Conducting Clinical Research | NIDCR

NIDCR supports a variety of clinical research, including interventional and observational studies, to advance fundamental knowledge about dental, oral, and craniofacial (DOC) health and disease.

NIDCR's Oversight Determination Process

After a project has been selected for funding, NIDCR reviews the specific aims to determine the level of oversight needed during the planning, activation, and completion of the research project. Please contact your NIDCR Program Official or the Office of the Clinical Director to confirm NIDCR's level of oversight for each study within your project. 

Planning & Activation Process

For studies subject to additional NIDCR oversight, NIDCR will request specified study documents. At a minimum, a study protocol using the NIDCR protocol template, a Data and Safety Monitoring Plan, and the study Informed Consent document are expected. Compliance with developing other documents (e.g., study plans, case report forms) and completion of certain start-up activities (e.g., database development, NIDCR-appointed independent oversight board review) prior to starting human subjects research may also be expected. 

Contact your NIDCR Program Official or the Office of the Clinical Director for guidance on which tools and templates are applicable for your study.

Overview

Once a project is launched, the study should be conducted with high quality standards and follow Good Clinical Practice guidelines. NIDCR-funded human subject studies should be conducted in a way that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are respected and protected throughout the study. Routine monitoring for data quality and participant safety should also occur during the study conduct stage. Below is a list of resources to maintain good study conduct.

NIDCR's Additional Oversight During Study Conduct

For studies with additional oversight, NIDCR has certain expectations throughout the life cycle of the clinical research project, which may include several of the following:

• Study teams inform the Institute of any institutional review board (IRB)-approved amendments that have been made to the protocol and consent form.
• Study operations documents (e.g., Manual of Procedures (MOP)/Standard Operating Procedures (SOP), Data Management Plan, Statistical Analysis Plan, Data and Safety Monitoring Plan) should be updated accordingly and submitted to NIDCR, as appropriate.
• Comply with requirements for prompt safety reporting to NIDCR (e.g., Serious Adverse Events, Unanticipated Problems).
• Periodic review by an independent, NIDCR-appointed oversight board (e.g., DSMB, CSOC, DSMC).
• Follow internal quality management practices as outlined in a Quality Management Plan, or similar document, and provide periodic reports to NIDCR as requested.
• Periodic review by an NIDCR-appointed Medical Monitor.
• Participate in clinical site monitoring visits and activities conducted by NIDCR's contracted Clinical Research Associate [for additional information see the Clinical Monitoring Guidelines].
• Submit routine reports to monitor study progress (e.g., enrollment reports). 

These processes are ongoing throughout the life cycle of the project.

Study teams should rigorously follow the IRB-approved protocol and MOP/SOP that were developed during study planning. For studies with additional NIDCR oversight, NIDCR expects that all updated documents should be filed within the study’s Essential Documents Binder.

Data & Safety Monitoring 

Types of Additional Oversight: NIDCR 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 human subjects and the complexity of the study. This oversight is advisory to NIDCR.

Activities During Study Closure

Proper close-out of clinical studies ensures that the appropriate regulatory and oversight bodies involved in human subjects protections are informed of study status and assists in ensuring data integrity and the validity of study outcomes. Study close-out activities should be initiated once participant enrollment and research activities (including all follow-up visits) have been completed and can consist of activities including but not limited to:

• Updating regulatory and oversight bodies of study status.
• Data clean up and electronic database lock.
• Confirming final disposition of biospecimens, investigational product, study equipment, and supplies.

NIDCR provides as a resource a study close-out checklist that outlines the specific activities that might be necessary in this stage.