Study Monitoring and Progress Reporting

Study Monitoring

NIH-defined clinical trials are required to provide a Data and Safety Monitoring Plan (DSMP) with the application or proposal. See the NIH Grants Policy Statement and the NIH How to Apply – Application Guide for further information on data and safety monitoring. 

For additional questions regarding the monitoring of your study and NIH Institute, Center, or Office (ICO)-specific requirements, see the NIH Data and Safety Monitoring information page or contact your Program Officer (PO).

Event Reporting

Investigators are responsible for knowing and adhering to:

• HHS human subjects regulations and event reporting requirements (see 45 CFR 46; 2007 and 2022 guidance from the Office for Human Research Protections (OHRP))
• NIH reporting requirements in the NIH Grants Policy Statement
• NIH ICO specific procedures and guidance for Data and Safety Monitoring
• Policies of the reviewing IRB (or single IRB of record for multi-site studies)
• Institutional policies
• Other requirements, such as FDA regulations at 21 CFR Parts 50 & 56, when applicable

Adverse events, including serious adverse events, must be reported to the IRB and the NIH ICO per the relevant IRB policies and funding ICO guidelines. If applicable, adverse events must also be reported to the individual(s) or group (such as an independent monitor or Data and Safety Monitoring Board (DSMB)) identified as the monitoring entity in the data and safety monitoring plan. When relevant, adverse events need to be reported toor other government agencies such as FDA and OHRP within the timelines established by the agency. The timeline for reporting adverse events is commensurate with the severity of the event.

The following reportable events, including unanticipated problems involving risks to participants or others, serious noncompliance, continuing noncompliance, and suspension or termination of IRB approval must be reported to appropriate institutional officials, the IRB, and the NIH. The institution must submit incident reports of reportable events to the Office of Human Research Protections (OHRP). The incident report needs to include plans for corrective and preventative actions. Reportable events must be reported promptly
 

Requesting Prior NIH Approval for Changes to Human Subjects

Post-award changes pertaining to the involvement of human subjects participants, such as a change in scope, require prior NIH approval. In general, any change in research procedures in an active award that would result in an increased risk to human participants requires prior NIH approval before implementation

Seek prior NIH approval for these human subjects changes:

• An addition or change to the study design/protocol that would result in the need to change the overall human subjects designation or clinical trial designation of the grant
• The new inclusion of participant populations that are covered by additional regulatory protections under 45 CFR 46 subparts B, C or D (pregnant women, human fetuses, and neonates; prisoners; or children)
• Any change to the study protocol that would result in an overall increase in risk level for participants, including physical, psychological, financial, legal or other risks.
• New information that becomes available after a study is underway which indicates a higher level of risk to participants than previously recognized for a study intervention, procedure, or pharmacological treatment.

Prior approval requests must be submitted through the eRA Prior Approval Module. See the NIH Notice NOT-OD-26-026 and eRA Commons online help, Prior Approval – Other Request, for more information.