X Site anonymization computer Need tracking software at

X Site anonymization computer Need tracking software at each site for work-list 1 LIDC Message System: Development for Phase 1 implementation 12 Secure transfer in-house to LIDC computer SSH or secure FTP for transfer, with a script developed as required A All 4 reads must be received (and at end of unblinded reviews, reconciled) by computer A 6 Other Subject data fields Linked to case Image send of 1 to computers B, C, D, E 11 10 2 Possible NCI based status display program 13 3 1 (All colors) Denotes tasks to be developed and integrated 3, 4, 5, 6 (Gray) Denotes Blinded Review tasks 7, 8, 9, 10 (Yellow) Denotes Un. Blinded review tasks XML Reading Response Message, With Contour file and review data, Sent back only to sending site, computer A, for each case 5 7 XML Reading Assignment message sent to computers B, C. D, E) 9 4 8 Marking tools must be available for each computer for radiologist marking B, C, D, E Remote “other site” computers Return to Overview Slide

1. Anonymization • • Such as the U. Michigan software Anonymize – Scrub certain fields – Set others to NULL • See Process Model 2. 4 for details Return to Overview Slide

2. Broadcast Anonymized Image data • In DICOM format • Using rsync or other mechanism Return to Overview Slide

3. Initial Reading Assignment XML Message (First Blinded Review) • • In specified message format With specified message content • • • Coded to Identify as Blinded Review Case id Reader id Etc. Broadcast to Sites B, C, D, E Return to Overview Slide

4. Blinded Review - Marking Tool • Assigned reader at each site (B, C, D, E) uses review and marking software – – • Creates Boundaries for Nodules > =3 mm Marks centroid for Nodules < 3 mm Marks centroid for Non-Nodules > =3 mm Labels each object (Nodule or Non-Nodule) as described in Process Model 2. 4 Software converts boundaries from internal format to LIDC TG-2 specified format in XML Return to Overview Slide

5. Blinded Review Response XML Message • • In specified message format With specified message content • • Coded to Identify as Blinded Case id, Reader id Boundary data also in specified XML format Radiologist Reading CDEs (Labelings, etc. ) Return to Overview Slide

6. Receive Blinded Reviews • Receive Reviews at Originating Site At end of Blinded review • • • Store Individual Reads in local (Level 1) d. B Create p. Map? ? Merge the required number (4) of remote site reviews to create XML file with composite reviews Return to Overview Slide

7. Unblinded Reading Assignment XML Message • When all required (4) Blinded Reviews have been received and compiled, then Send Unblinded Reading Assignment Message: • • • In specified message format With specified message content • • • Coded to Identify as Un. Blinded Review Case id Reader id Etc. Transmit Composite Blinded Review Data (created in Step 6) as part of message Broadcast to Sites B, C, D, E Return to Overview Slide

8. Unblinded Review - Marking Tool • Assigned reader at each site (B, C, D, E) uses review and marking software Each Reader sees all markings of all readers (anonymized) Each Reader sees their own markings uniquely distinguished Each Reader Creates their own Unblinded Review by Editing their Blinded Review results • • • – – • Accepting or Rejecting Their own Markings Accepting or Rejecting the Markings of Others Allow Editing of Boundaries Allow Editing of Object Labeling (or Labeling of new objects) Software converts boundaries from internal format to LIDC TG-2 specified format in XML Return to Overview Slide

9. Un. Blinded Review Response XML Message • • In specified message format With specified message content • • Coded to Identify as Un. Blinded Case id, Reader id Boundary data in specified XML format Radiologist Reading CDEs (Labelings, etc. ) Return to Overview Slide

10. Receive Un. Blinded Reviews • Receive Reviews at Originating Site At end of Un. Blinded review • • • Store Individual Un. Blinded Reads in local (Level 1) d. B Perform reconciliation. Create p. Map Return to Overview Slide

11. Other Subject Data • At other points in time, Site A may enter other data that will be linked to case or nodule: – Pathology (of an individual nodule) – Ethnicity – Smoking History • To be entered at Local (Level 1) database Return to Overview Slide

12. Monitoring • Software needed at each site to Monitor and help manage: – Each case submitted (by Site A), to track • • Reader Assignments Completion Status – Each Reader (at Site A), to track • • • Case assignments Assignment Type (Blinded/Unblinded) Completion Status Return to Overview Slide

13. Possible NCI Based Status Reporting • • Centralized location to which all messages are sent Status of all cases centrally displayed Return to Overview Slide