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​​​​​​​​ Protocol Review FAQ
  • Where can I submit a CROMS Quality Crosswalk Review request?


    Please click here to submit a CROMS Quality Crosswalk Review request.


  • What makes a CROMS Quality Crosswalk Review request ineligible for review?
    • Low resource grant-funded protocols are not eligible for review
    • Protocols that have already been implemented are not eligible for review (i.e., ‘Active’)

  • What documents are required for a CROMS Quality Crosswalk Review?

    Review Type

    Required Documents

    First Review

           Protocol (< v1.0)

           Informed Consent(s)

            Investigational Brochure/Package Insert

    Second Review

            Protocol (≥ v1.0)

            Informed Consent(s)

            Investigational Brochure/Package Insert

    Can include but not required:

           MOPs, CRFs, DCFs, Study Product Accountability Logs, and/or Pharmacy worksheets or forms


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


    If the Site Monitoring Team identifies a discrepancy within a required document during review, the Site Monitoring team will contact the requestor and DMID OCRA and request a corrected document and/or clarification. Once the item is clarified and the new document provided if necessary, Site Monitoring will start the review process.


  • When should I expect to hear back regarding the CROMS Quality Crosswalk Review request?


    For Type I Reviews, the completed review is provided to the requestor by the 7th business day after the request is submitted, by 5:00 PM ET. For Type II Reviews, the completed review is provided to the requestor by the 10th business day after the request is submitted, by 5:00 PM ET. However, the duration may be less or more per agreement between the requestor and DMID OCRA.

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