英语翻译[Code of Federal Regulations][Title 21,Volume 1][Revised

英语翻译
[Code of Federal Regulations]
[Title 21,Volume 1]
[Revised as of April 1,2003]
From the U.S.Government Printing Office via GPO Access
[CITE:21CFR54.2]
[Page 295-296]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION,DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 54--FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS--Table of Contents
Sec.54.2 Definitions.
For the purposes of this part:
(a) Compensation affected by the outcome of clinical studies means
compensation that could be higher for a favorable outcome than for an
unfavorable outcome,such as compensation that is explicitly greater for
a favorable result or compensation to the investigator in the form of an
equity interest in the sponsor of a covered study or in the
[[Page 296]]
form of compensation tied to sales of the product,such as a royalty
interest.
(b) Significant equity interest in the sponsor of a covered study
means any ownership interest,stock options,or other financial interest
whose value cannot be readily determined through reference to public
prices (generally,interests in a nonpublicly traded corporation),or
any equity interest in a publicly traded corporation that exceeds
$50,000 during the time the clinical investigator is carrying out the
study and for 1 year following completion of the study.
(c) Proprietary interest in the tested product means property or
other financial interest in the product including,but not limited to,a
patent,trademark,copyright or licensing agreement.
(d) Clinical investigator means only a listed or identified
investigator or subinvestigator who is directly involved in the
treatment or evaluation of research subjects.The term also includes the
spouse and each dependent child of the investigator.
(e) Covered clinical study means any study of a drug or device in
humans submitted in a marketing application or reclassification petition
subject to this part that the applicant or FDA relies on to establish
that the product is effective (including studies that show equivalence
to an effective product) or any study in which a single investigator
makes a significant contribution to the demonstration of safety.This
would,in general,not include phase l tolerance studies or
pharmacokinetic studies,most clinical pharmacology studies (unless they
are critical to an efficacy determination),large open safety studies
conducted at multiple sites,treatment protocols,and parallel track
protocols.An applicant may consult with FDA as to which clinical
studies constitute ``covered clinical studies'' for purposes of
complying with financial disclosure requirements.

联邦法规]
[标题21,第1卷]
[修改为4月1日,2003]
从美国政府印刷局通过GPO的访问
[引述：21CFR54.2]
[295-296页]

标题21 - 食品和药品

第一章 - 食品和药物管理局,卫生与公众
服务

第54--FINANCIAL披露临床调查 - 目录

秒. 54.2定义.
对于这部分的目的：
（1）补偿的临床研究结果的影响的手段
赔偿,可能会比一个有利的结果高出
不利的结果,如赔偿明确更大
一个有利的结果或赔偿,在调查的形式
股权在保险范围内的研究或赞助商
[[296页]]
补偿的形式挂钩的产品,销售,如版税
兴趣.
（b）在保险范围内的重大研究的赞助商权益
指任何股权,股票期权或其他经济利益
其价值不能轻易通过参考市民的决定
价格（通常,在一个nonpublicly上市公司利益）,或
任何一家上市公司的股权超过
50,000元,在时间的临床调查是贯彻
学习和1年后完成研究.
（三）在被检测的产品是指财产所有权或利益
其他金融产品的兴趣,包括但不限于,
专利,商标,版权或许可协议.
（四）临床调查仅仅意味着上市或确定
调查员或subinvestigator谁是直接参与
治疗或研究课题评价.本术语还包括
配偶及受扶养子女每人的调查.
（五）涵盖临床研究是指任何一种药物或设备的研究
人类在提交申请或重新分类的营销呈请
受这部分申请人或FDA依靠建立
该产品是有效的（包括研究报告,显示等价
一个有效的产品）,或任何一个单一的研究中,研究者
使得一到安全示范重大贡献.这
将在一般情况下,不包括阶段或耐受性研究
药代动力学研究,临床药理学研究中最（除非他们
效能是至关重要的一个决心）,大开放的安全性研究
在多个地点进行,治疗方案和并行轨道
协议.申请人可以查阅美国FDA的临床有哪些
研究构成'' ``涵盖临床研究为目的
遵守财务披露要求.