Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Purpose

The purpose of this Guide Notice is to notify the extramural community of NICHD's policies and procedures related to the monitoring and oversight of clinical trials. As part of the NIH's efforts to enhance stewardship of clinical trials (https://grants.nih.gov/policy/clinical-trials.htm), the NICHD is enhancing its monitoring and oversight of clinical trials in several ways.

1. Milestone Plans: Starting with competing applications or newly started protocols for FY19, the NICHD expects investigators to establish a milestone plan for a given clinical trial. The milestone plan will be tailored to the specific clinical trial for which it is designed and will be composed of multiple quantitative and/or qualitative elements including but not limited to the study timeline, recruitment plans, enrollment, and other measures of progress, as appropriate to the scientific goals of the study. Investigators will work with NICHD program and grants management staff to establish and finalize the plan and reporting schedule prior to the start of the award or, in the case of delayed onset studies, prior to commencing enrollment in the trial. Step by step guidance on how to create a milestone plan and submit a report will be available at our webpage: https://www.nichd.nih.gov/grants-contracts/process-strategies/policies/clinical-research. Reports will be submitted utilizing the eRA Human Subjects System (HSS) through the eRA Commons.

2. Risk Analysis: Starting with competing applications or newly started protocols for FY19, NICHD staff will determine an institute-specific risk rating of low, medium, or high for a given trial. This assessment will consider risk to the human subjects participating in the trial as well as other factors related but not limited to the intervention, trial design, financial investment, as well as other operational considerations such as number and location of sites, experience of the investigators, status of regulatory aspects of the trial. Feedback from peer review will be factored into this assessment. This risk determination will contribute to the frequency of reporting on the milestone plan. The higher the risk, the more frequently NICHD will expect reports.

The purpose of these enhancements to monitoring and oversight of trials is to ensure that trials funded by the NICHD are successful in achieving their objectives and that the NICHD remains responsible stewards of public funds. For more information on NICHD and NIH policies and procedures related to clinical trials, please visit our webpage: https://www.nichd.nih.gov/grants-contracts/process-strategies/policies/clinical-research.

Inquiries

Please direct all inquiries to:

Caroline Signore, MD, MPH
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-496-5577
Email: [email protected]