67  RECIST & Tumor Assessment

67.1 What is RECIST?

Response Evaluation Criteria in Solid Tumors. Defines objective tumor response categories: - CR: Complete Response - PR: Partial Response - SD: Stable Disease - PD: Progressive Disease

67.2 CRA Oversight

• Verify imaging dates align with visit windows
• Confirm measurements trace to source imaging
• Ensure central review processes followed

67.3 High-Risk Areas

• Missed imaging windows
• Incorrect target lesion selection
• Missing baseline scans