Get Va 10-9012 1989-2025

Filling out the VA 10-9012 form online is a crucial step in documenting investigational drug information. This guide provides a step-by-step approach to ensure you complete each section accurately and efficiently.

Follow the steps to successfully complete the VA 10-9012 form.

1. Click ‘Get Form’ button to obtain the form and open it in the editor.
2. Begin with section 1 by entering the title of the study. This should reflect the specific investigational drug project you are documenting.
3. In section 2, list the responsible investigator who signed Form FD-1573, providing their full name and position.
4. If the principal investigator differs from the responsible investigator, fill in their details in section 3.
5. In section 4, include all designations for the drug. Please ensure you provide the generic, chemical, code, and trade names.
6. Complete section 5 by naming the manufacturer or other sponsor responsible for the drug.
7. For section 6, indicate the source of the drug if it is not the manufacturer or sponsor listed previously.
8. Section 7 requires information on the therapeutic classification and expected therapeutic effects. Clearly describe these attributes.
9. In section 8, document the dosage forms and strengths. Be specific about the format and concentrations of the drug.
10. Complete section 9A by indicating whether the drug is a controlled substance. If 'Yes,' proceed to section 9B to classify the substance.
11. Section 10 details the stability and storage requirements. Specify whether storage is at room temperature, in the refrigerator, in a freezer, or protected from light. Indicate any additional requirements.
12. In section 11, describe drug administration procedures, including the routes of administration and any necessary directions.
13. Complete section 12 by indicating who administers the drug and provide their relevant details in section 12B.
14. Section 13 requires you to specify the usual dosage range for the drug.
15. In section 14, list any known side effects and toxicities associated with the drug.
16. Section 15 inquires about double-blind status, along with the name and contact details of the individual responsible for the code designation if applicable.
17. Detail any special precautions in section 16, including possible drug interactions and contraindications.
18. Specify any antidote information in section 17.
19. In section 18, check the appropriate status of the drug—whether it is investigational, commercially available, or in a specific phase.
20. List the names of authorized prescribers in section 19. Include all relevant prescribers.
21. Have the responsible or principal investigator sign the form in section 20 and include the date.
22. Complete any required approvals in section 21, along with the signatures of chairpersons.
23. Finally, provide patient identification in section 22. Once all sections are completed, save your changes, download, print, or share the form as necessary.

Begin filling out your VA 10-9012 form online today to ensure timely processing.