Covered clinical study

Covered clinical studymeans any study of a drugor device in humanssubmitted in a marketing application or reclassification petition subject to this part that the applicant or FDArelies 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 FDAas to which clinical studies constitute ??covered clinical studies?? for purposes of complying with financial disclosurerequirements.

Reference:

21 Code of Federal Regulations, Ch. I

External links

• ICH Website

• FDA Website

• Clinical Research Training

• Careers in Clinical Research

• Clinical Research Services

• Clinical Research Companies Listings

• International Clinical Research Services and Corporate Trainings

• Clinical Research Abbreviations and Acronyms

• Clinical Research Glossary / Definitions

• List of Food and Drugs Regulatory Agencies

• Clinical Research: Frequently asked questions

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It uses material from the http://en.wikipedia.org/wiki/Covered+clinical+study Wikipedia article Covered clinical study.