CDE/Data Policies/CDUS

• Common Data Elements (CDE) Dictionary (MS Word)
• NCI Clinical Trials Cooperative Group Program Data Sharing Policy (MS Word)
• NCI Clinical Trials Cooperative Group Program Data Sharing Policy (PDF)
• Data and Safety Monitoring (DSM) Plans
• NCI Cooperative Group Data Monitoring Committee Policy (MS Word)
• 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)
• 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)