Protocol Development

Protocol Development Tools

• NCI Standard Protocol Language for Collaborative Agreements (MS Word)
• Cooperative Group Common Budget Outline (MS Excel)
• Policies and Guidelines for Protocol Development
• Protocol Templates and Guidelines
• Protocol Submission Worksheet v6 (MS Word)
• List of Codes and Values
  • Disease Codes
  • CTCAE Codes
  • Pre-Existing Condition Codes
  • Therapy Codes
  • Agent NSC Numbers
  • Institution Codes
• Suggested Templates for Phase 1 and 2 Clinical Trials
• Response Evaluation Criteria in Solid Tumors (RECIST) — Sites can voluntarily incorporate the new criteria and language into new protocols (Verified 2/25/20)
  • Revised RECIST Guideline (version 1.1) (PDF)
  • RECIST — Measurement of Effect Criteria (includes language for inclusion in CTEP protocols) (MS Word)
  • RECIST Article Published in EJC (PDF)
  • RECIST Article Published in JNCI (PDF)