Measurability consistency and accuracy of the measurement. □ Feasible, will do □ Feasible, will not do Conversely, if artifacts or attachments are present but the radiologist □ Not feasible is confident and prepared to edit the contour to eliminate the impact, then the tumor need not be judged non-conformant to the Profile. □ Routinely do already Consistency Shall confirm that the tumor is similar in both timepoints in terms of □ Feasible, will do with Baseline all the above parameters. □ Feasible, will not do □ Not feasible Image Analysis (section 3.9) □ Routinely do already Reading Shall re-process the first time point if it was processed by a different □ Feasible, will do Paradigm Image Analysis Tool or Radiologist. □ Feasible, will not do □ Not feasible □ Routinely do already Result □ Feasible, will do Shall review & approve margin contours produced by the tool. Verification □ Feasible, will not do □ Not feasible Physicist Checklist Note: The role of the Physicist actor may be played by an in-house medical physicist, a physics consultant or other staff (such as vendor service or specialists) qualified to perform the validations described. Physicist(s) Checked: Conforms Parameter Requirement Site Opinion (Y/N) Periodic QA (section 3.5) □ Routinely do already Shall perform relevant quality control procedures as □ Feasible, will do QC recommended by the manufacturer. □ Feasible, will not do Shall record the date/time of QC procedures for auditing. □ Not feasible Protocol Design (section 3.6.2) Shall validate that the protocol achieves an f50 value that is □ Routinely do already In-plane between 0.3 mm-1 and 0.75 mm-1. □ Feasible, will do Spatial □ Feasible, will not do Resolution See section 4.1. Assessment Procedure: In-plane Spatial □ Not feasible Resolution Shall validate that the protocol achieves: □ Routinely do already □ Feasible, will do Voxel Noise a standard deviation that is < 60HU. □ Feasible, will not do
Measurability consistency and accuracy of the measurement. Conversely, if artifacts or attachments are present but the radiologist is confident and prepared to edit the contour to eliminate the impact, then the tumor need not be judged non-conformant to the Profile. □ Feasible, will do □ Feasible, will not do □ Not feasible Consistency with Baseline Shall confirm that the tumor is similar in both timepoints in terms of all the above parameters. □ Routinely do already □ Feasible, will do □ Feasible, will not do □ Not feasible Image Analysis (section 3.9) Reading Paradigm Shall re-process the first time point if it was processed by a different Image Analysis Tool or Radiologist. □ Routinely do already □ Feasible, will do □ Feasible, will not do □ Not feasible Result Verification Shall review & approve margin contours produced by the tool. □ Routinely do already □ Feasible, will do □ Feasible, will not do □ Not feasible Physicist Checklist Note: The role of the Physicist actor may be played by an in-house medical physicist, a physics consultant or other staff (such as vendor service or specialists) qualified to perform the validations described. Physicist(s) Checked: Parameter Conforms (Y/N) Requirement Site Opinion Periodic QA (section 3.5) QC Shall perform relevant quality control procedures as recommended by the manufacturer. Shall record the date/time of QC procedures for auditing. □ Routinely do already □ Feasible, will do □ Feasible, will not do □ Not feasible Protocol Design (section 3.6.2) In-plane Spatial Resolution Shall validate that the protocol achieves an f50 value that is between 0.3 mm-1 and 0.75 mm-1. See section 4.1. Assessment Procedure: In-plane Spatial Resolution □ Routinely do already □ Feasible, will do □ Feasible, will not do □ Not feasible Voxel Noise Shall validate that the protocol achieves: a standard deviation that is < 60HU. □ Routinely do already □ Feasible, will do □ Feasible, will not do