求高人翻译段英文哈2 多谢多谢(f) Significant payments of other sorts means payments made by the sponsor of a covered study to the investigator or the institution to support activities of the investigator that have a monetary value of more
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求高人翻译段英文哈2 多谢多谢(f) Significant payments of other sorts means payments made by the sponsor of a covered study to the investigator or the institution to support activities of the investigator that have a monetary value of more
求高人翻译段英文哈2 多谢多谢
(f) Significant payments of other sorts means payments made by the
sponsor of a covered study to the investigator or the institution to
support activities of the investigator that have a monetary value of
more than $25,000, exclusive of the costs of conducting the clinical
study or other clinical studies, (e.g., a grant to fund ongoing
research, compensation in the form of equipment or retainers for ongoing
consultation or honoraria) during the time the clinical investigator is
carrying out the study and for 1 year following the completion of the
study.
(g) Applicant means the party who submits a marketing application to
FDA for approval of a drug, device, or biologic product. The applicant
is responsible for submitting the appropriate certification and
disclosure statements required in this part.
(h) Sponsor of the covered clinical study means the party supporting
a particular study at the time it was carried out.
[63 FR 5250, Feb. 2, 1998, as amended at 63 FR 72181, Dec. 31, 1998]
求高人翻译段英文哈2 多谢多谢(f) Significant payments of other sorts means payments made by the sponsor of a covered study to the investigator or the institution to support activities of the investigator that have a monetary value of more
f 其他各种支付手段的重大付款保险范围内的赞助商的调查研究或机构调查员具有货币价值的支持活动超过25000美元,对成本进行独家临床研究或其他临床研究（例如,用于正在执行的补助金研究,赔偿的设备或家臣形式进行咨询或酬金）在时间的临床调查人开展学习1年后完成工作研究.
g 申请人是指一部分像那种可以提出一个营销的应用美国FDA的药物,设备,或生物制剂批准的人.申请人是提交相应的证明和负责在这部分需要披露报表.
h 涵盖临床研究的赞助是指支持它在特定时间进行了研究的部分.