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In which case would a protocol amendment be required?

A sponsor shall submit a protocol amendment when a new investigator is added to carry out a previously submitted protocol, except that a protocol amendment is not required when a licensed practitioner is added in the case of a treatment protocol under 312.315 or 312.320.

What is FDA database?

The FDA Adverse Event Reporting System (FAERS) database contains information on adverse event and medication error reports submitted to FDA. The database is designed to support the FDAs post-marketing safety surveillance program for drug and therapeutic biologic products.

Do protocol amendments need to be submitted to the FDA?

A sponsor shall submit a protocol amendment for a new protocol or a change in protocol before its implementation. Protocol amendments to add a new investigator or to provide additional information about investigators may be grouped and submitted at 30-day intervals.

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