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​​​ Protocol Development FAQ
  • ​How do you submit a protocol amendment to CROMS for the Document Library?​


    Pl​ease submit your revised protocol to SIO@dmidcroms.com. Please also attach or list the revisions/change summary and CROMS will initiate the review process within N-CRMS to note the changes.​​​​​​​​​​​​


  • What if an error is discovered in a document provided?

    ​​​​​​​​​​​​​​​
    If the Study Information Office (SIO) identifies a discrepancy within a required document during review, the SIO team will contact the Clinical Project Manager (CPM) for the study and request a corrected document. Once provided, SIO will upload the corrected document(s) to the document library.


  • What can I do to prevent protocol document discrepancies?


    Ensure the document has a version date and a version number if applicable. If submitting a clean protocol document, ensure there are no tracked changes present.​​​​​​​​​​​​​​​


  • How is the amended protocol updated to the ClinicalTrials.gov website?

    ​​​​​​​​​​​​​​​
    After reviewing the revisions/change summary, CROMS will initiate the review process within N-CRMS to note the changes. The updates will then be sent to the NLM ( ​  ClinicalTrials.gov​​​)​​​​ after review.


  • Who do I contact for questions, concerns, or access regarding the Document Library?


    Please contact DMID-CROMS IT Support.​​​