Source Doumentation

• Document HIPAA/Consent visit
• Document every patient/MD conversation. Remember if it is not written down it did not happen.
• Document each treatment visit
• Document all correspondence with research base

Consent Timeframe

• Per ECOG there is NO timeframe. i.e., if patient signed consent ~ 1 month prior to registration
• Make sure you are using the most recent version of the informed consent.

History and Physician exam

• Complete history usually only at baseline.
• Make sure PE is "hands-on" - include Review of Systems
• Include Performance Status

Target Lesions

• Report in same order as baseline
• Name the lesions the same as baseline
• Target lesion: measurable lesion >= 2.0 cm conventional / 1.0 cm spiral method
• Al lesions reported at baseline must be reported at each F/U using same evaluation method
• Non-Target Lesion: non-measurable lesions not a target lesion (bone lesions, ascites, pleural effusion...)
• Maximum of 10 lesions can be recorded
• New lesion - off active treatment and move to LTFU

CT Scans

• If CT reports "suspicion of" or "possibility of malignancy" - this must be evaluated (biopsy) - proven to not to be malignant
• If CT report states "progression" of malignancy, patient still may not need to come off active treatment
• Progressive Disease definition

PET/CT Scans

• In order for ECOG to accept PET/CT scans for baseline, the following criteria, must be met:
  • Must be a diagnostic quality. Must be able to produce same images as a spiral CT
  • Must have IV contrast as well as po agent
  • To check if PET/CT is a diagnostic quality-contact radiologist who read the report and ask him/her to look at the films, then document his/her comments
  • Rocky Mountain PET Institute - PET/CTs are not diagnostic; use fused imaging. A spiral CT would need to be performed for patient to be eligible