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

[Author]

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