NICHD follows clinical research monitoring guidelines as set forth by five sources:
- NIH policy
- NICHD Data and Safety Monitoring (DSM) Policies for Extramural Clinical Trials and Clinical Research (PDF 428 KB)
- 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 provides guidelines on Clinical Trials Monitoring and Oversight: Milestone Planning (PDF 533 KB) and a NICHD Adverse Event, Unanticipated Problem, and Serious Adverse Event Reporting Policy (PDF 125 KB) for all its awardees. You can refer to this policy, the NIH policy website, and consultations with your NICHD Program Officer and Grants Management Specialist to develop appropriate data and safety monitoring procedures for a given study. 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.
Conflict of Interest
Investigators who need to establish a Data and Safety Monitoring Board (DSMB) for their NICHD-funded studies must ensure each board member is free from any conflicts of interest. Investigators can download this sample conflict of interest tool (PDF 168 KB) to use as guidance on how to collect the appropriate information from their DSMB members. This sample form is for internal use only and not meant to be submitted to NICHD.
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