NIDCR Oversight & Related Templates

Overview

The National Institute of Dental and Craniofacial Research (NIDCR) independently assesses each NIDCR-funded clinical study for oversight and monitoring needs. It has established the following oversight mechanisms to ensure the safety of participants, the validity and integrity of the data, the appropriate conduct of the study, and the availability of data in a timely manner. As listed below, the level of oversight assigned to each study varies, depending on the risk to the human subjects and the complexity of the study.

Investigators and sponsors hold the responsibility to protect the rights and welfare of human subjects. Responsibilities include carrying out sound ethical research consistent with research plans approved by the Institutional Review Board (IRB) and in accordance with the applicable code(s) of federal regulations and Good Clinical Practice (GCP).

NIDCR Intramural Oversight & Related Templates

Intramural Principal Investigator & NIDCR-DIR Office of the Clinical Director Oversight

All NIDCR-Division of Intramural Research (DIR) investigators conducting clinical research must provide proper safety oversight of research participants and study conduct in accordance with GCP. Study teams must follow the internal NIDCR DIR Quality Management Plan (QMP), which includes reporting to NIDCR’s Office of the Clinical Director. Depending on the risk and complexity, NIDCR-supported clinical research conducted intramurally may also be subject to independent clinical site monitoring requirements.

NIDCR-Appointed Data & Safety Monitoring Committee (DSMC)

In addition to investigator responsibilities for safety oversight, study conduct and following the NIDCR Quality Management Plan, NIDCR or other sponsor may appoint an independent DSMC for interventional and certain observational studies, depending on the risk and complexity. The responsibility of the DSMC is to provide oversight related to study safety and data integrity, and to provide recommendations to the NIDCR Clinical Director. All DIR clinical research studies with DSMC oversight are subject to independent clinical site monitoring requirements.

NIDCR Extramural Oversight & Related Templates

Principal Investigator and Program Official Oversight

All NIDCR-funded investigators conducting clinical research must provide proper safety oversight of research participants and study conduct in accordance with Good Clinical Practice. Study teams must follow their internal quality assurance plan to assess the conduct of the study and the integrity of the data. The recipient is responsible for ensuring compliance with all policies under the NIH Grants Policy Statement and Terms of Award and all other applicable human subjects requirements.

NIDCR-Appointed Data and Safety Monitoring Board (DSMB)

NIDCR may appoint a DSMB for studies involving an intervention. The DSMB is an independent group of experts who have the primary responsibilities to 1) periodically evaluate the accumulating study data for participant safety, study conduct and progress, and when appropriate, efficacy, and 2) make recommendations to NIDCR concerning the continuation, modification, or termination of the study. All NIDCR studies with DSMB oversight are subject to independent clinical site monitoring requirements through the NIDCR Clinical Research Operations and Management Support contract.
 

NIDCR-Appointed Clinical Study Oversight Committee (CSOC)

NIDCR may appoint a CSOC for observational studies. The CSOC is an independent group of experts who have the primary responsibilities to 1) periodically evaluate the accumulating study data for participant safety, study conduct and progress, and 2) make recommendations to NIDCR concerning the continuation, modification, or termination of the study. All NIDCR studies with CSOC oversight are subject to independent clinical site monitoring requirements through the NIDCR Clinical Research Operations and Management Support contract.

NIDCR Medical Monitor

The NIDCR Medical Monitor oversight process is appropriate for clinical studies deemed as needing additional oversight but not requiring a Safety Committee. Generally, Principal Investigators will submit a report to the NIDCR Medical Monitor at specified intervals. This report will include enrollment and retention data, cumulative listings of adverse events, serious adverse events, unanticipated problems and protocol deviations, data on disposition of biospecimens, outcome measures, and other relevant parameters.

NIDCR-Appointed Independent Safety Monitor

NIDCR may appoint a qualified clinician with relevant expertise whose primary responsibility is to provide independent safety monitoring. This is accomplished by evaluation of safety data with follow-up through resolution or stabilization. The Independent Safety Monitor (ISM) evaluates individual participant and cumulative safety data when making recommendations regarding continuation of the study.

Recipient Institution-Appointed Oversight Body

In some instances, NIDCR may accept an independent oversight body appointed and managed by the recipient institution. NIDCR will require reports, minutes, and recommendations generated from this type of oversight and may request additional reporting using NIDCR-specified templates.

Additional Resources

• Clinical Research - Office of Science Policy