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Janna Gonzalez

Hi Sarah,

Please look at the TMF RM v01. Mar2021.

Zone 02.01.04-Study/country/Site level document
Subsequent versions of the original protocol as well as supporting documentation that may include description of change(s) to or formal clarification of a protocol. Includes justification for a non-substantial amendment, such as administrative change

Protocol Amendment
Protocol Amendment Summary of Changes
Protocol Amendment Review and Approval
Protocol Amendment Synopsis
Protocol Amendment Administrative Changes
Justification For a Non-Substantial Amendment
Administrative Changes
Amendment Synopsis
Amendments Approval Document
Summary of Changes

04.0.101-This is a country/Site level document
Acknowledgement of Submission Receipt
IRB or IEC Submission
Request for Additional Information
Acknowledgement of Receipt
Questions and Answers
Request for Additional Info