Study Protocol Amendment Form

Protocol Amendment Manager

Research Compliance & Documentation

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Date	Protocol ID	Amendment #	Type	Status	Actions
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1. Study Identification

Protocol Number / IRB ID

Principal Investigator

Study Title

2. Amendment Details

Amendment Number

Amendment Date

Status

Type of Change (Select Main)

3. Rationale & Description

Rationale for Amendment (Why is this change necessary?)

Summary of Changes

Current Approved Text/Procedure

Proposed New Text/Procedure

4. Risk Assessment

Does this amendment increase risk to participants?

Yes No

Does this require Re-Consenting active subjects?

Yes No