Get Va Investigational Drug Information Record Form 10-9012 - Etsu

The VA Investigational Drug Information Record Form 10-9012 - Etsu is essential for documenting investigational drug studies undertaken by the Department of Veterans Affairs. This guide provides clear, step-by-step instructions to help you complete the form online with confidence.

Follow the steps to accurately fill out the VA Investigational Drug Information Record Form

1. Press the 'Get Form' button to access the form and open it in your online editor.
2. Enter the title of the study in the designated field to provide a clear reference for your submission.
3. Fill out the responsible investigator's information, ensuring the individual's designation is correctly recorded.
4. If the principal investigator is different from the responsible investigator, provide their details as well.
5. Complete the section for all designations of the drug, including its generic name, chemical code, and trade names.
6. Document the manufacturer or sponsor of the drug accurately to ensure traceability.
7. In the therapeutic classification and expected therapeutic effects section, detail how the drug is intended to benefit users.
8. List the dosage forms and strengths available for the drug in the specified section.
9. Indicate whether the drug is a controlled substance by selecting 'Yes' or 'No' and, if applicable, complete the classification.
10. Outline the stability and storage requirements by checking the appropriate boxes and providing necessary specifications.
11. Provide details on the routes of drug administration by selecting the applicable boxes and describing the administration directions.
12. Specify who will administer the drug and complete the route in the provided sections.
13. Detail the usual dosage range to guide practitioners in administering the drug.
14. List known side effects and toxicities associated with the drug to ensure safety.
15. If the study is double-blind, indicate this and provide relevant contact information.
16. Note any special precautions, including drug interactions and contraindications.
17. If applicable, document any antidote related to the drug.
18. Choose the status of the study from the options provided, specifying which phase it is in or if it is commercially available.
19. List the names of authorized prescribers in the appropriate sections.
20. Ensure the signature of the responsible or principal investigator is completed, along with the date of signing.
21. Fill out the patient identification details as required.
22. Obtain signatures from the chairperson for the subcommittee on human studies and the research and development committee, along with the respective dates.
23. Once you have reviewed the form for accuracy, save your changes, and utilize the options to download, print, or share the form as needed.

Complete the VA Investigational Drug Information Record Form 10-9012 - Etsu online today to ensure a comprehensive submission.