CDE/Data Policies/CDUS/DMU

• Common Data Elements Browser
• NCI National Clinical Trials Networks Data Sharing Policy (Verified: 2/18/20) (MS Word)
• NCI National Clinical Trials Networks Data Sharing Policy (Verified: 2/18/20) (PDF)
• Policy of the National Cancer Institute for Data and Safety Monitoring of Clinical Trials (PDF)
• NIH Policy for Data and Safety Monitoring
• Further Guidance on Data and Safety Monitoring for Phase I and II Trials
• ARTICLE: Role of Independent Data-Monitoring Committees in Randomized Clinical Trials Sponsored by the National Cancer Institute (PDF) JCO, Vol 15, No 7 (July), 1997: pp 2736-2743
• Early Phase Trial Slow Accrual Guidelines (PDF)
• Slow Accrual Guidelines for Phase 3 Trials (PDF)
• Development of Slow Accrual Guidelines (PDF)
• Clinical Data Update System (CDUS)
• Data Mapping Utility (DMU)
• BOLD Task Force Common Data Elements for the collection of data in breast cancer trials:
  • How to Access the BOLD TF CDEs (PDF)
  • NCI BOLD Task Force General CDEs (PDF)
  • NCI BOLD Task Force Preoperative CDEs (PDF)
  • NCI BOLD Task Force Surgical CDEs (PDF)
  • NCI BOLD Task Force Radiation CDEs (PDF)
  • NCI BOLD Task Force Imaging CDEs (PDF)