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. |