Get Study Amendment - Indiana University East

This guide provides a clear and comprehensive overview of the process for completing the STUDY AMENDMENT form for Indiana University East. Accurately filling out this form is essential to ensure all proposed changes are appropriately reviewed and approved by the Institutional Review Board.

Follow the steps to successfully complete the STUDY AMENDMENT form.

1. Click ‘Get Form’ button to access the amendment form and open it in your chosen editor.
2. Begin with Section I: Investigator Information. Fill in the following fields: your full name (last, first, middle initial), school affiliation, building and room number, contact phone number, and email address. Include the project title and the sponsor or funding agency.
3. Move to Section II: Amendment Description. Clearly describe the proposed changes in the provided space. Ensure that your rationale for these amendments is well-articulated.
4. Indicate whether the study is sponsored by an external agency. If yes, check the appropriate line and prepare to attach relevant documentation.
5. Assess if the proposed changes alter the balance of risks and benefits for subjects. Your response is crucial in understanding the impact of the changes.
6. Evaluate if the amendments affect any previously submitted documents. If so, select the applicable documents and ensure revisions are highlighted.
7. Determine if changes to the informed consent and/or assent documents are necessary. If changes are made, indicate whether they are additions or replacements of the current documents.
8. Complete the section regarding amendment inclusion, listing any informed consent, surveys, recruitment materials, or protocols being amended, and ensure relevant documents are included.
9. Specify the type of amendment you are submitting: a minor or major amendment, based on the implications of the changes.
10. Finally, sign and date the form, confirming the information provided is accurate and complete.
11. Submit your completed amendment form along with any additional documentation needed for the IRB review, ensuring all changes are saved and shared as required.

Complete your STUDY AMENDMENT form online to ensure a smooth review process.