Get 3674 Form

The 3674 Form is a crucial document for compliance with ClinicalTrials.gov requirements. This guide provides clear, step-by-step instructions to help users fill out the form online with ease and accuracy.

Follow the steps to effectively complete the 3674 Form online

1. Click the ‘Get Form’ button to access the form and open it for online completion.
2. Enter the name of the sponsor, applicant, or submitter as it appears on the application. Ensure that it matches exactly to avoid any inconsistencies.
3. Input the date of the application or submission that this certification supports.
4. Provide the full address, including the number, street, state, and ZIP code of the sponsor, applicant, or submitter.
5. Enter the telephone and fax numbers, including the area code, for the sponsor, applicant, or submitter to ensure that they can be contacted if needed.
6. If applicable, list all drug, biologics, or device names associated with the submission. It’s important to include all known names to promote clarity.
7. Select the type of application or submission by checking the relevant box, ensuring the type is correctly identified.
8. If a number (such as IND, NDA, and others) has previously been assigned to the application, enter that number in the designated field.
9. If there is a serial number associated with the application, include it in the appropriate field or leave it blank if none exists.
10. Choose one of the checkboxes A, B, or C to indicate the applicability of 42 U.S.C. § 282(j) regarding clinical trials referenced in the submission.
11. If Checkbox C was selected, include the National Clinical Trial (NCT) number(s) for applicable clinical trials referenced in this certification.
12. Ensure the sponsor, applicant, or an authorized representative signs the form in the designated signature field.
13. Input the name and title of the person who signed the certification in the previous step.
14. Provide the full address, telephone, and fax numbers of the individual who signed the certification.
15. Finally, enter the date on which the certification is signed. This date may differ from the application date earlier provided.
16. Once all sections are completed, save your changes, and if necessary, download, print, or share the completed form.

Start filling out your documents online today for a streamlined submission process.