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February 20, 2017

IDE Submission Tips

When submitting documentation for approval of an IDE the following TIPS are to help with the approval process.

  • Check that ALL information you submit is correct
  • Complete the CGS Submission form in its entirety.
    • Check ONLY boxes that apply.
      • Our approvals are based on what you check. For example, if you only check protocol change and the request is actually an extension along with the protocol change, we will only process the request for that protocol change.
    • Include the short name for the study only.
  • Adverse Events
    • Send in a SUMMARY of these events, not each of the forms submitted to the IRB.
  • Name your attachments accordingly.
    • Be sure you are renaming everything clearly stating the content of the document.
  • Include all documents listed on the CGS Submission form; missing information will cause a delay in the approval process.

When submitting for any type of approval there is no need to include documentation from the initial study or previous approval. CGS keeps all IDE document submissions. The above tips will help CGS move your approval requests through the process in a more timely fashion.

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