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Clinical Trial Protocol Amendment
FDA protocol for clinical trial amendment
Your Browser Doesn't Support Canvas. Showing the Text Content of the PDF Instead: DEPARTMENT OF HEALTH
FOOD AND DRUG
ADMINISTRATION
STANDARD REQUIREMENTS FOR PROTOCOL AMENDMENT
Requirements
Letter of Intent
Guidelines
Specify the particular amendment for
proper review and evaluation
Proof of Payment
1000 php per protocol amendment
Tabulation of Summary of
Changes
Clean Copy of Revised Protocol
Changes from old to new version with
rationale
should reflect the changes