Glossary of Terms

Form FDA 1571

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Clinical: Biopharma
Drug Trials

The Form FDA 1571 is used to obtain agreement from a sponsor or sponsor-investigator to conduct research in adherence to all appropriate FDA regulations. It also serves as a cover sheet and is completed for every submission sent to the FDA on behalf of a specific IND. You should include the following information on the 1571:

  • Contact information and mailing address of the Sponsor (or Sponsor Investigator)
  • IND number, if it has been issued
  • Serial number  
  • The name(s) of the drug/biologic and the indication being studied
  • The contents of the submission
  • Name and title of the individuals responsible for monitoring the study and reviewing safety data