Get Form 1571

Filling out Form 1571, the Investigational New Drug Application, is a crucial step in initiating clinical investigations. This guide will provide you with clear instructions on how to complete the form online, ensuring you have all necessary information readily available.

Follow the steps to successfully complete Form 1571 online

1. Click 'Get Form' button to obtain the form and open it in your online editor. This allows you to begin filling out the necessary information.
2. Enter the name of the sponsor in the designated field. This is the individual or organization responsible for the investigational new drug.
3. Provide the date of submission. This is the date you are filling out and submitting the application.
4. Fill in the full address of the sponsor, including the number, street, city, state, and zip code.
5. Include the telephone number of the sponsor, ensuring to provide the area code.
6. List all names associated with the drug, including trade, generic, chemical, and code names.
7. If the investigational new drug has previously been assigned an IND number, include it in the appropriate field.
8. Indicate the indications covered by this submission, clearly stating what the application addresses.
9. Select the phase(s) of clinical investigation that will be conducted, marking Phase 1, Phase 2, Phase 3, or any other if applicable.
10. If applicable, list the numbers of all investigational new drug applications or related documents referenced in your application.
11. Consecutively number your submissions, starting with 'Serial Number: 0000' for the initial submission.
12. Check any applicable items that are included with this submission, such as initial IND application or protocol amendments.
13. If part of the study will be conducted by a contract research organization, acknowledge this and detail any obligations transferred.
14. Provide the name and title of the person responsible for monitoring the conduct and progress of the investigations.
15. List the names and titles of those responsible for reviewing and evaluating safety information regarding the drug.
16. Read and agree to the stipulations regarding the commencement of clinical investigations, ensuring compliance with regulatory requirements.
17. Enter the name of the sponsor or the authorized representative, along with their signature.
18. Add the address and telephone number of the sponsor or authorized representative.
19. Provide the date of signing the form at the end.
20. Once all fields are filled, you can save your changes, download the form, print it, or share it as needed.

Begin completing your Form 1571 online to facilitate the submission of your investigational new drug application.