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