Get Requesting An Ind Consult From The Fda - Suny Upstate Medical ... - Upstate

This guide provides clear, step-by-step instructions for filling out the Requesting An IND Consult From The FDA form. By following these outlined steps, users can ensure a smooth submission process for their study proposals.

Follow the steps to successfully complete the IND consult request.

1. Click the ‘Get Form’ button to obtain the form and open it in the editor.
2. Ensure to have a completed SUNY IRB application packet for your study, obtained from the IRB website for the most current version.
3. Fill out the FDA Form #1571 and Form #1572 with information regarding your study, Principal Investigator, and SUNY Upstate as the institution. Locate these forms on the FDA's website.
4. Refer to the FDA instructions on submitting materials and filling out the forms, available on their website. Send these documents to the correct address specified in the instructions.
5. Compose a cover letter detailing your request, including your contact information, study title, a brief summary of the study, and justification for its necessity.
6. Dispatch all materials using a certified carrier (UPS or FedEx) to obtain a guaranteed delivery date and receipt.
7. Be patient as the review process typically takes up to 30 days from when the FDA receives your materials.
8. Keep a record of all shipping receipts and correspondence with the FDA, organizing them within the regulatory binder under 'FDA Materials.'

Start filling out your IND consult request form online today for a seamless submission process.