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:

  1. Follow National Institutes of Health (NIH) Federal requirements* for human subject protections, good clinical practice, and scientific rigor
  2. Minimize risks to participants
  3. Maximize success, scientific potential, and impact of funded work to enhance the likelihood of publication in high-impact journals
  4. Ensure good stewardship of government funds
  5. 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 CF4 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 or Additional Requirements Description

Exempt

Applies to studies that are exempt from NCCIH-specific 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 complex data collection or analytic design. A statistical review will be performed by an NCCIH biostatistician to enhance success of study implementation.

Enhanced

Applies to studies where NCCIH will review other study documents in addition to the basic study documents in advance of approving enrollment to begin.

Enhanced With Site Monitoring

Applies to studies where an NCCIH contractor performs a site initiation visit 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. 

Grants With Multiple Oversight Levels

Applies to clinical grants that include multiple studies with at least two or more applicable oversight levels. 

Regulated Products

Additional requirements that apply to any level of oversight for studies that propose the use of products or devices regulated by the U.S. Food and Drug Administration and/or Drug Enforcement Administration.  

 

*Basic study documents are the Study Accrual and Retention Plan and the Data and Safety Monitoring Plan.