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