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Because of a lapse in Government funding, the information on this website may not be up to date, transactions submitted via the website may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted.

The NIH Clinical Center (the research hospital of NIH) is open. For more details about its operating status, please visit cc.nih.gov.

Updates regarding Government operating status and resumption of normal operations can be found at OPM.gov.

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National Center for Complementary and Integrative Health

Toolbox Policy and Guidance

Guidance to NCCIH Investigators on Reporting Serious Adverse Events and/or Unanticipated Problems in NCCIH-Funded Clinical StudiesProvides guidance on the NCCIH reporting process for Serious Adverse Events/Unanticipated Problems
Guidance for Compliance With the NCCIH Clinical Terms of AwardProvides guidance on how to comply with the NCCIH Clinical Terms of Award.
NCCIH Clinical Terms of Award for Human Subjects Research PolicyThe NCCIH policy that applies to grants involving human subject research.
NCCIH Policy on Data and Safety MonitoringPolicy for establishing system of appropriate oversight and monitoring of the conduct of NCCIH-supported clinical research.
NCCIH Policy on Natural Product Integrity Provides information and a link to NCCIH Policy on Natural Product Integrity.
NCCIH Guidance on Changes to Clinical Studies in Active AwardsProvides clinical investigators with guidance on which changes to an active clinical study require prior approval by NCCIH.
NIH Policy and GuidanceNIH policies and IC guidance for data and safety monitoring of clinical trials.
Milestones Template for UG3-UH3 [36KB Word file]Sample template for required milestones to transition from planning to implementation. May be modified as needed.
Milestones Template for UG3-UH3 With Independent Clinical Coordinating Center (CCC) and Data Coordinating Center (DCC) [38KB Word file]Sample template for required milestones for the CCC and DCC to transition from planning to implementation. May be modified as needed.