NIA recently issued a policy update that provides additional guidance on compliance procedures for reporting human subjects enrollment data using NIA’s Clinical Research Operations and Management System (CROMS). We are writing to encourage you to review this guidance carefully and to contact us with questions.

The updates include:

  • Ensuring that Informed Consent Documents list NIH as one of the organizations that may review or receive copies of information in participants’ study records
  • Reporting the assigned National Clinical Trial number in CROMS within three months of assignment
  • Performing quarterly reviews of your CROMS study record(s)
  • Ensuring that final enrollment data reported in CROMS are consistent with the data reported in

NIA’s policy update also outlines the actions we may take for grants that are non-compliant. For more information, including examples of non-compliance, please visit the CROMS resource page. Thank you!

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