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.
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.

Public reporting burden for this collection of information is estimated to average 1 minute per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to: NIH, Project Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA (0925-0648). Do not return the completed form to this address.