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NICHD Policy for Data & Safety Monitoring

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The 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; and
  • If applicable, relevant U.S. Food and Drug Administration (FDA) regulations.

In addition, given the scope of NICHD's research and the various populations studied and served, the NICHD has further refined clinical research monitoring guidelines to provide a more uniform structure for all of its awardees in support of research efforts.

The NICHD Clinical Research Monitoring Policy Guidance Document (PDF - 202 KB) explains the details of NICHD guidelines on monitoring along with additional supporting information.

The NICHD also provides a sample charter for the Independent Data Monitoring Committees (PDF - 168 KB) for Institute-supported studies.

For more information on clinical research monitoring, please visit http://www.nichd.nih.gov/health/clinicalresearch/steps/pages/conduct_monitor.aspx.

Last Updated Date: 11/30/2012
Last Reviewed Date: 11/30/2012

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