NICHD Policy for Data & Safety Monitoring

NICHD follows clinical research monitoring guidelines as set forth by four sources:

  • NIH policy
  • Regulation through the Code of Federal Regulations (CFR) Title 45, Part 46 as it applies to federally funded research
  • Good Clinical Practice as described in Document E6 of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use
  • If applicable, relevant U.S. Food and Drug Administration (FDA) regulations

In addition, NICHD is working to further refine clinical research monitoring guidelines for all of its awardees. Updated documents will be provided  as soon as they are available. In the interim, please use the NIH policy website to develop appropriate data and safety monitoring procedures for a given study in consultation with your NICHD Program Officer and Grants Management Specialist. If you are involved in a study supported on an NICHD-supported network award, please consult the Network operating manual and NICHD network Program Officer for additional guidance.

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