What to file in Artifact ‘Amendment’ (02.01.04)

[Sarah Wilmschen]

Dear all,
I have a question regarding protocol amendments.
Which documents exactly do you file in artifact 02.01.04 and what should be filed in 04.01.01 from the documents submitted to RA/EC with regard to amendment (e.g. cover letter, Substantial Amendment Notification Form, the new protocol (including signature page))?
Thanks a lot in advance!

[Janna Gonzalez]

Hi Sarah,

In Zone 02.01.04 I would filed.
Protocol Amendment
• Protocol Amendment
• Administrative Changes
• Amendment Synopsis
• Amendments Approval Document
• Summary of Changes
• Justification for a Non-Substantial Amendment
• Protocol Amendment (CSR component)

In Zone 04.01.01

IRB or IEC Submission
• IRB or IEC Initial Submission
• IRB or IEC Continuing Review Submissions
• IRB or IEC Correspondence
o Acknowledgement of Receipts
o Questions and Answers
o Request for Additional Info
o IEC from Site
o Cover letters only responses to IRB or IEC from Site

Hope this helps!
Janna

[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
Responses
Acknowledgement of Receipt
Questions and Answers
Request for Additional Info

Janna

[Author]

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