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.
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