Key Dates

Related Announcements

None

Issued by

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 guidelines and procedures related to the monitoring and oversight of data and safety monitoring.

NICHD expects all clinical research to be conducted with a high standard of quality that assures the research question is answered in a reliable, valid, and unbiased manner, and that the rights and welfare of human subjects are protected. Starting with competing applications or newly started protocols for January FY21, the NICHD expects investigators to utilize the newly released NICHD Data and Safety Monitoring guidelines.

Consistent with NIH policy, NICHD guidance for data and safety monitoring plans must describe procedures for the following:

1. Overall framework for data and safety monitoring and what information will be monitored.
2. Frequency of monitoring, including any plans for interim analysis and stopping rules, if applicable.
3. Ensuring compliance with the monitoring plan and requirements for reporting across study sites.
4. Frequency and means by which monitoring reports are generated and shared with the awarding IC.
5. Process by which Adverse Events (AEs), including Serious Adverse Events (SAEs) such as deaths, hospitalizations, and life threatening events and Unanticipated Problems (UPs), will be managed and reported, as required, to the IRB, the person or group responsible for monitoring, the awarding IC, the NIH Office of Biotechnology Activities, and the Food and Drug Administration.
6. Individual or group that will be responsible for trial monitoring and advising the appointing entity.
7. How the confidentiality of participant data will be protected.
8. Ensuring the overall assent and consent process for all participants including special needs populations, such as, but not limited to, children, individuals with developmental disabilities, individuals with intellectual disabilities, and vulnerable populations.
9. Management of incidental findings, such as aberrant findings on imaging scans or other assessments conducted as part of the research protocol.
10. How protocol violations will be handled by the principal investigator (PI) i.e. Protocol deviation is also used to refer to any other unplanned instance of protocol noncompliance).

All NIH-sponsored multi-site clinical trials and all NIH-defined Phase III clinical trials that pose potential risk and some single site clinical trials require DSMB oversight. A DSMB is an independent group of experts charged with reviewing study data for integrity, participant safety, study conduct and progress, and providing directives regarding study continuation, modification, and termination. Applicants will be expected to establish an independent, external DSMB (i.e., appointed by the institution) that is approved by the IRB if one is required either by NIH policy or NICHD (as required by Networks).

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 guidelines 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:

NICHD Clinical Trials
Email: NICHDTrials@mail.nih.gov