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