Get Physician''s Checklist For An Ind Application For Emergency Treatment - Fda

This guide aims to assist users in completing the Physician's Checklist for an IND Application for Emergency Treatment at the FDA. Whether you are a treating physician or an IND application sponsor, this step-by-step walkthrough will help you navigate the online form effectively.

Follow the steps to complete the checklist online smoothly.

1. Press the ‘Get Form’ button to access the checklist form and open it in your online document management system.
2. In the first section, enter the Emergency IND sponsor’s name and contact information. This will be recorded after your initial communication with the FDA.
3. Provide the IND application number assigned by the FDA and the date of contact in the designated fields.
4. Fill in the FDA contact name, division, and phone number for reference.
5. In the sponsor information section, enter the details of the treating physician, including their name, affiliation, phone, fax, address, and email. If applicable, also include the sponsor of the emergency IND application.
6. Carefully review and ensure that all criteria for the emergency IND application are met. Provide justification for why the treatment is medically necessary in the patient's case.
7. Complete the drug supply reference statement, including information about the IND supplier and whether they have agreed to provide the drug.
8. Document the investigator's qualifications, including training, experience, and whether a CV has been attached.
9. Fill out the patient’s information, including ID, gender, date of birth, weight, race, diagnosis, and disease status. Include additional information about previous therapies and responses.
10. Outline the proposed treatment plan, including any relevant references, rationale, patient monitoring procedures, and modifications for toxicity.
11. Ensure informed consent is obtained, documenting the signature and date, and note notifications regarding IRB within the required timeframe.
12. Finally, review all sections for completeness and accuracy before submitting the form.
13. Once you have filled out the checklist, you can save your changes, download the form, print it, or share it as needed.

Start completing your Physician's Checklist for an IND Application for Emergency Treatment online today.