Clinical Research Support

FDA

All FDA forms listed below may be downloaded directly from the FDA Forms website. The site also includes instructions and/or guidance for each of the forms referenced.

The most frequently used FDA forms associated with investigator-sponsored INDS are:

  • FDA Form 3500A, MANDATORY MedWatch Reporting
    (Please note: This is not the same as FDA Form 3500, VOLUNTARY MedWatch Reporting.)
  • FDA Form 3674, "Certification of Compliance with Requirements of ClinicalTrials.gov Data Bank"

 

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