Sponsor Confidentiality Statement:

Full Title:

Trial Acronym:

Sponsor Protocol Identifier:

Original Protocol:

Version Number:

Version Date:

Amendment Identifier:

Amendment Scope:

Sponsor's Investigational Product Code(s):

Investigational Product Name(s):

Trial Phase:

Short Title:

Sponsor Name and Address:

 

Co-Sponsor Name and Address:

 

Local Sponsor Name and Address:

Device Manufacturer Name and Address:

Regulatory or Clinical Trial Identifier(s):

Sponsor Approval:

Amendment Details

Approximate Enrolled at Time of Sponsor Approval:

 Approximately enrolled

Reason(s) for Amendment:

Primary:

Secondary:

Amendment Summary:

Is this amendment likely to have a substantial impact on the safety or rights of the participants?

Is this amendment likely to have a substantial impact on the safety or rights of the participants?

Overview of Changes in the Current Amendment