Investigators are strongly encouraged to consult with NIAMS, at NIAMSclinicaltrials@mail.nih.gov, prior to submitting an application to any of the NIAMS clinical funding opportunities (NOFOs). Consultation prior to submission of an application allows the Program Officer to discuss with the investigator the extent to which the potential project fits with NIAMS program priorities.

In the pre-submission consultation phase, applicants will be informed if the proposal does not meet the goals and mission of the NIAMS. NIAMS reserves the right to determine that support for clinical trials may be directed through other available mechanisms supported by the NIAMS.

NIAMS staff will:

  • Consider whether the proposed clinical project meets the goals and mission of the Institute.
  • Consider whether it is appropriate for an investigator-initiated application.

NIAMS staff will NOT:

  • Evaluate the technical and scientific merit of the proposal. Technical and scientific merit will be determined during peer review.

Consultation Preparation

Investigators who anticipate submitting an application to any of the NIAMS clinical NOFOs should consider the items below in preparation for a pre-submission consultation with a NIAMS Program Officer:

  • Anticipated date of submission.
  • Study title.
  • Study PI(s).
  • Primary institution and potential collaborating sites.
  • Brief description of the objectives of the clinical study.
  • Brief rationale for the proposed clinical study.
    • Scientific basis.
    • Clinical significance.
  • Total cost estimate of the clinical study, by year.
  • Estimated start date and duration of the clinical study.

Total cost estimate of the clinical study, by year. Estimated start date and duration of the clinical study.

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