Maintaining Your Award

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Throughout the award, you must comply with the reporting requirements below:

• Our Clinical Terms of Award.
• For electronic submissions, the Grant Application Guide for your Grant Application Package.
• For paper submissions, the PHS 398.

Always promptly inform your program or project officer of major changes to the protocol and any reports to FDA, including:

• Protocol amendments.
• Protocol termination.
• Temporary suspension of the protocol.
• Change in informed consent or IRB or IEC approval status.
• Temporary suspension or permanent termination of patient accrual.
• Other problems or issues that could affect study participants.
• FDA communications.

Additional Resources

• Human Subjects Reporting Requirements: When to Report to Your Program or Project Officer checklist

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