[Title 2 1, Volume 1]
[Revised as April 2003 1]
Visit from the U.S. government printing office through GPO
[quotation: 2 1CFR54.2]
[Page 295-296]
Title 2 1- food and medicine
Chapter 1-US Food and Drug Administration, Health and the Public
service
Article 54-Financial Disclosure of Clinical Research-Contents
Seconds 54.2 definition.
For the purposes of this section:
(1) Means to compensate the influence of clinical research results.
The compensation may be higher than the favorable result.
Adverse consequences, such as explicit compensation.
A favorable result or compensation in the form of investigation
A research or sponsor whose equity is covered by insurance.
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Compensation in the form of linked products, sales, royalties, etc.
Interest.
(b) Sponsorship benefits of major research covered by insurance.
Refers to any equity, stock option or other economic benefits.
Its value cannot be easily determined by referring to citizens' decisions.
Price (usually the interest of a non-publicly listed company), or
The share capital of any listed company exceeds
Implement 50,000 yuan to conduct clinical investigation in time.
Study and complete the study after 1 year.
(3) The inspected product refers to the property ownership or interest.
Interest in other financial products, including but not limited to:
Patent, trademark, copyright or license agreement.
(d) Clinical research only means listing or confirmation.
Investigators or deputy investigators directly involved.
Evaluation of therapeutic or research topics. The term also includes
Survey of spouses and dependent children.
(5) Underwriting clinical research refers to the research of any drug or equipment.
Humans are submitting applications or reclassified marketing petitions.
Established by this part of the applicant or FDA.
Whether the product is effective (including research reports, showing equivalence.
An effective product), or in any study, researchers
Make great contributions to safety demonstration. this
Generally speaking, phase or tolerance studies will not be included.
Pharmacokinetic studies, the most clinical pharmacological studies (unless they
Efficiency is a crucial decision), open security research.
In multiple locations, treatment programs and parallel tracks
Agreement. What are the clinical features of FDA that applicants can consult?
The research report ""covers the clinical research for this purpose.
Comply with financial disclosure requirements.