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Clinical Trials at UC Davis Health System

Clinical Trials at UC Davis Health System

Number4IND Process: File an IND

1. Please contact CTSC (Kate Marusina, kate.marusina@ucdmc.ucdavis.edu ) for assistance with IND applications

2. Prepare IND package. Allow 4-6 weeks for IND preparation, collation, pagination, copying etc. Sometimes  the  manufacturing information (CMC Section) can be abbreviated if a)  a letter of authorization to cross-reference the original IND is available or b) if the drug is approved and product insert is available.

  • Cover Letter (Example )
  • IND (TemplateExample )
  • Fill out Form 1571, Investigational New Drug Application (Example ) . When downloading this form from the FDA website, note the OMB expiration date in the upper right corner. You form will not be accepted if it is past the expiration date. Instructions for filling out the Form1571 can be found here 
  • Fill out Form 1572, Statement of the Investigatior (Example). Frequently Asked Questions about Form 1572.
  • Fill out Certification Form 3674 (Clinicaltrials.gov attestation). Typically, you must submit the form 3674 with a new IND. Protocol amendments will require resubmission of this form (Example ). If you plan to upload your trial to Clinicaltrials.gov, but have not done it yet, mark box  b. For instructions on how to fill out, click here
  • Assemble and bind volumes using FDA-approved binders (Binder Format Requirements ):
  • Red ("Archival Binder")
  • Green ("Chemistry Binder")
  • Orange (Pharmacology Binder")

Each binder must be labeled using the FDA format (Template)

4. Each Submission contains: cover letter and IND text with forms. Create 3 copies of the whole submission 

5. Send to:

Food and Drug Adminstration
Center for Drug Evaluation and Research
Central Document Room
5901-B Ammendale Rd. Beltville, MD 20705-1266

 

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