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Toolbox Policy and Guidance

Links to important policies and guidance impacting NCCIH-funded clinical studies.

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 Policy on Protocol AmendmentsProvides clinical investigators with guidance on what protocol amendments require approval by NCCIH prior to their implementation.
NIH Policy and GuidanceNIH policies and IC guidance for data and safety monitoring of clinical trials.
Data Coordinating Center (DCC) Milestone Sample Document [25KB Word file]Sample form that provides suggestions for required milestones for the DCC to transition from planning to implementation. May be modified to meet individual study needs.
Clinical Coordinating Center (CCC) Milestone Sample Document [25KB Word file]Sample form that provides suggestions for required milestones for the CCC to transition from planning to implementation. May be modified to meet individual study needs.