NCCIH Clinical Research Toolbox

The National Centre for Complimentary and Integrative Health (NCCIH) Clinical Research Toolbox is a one‑stop, web‑based information repository for investigators and study teams conducting NCCIH‑funded clinical research. It is designed to help clinical investigators apply NIH and NCCIH requirements in a consistent way across study planning, start‑up and conduct.

Content and materials available: 

• Templates and sample forms for study documentation: Protocol Templates, NIH/FDA Phase 2 and 3 Protocol Templates, Data and Safety Monitoring Plans and
• Independent Monitoring Plan Template and over 30 sample forms for patient safety, monitoring, informed consent, medical history, quality management, regulatory checklist, training lot, etc.
• Policies, FAQs and guidance documents related to NCCIH‑funded clinical research, all relevant policies for NCCIH/NIH grants involving human subject research, reporting process for Serious Adverse Events, data and safety monitoring of clinical trials, etc.), milestone templates to transition from planning to implementation, etc.
• Additional training and recruitment resources, with links to relevant NIH web pages

Several linked pages within the Toolbox provide more detailed guidance on specific aspects of oversight and compliance. These include:

• Clinical Study Oversight Levels (differentiated requirements based on study risk and NCCIH designation)
• Regulated Products and Devices: additional requirements and the NCCIH Regulatory Tracking Form for FDA‑ or DEA‑regulated products and devices (IND, IDE, controlled substances)
• Data and safety monitoring expectations, including recommendations for independent monitoring arrangements

The Toolbox is organised as a set of topic‑based sections with left‑hand navigation, and many resources are provided as downloadable Word or PDF files for direct use or local adaptation. It is accessible from the “Resources for Researchers” area of the NCCIH website and sits alongside other NCCIH guidance on clinical trials, funding opportunities and natural product integrity.

For investigator‑initiated clinical studies, particularly those seeking or holding NCCIH/NIH funding, the Toolbox is useful because it translates high‑level NIH and NCCIH policies into concrete, ready‑to‑use documents and checklists, reducing administrative burden during protocol development, study start‑up, monitoring and reporting.