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FDA
Requirements
Clinical Investigator (individual who conducts the study)
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FDA 1572 (drug)
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Investigator Agreement (device)
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Serious Adverse Event reports submitted to Sponsor
Sponsor-Investigator (individual who initiates and conducts the study)
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Clinician Investigator requirements 1 or 2
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Original application and all subsequent submissions to the FDA:
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IND Application (drug)
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IDE Application (device)
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Amendments to the Application
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Adverse Event Reports
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Annual Reports
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Form 3674, Certification of Registration to ClinicalTrials.gov
Tips / Additional Information
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The form FDA 1572/Investigator Agreement identifies the facilities where the research will take place, the reviewing/approving IRB and sub-investigators participating in the study. The 1572 should be updated if changes are made during the course of the investigation.
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An IND Application must be filed when a sponsor wishes to test a newly developed drug or the use of a drug that is not yet approved by the FDA for marketing (21 CFR 312).
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The Form FDA 1571 is the cover sheet for the Investigational New Drug Application and should be included in all subsequent submissions to the FDA. Instructions for completing this form and the 1572 is available at: http://www.fda.gov/cder/forms/1571-1572-help.html
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An IDE Application must be filed for any device that poses significant risk (21 CFR 812).
