Clinical Study Oversight Levels

The National Center for Complementary and Integrative Health (NCCIH) is committed to providing stewardship to maintain excellence, integrity, and rigor in our supported clinical studies. We apply the following five guiding principles:

Follow National Institutes of Health (NIH) Federal requirements* for human subject protections, good clinical practice, and scientific rigor
Minimize risks to participants
Maximize success, scientific potential, and impact of funded work to enhance the likelihood of publication in high-impact journals
Ensure good stewardship of government funds
Maximize productivity and relevance of NCCIH programs

The NCCIH clinical research portfolio is diverse, spanning many disciplines, conditions, and study designs. The studies may involve behavioral, device, drug, or natural product interventions. We also fund a wide range of approaches from basic/mechanistic to “real world” studies using data from health care systems.

NCCIH has defined different oversight levels to operationalize risk-based monitoring of our clinical studies based on consideration of a variety of study characteristics.

For grants considered for funding, the NCCIH program directors in the Division of Extramural Research will communicate with the principal investigator(s) following the release of the summary statement about the determined oversight level. Collaborative discussions with NCCIH will generally cover the proposed study aims, design elements, analytic plans, recruitment, retention, and risks to participants. Communications between NCCIH and potential grantees are summarized in a Request for Clarifications Letter.

*Following are the governing laws, regulations, and/or policy for clinical trials: Public Law 93-348, 12 Jul 1974; Public Law 105-115, Section 113, 21 Nov 1997; Public Law 110-85, Section 801, 27 Sep 2007; 42 CFR Part 11; 42 CFR Part 46; NOT-CA-15-011; 81 FR 64922; WMA Declaration of Helsinki, as amended; HHS Belmont Report 1979.

Oversight Levels

The NCCIH Request for Clarifications Letter will specify the oversight level, request clarification of study specific questions, and outline next steps. For specific information, choose an oversight level from the table below.

Oversight Level	Description
Exempt	Applies to studies that are exempt from NCCIH oversight.
Excluded	Applies to small, qualitative studies involving human subjects where NCCIH will not collect study documents or track accrual.
Routine	Applies to studies where NCCIH will review basic study documents prior to award.
Routine Plus	Applies to studies that propose enhanced data collection or analytic designs. A statistical review will be performed by a NCCIH biostatistician to enhance success of study implementation.
Enhanced	Applies to studies where NCCIH will review additional study documents in advance of approving enrollment to begin.
Enhanced With Site Monitoring	Applies to studies where NCCIH will review additional study documents in advance of approving enrollment to begin. These studies will also participate in the NCCIH site monitoring program with in-person or remote site visits.
Regulated Products	Applies to studies that propose the use of products regulated by the FDA and/ or DEA.
Grants With Multiple Oversight Levels	Applies to studies that contain multiple projects with at least two or more applicable oversight levels.