Toolbox Policy and Guidance

Guidance to NCCIH Investigators on Reporting Serious Adverse Events and/or Unanticipated Problems in NCCIH-Funded Clinical Studies	Provides guidance on the NCCIH reporting process for Serious Adverse Events/Unanticipated Problems
Guidance for Compliance With the NCCIH Clinical Terms of Award	Provides guidance on how to comply with the NCCIH Clinical Terms of Award.
NCCIH Clinical Terms of Award for Human Subjects Research Policy	The NCCIH policy that applies to grants involving human subject research.
NCCIH Policy on Data and Safety Monitoring	Policy 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 Awards	Provides clinical investigators with guidance on which changes to an active clinical study require prior approval by NCCIH.
NIH Policy and Guidance	NIH 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.