NCCIH Research Blog

New Resource on Oversight Levels for Clinical Studies; Register for December 7 Webinar

November 16, 2021

Christine Moretto Wishnoff, M.P.H

Christine Moretto Wishnoff, M.P.H.

Health Specialist

Office of Clinical and Regulatory Affairs

National Center for Complementary and Integrative Health

View biographical sketch

The National Center for Complementary and Integrative Health (NCCIH) has a helpful new resource to guide you if you are planning to submit materials required for the start of clinical studies or if you are currently funded by NCCIH to conduct a clinical study. This resource, which was designed in accordance with National Institutes of Health (NIH) initiatives to enhance stewardship of the clinical trials enterprise, is part of the NCCIH Clinical Research Toolbox, our web-based information repository for investigators and staff involved in NCCIH-funded clinical research. Register now to attend a webinar on December 7, 2021, to learn more about the oversight levels and resources available to help researchers. 

In response to advice from the extramural community and in compliance with NIH policies and guidance, NCCIH oversight has evolved from close evaluation of most NCCIH-funded clinical studies to targeted oversight. We have developed NCCIH Clinical Study Oversight Levels to guide researchers and provide clarity on the process.

Following peer review and an assessment of which grants NCCIH may fund, potential grantees will receive a Request for Clarifications letter that defines the oversight level of each proposed clinical study and includes a link to the applicable oversight level. Each oversight description details the expected study documents and the timeframe for submission, review, and NCCIH approval.

Once the decision to fund a project is made, NCCIH sends a Notice of Award (NOA), which has terms and conditions specific to your grant. It is important to carefully review and complete the requirements outlined in the NOA.

Below is the list of NCCIH oversight levels that are based on consideration of a variety of study characteristics, using a risk-based approach. More information about the levels can be found in our new resource on clinical study oversight levels.

Oversight Level or Additional Requirements

Exempt

Excluded

Routine

Routine Plus

Enhanced

Enhanced With Site Monitoring

Grants With Multiple Oversight Levels

Regulated Products*

* Regulated products will have additional requirements.

Remember that if your grant is selected for funding, the assigned NCCIH program director will be your primary guide in navigating the NCCIH oversight process.

We invite your comments on the new Clinical Study Oversight Levels. You can leave a comment below or send an email to christine.wishnoff@nih.gov.

Technical Assistance Webinar on Clinical Oversight Levels

Register now: Clinical Oversight Levels and Process Technical Assistance Webinar
December 7, 2021; 2–3 p.m. ET

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