Get Form Fda 1572 - Transcelerate Biopharma Inc. Transcelerate ...

Completing Form FDA 1572 is a crucial step for principal investigators involved in clinical trials. This guide will provide a clear and supportive overview of the process to ensure all required information is accurately submitted.

Follow the steps to effectively complete the form.

1. Click ‘Get Form’ button to obtain the form and open it in your preferred editing tool.
2. In Section 1, enter the full legal name of the principal investigator. Ensure this matches any associated medical or professional licenses. Provide the full mailing address, which cannot be solely a P.O. Box. Ensure it's clear and legible.
3. In Section 2, check either the Curriculum Vitae (CV) box or the Other Statement of Qualifications box to confirm that the documentation of experience has been sent in. The document must be current and in English.
4. In Section 3, provide the address where study subjects will be seen. If this address is the same as in Section 1, do not use 'None' or 'Same as Section 1.' Include a full street address for all study sites.
5. In Section 4, list all laboratories used in the study, ensuring full addresses are included. Avoid abbreviations for P.O. Box addresses.
6. In Section 5, document the name and address of the Institutional Review Board (IRB) or Ethics Committee, ensuring that this matches other approval documentation.
7. In Section 6, identify sub-investigators. They should contribute significantly to the study and must have their full names recorded as they appear in their professional documentation.
8. In Section 7, input the study number and full title of the protocol in English. Include the sponsor's name if applicable, and note if any amendments necessitate a title change.
9. In Section 8, check the appropriate box indicating the phase of the study. Ensure details are in alignment with prior sections.
10. In Section 9, accept all commitments required for conducting the trial under IND, ensuring clarity and completion.
11. In Sections 10 and 11, the principal investigator must sign and date the form. Ensure that the date follows the format (mm/dd/yyyy) and that it follows the completion of the form.
12. Review the form for completeness, ensuring no sections are left blank. Use 'N/A' where necessary, and submit accordingly to the sponsor.

Begin filling out your Form FDA 1572 online today to facilitate a smooth submission process.