What to file in Artifact ‘Amendment’ (02.01.04)

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    • #3717
      Sarah Wilmschen
      Participant

      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!

    • #3732
      Janna Gonzalez
      Participant

      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

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