consent form must be 贴在 a publicly-available federal website for each clinical trial funded by any federal agency or department that has adopted the Common Rule. 20个联邦机构 and departments, including HHS, have adopted the Common Rule – for a complete list of federal agencies and departments that have adopted the Common Rule, see http://www.hhs.gov/ohrp/regulations-and-policy/regulations/common-rule/index.html.

For purposes of this consent form posting requirement, a “clinical trial” is defined as: a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes. 45 CFR 46.102(b).

Social, behavioral, and educational research studies funded by a Common Rule department or agency and that fit the 定义 of clinical trial in 45 CFR 46.102(b)也必须 遵守张贴规定.

To further understand how the clinical trial 定义 applies to your research, 你可以找到 国家卫生研究院 website for Definitions of 临床试验 Case Studies 有帮助的. The website gives examples of studies that are considered a clinical trial 而那些不是.

良好临床操作训练

每 国家卫生研究院的政策, all 国家卫生研究院-funded clinical investigators and clinical trial staff who are involved in the design, conduct, oversight, or management 临床试验 must be trained 良好临床操作规范(GCP).

什么是临床试验.政府?

临床试验结果的注册和报告

临床试验.政府 is a publicly available registry and results database of federally and privately supported clinical 试用 conducted in the United States and around 世界. 临床试验的目的.政府要向公众公开密钥信息 about clinical 试用 that are currently available or previously conducted. 临床试验.政府 captures summary protocol information before and during the trial as well as summary results and adverse event information of a completed trial. 联邦法律、法规 and editors of prominent medical journals require registration 一个临床试验, 如下所述.

我如何决定我是否必须遵守?

A 火博体育大学 investigator who conducts a clinical trial must comply with these 需求如果:

• 她或他是首席研究员(PI)， AND
• The study is investigator-initiated (the clinical trial is not an industry trial in which the protocol is developed, owned, and sponsored by a company. 行业的赞助商 谁负责登记他们的试验.)

What kind of studies need to be 贴在 临床试验.Gov和何时?

见下表的临床试验摘要.政府注册要求:

All investigator-initiated clinical 试用 must register on 临床试验.政府 to comply with federal 食品及药物管理局 requirements outlined in 食品及药物管理局 42 CFR 11 (Final Rule) and/or other federal agencies and department’s policy or requirements. 研究表明 under multiple registration requirements only need to be registered once. 的信息 贴在 临床试验.政府 must be updated throughout the course of the trial, verified at least every 12 months, 研究结束时必须提供结果.

重要提示: Even if your investigator-initiated clinical trial does not meet the 国家卫生研究院 or 食品及药物管理局 clinical 试用 registration requirements, you are strongly advised to read and consider registering your trial to comply with the following additional requirements:

•  国际医学期刊编辑委员会 (ICMJE) for publications purposes
• 医疗保险中心 & Medicaid for research billing claims for qualifying clinical 试用
• Research funders now requiring registration and results reporting

我还该考虑什么呢?

我，我，我 试验:
The holder of any IND, IDE, or HDE from the 食品及药物管理局 must ensure compliance.

国家卫生研究院资助的试验:
主要获奖者必须确保遵守规定.