1. May 2007 CTMS / Imaging Interoperability Scenarios March 2009

2. 2 Agenda History Approach Process Key Interoperability Opportunities Scenario 5 Scenario 6 Scenario 11 Scenario 12 Next Steps

3. 3 caBIG® Development History 2007 Focus Developing caBIG® compatible systems and tools Adoption and support 2008 Focus More caBIG® compatible systems and tools Knowledge Center / shared learning Understand cancer community needs for biomedical research tools, software applications, and data 2009 Focus Broad availability of structured, interoperable research data Promote a standards based business processes for clinical and translational research Further define caBIG® standards and procedures for evaluation and certification

4. 4 caBIG® Development Approach SO……. Now there is a need to focus on increasing interoperability, not just within an application suite, but across workspace domains (CTMS, Imaging, Tissue Banking, etc.) We are developing realistic workflow scenarios that span workspaces Interoperability analysis is not limited to existing tools or functionality. What would you do………..

5. 5 Process

6. DRAFT Interoperability Scenarios 1.Protocol Authoring – Coordinating Center Perspective 2.Protocol Review Tracking Process – Coordinating Center Perspective 3.Automated Lab AE Grading (Lab Viewer, caAERS and caLAEGS) 4.Study-Specific Subset of All Labs for a Subject 5.Post-Registration Specimen Collection 6.Pre-Registration Specimen Collection and Tracking 7.Get Data from EMR/EHR to CDMS 8.Management of Routine Non-Lab AEs (caAERS and CDMS) 9.Matching of Patients to Trials Based on Eligibility Criteria 10.Study Calendar Entered in PSC and Interfacing with CDMS 11.Supporting Image Based Cooperative Groups with Regard to Clinical Trials 12.Enabling Query of Patient Data Beyond DICOM

7. 7 Some Key Opportunities for Interoperability CTMS / Tissue Bank Interoperability 5.Post-Registration Specimen Collection 6.Pre-Registration Specimen Collection and Tracking 7.Get Report(s) from EHR to CDMS Imaging / CTMS Interoperability 11.Supporting Image Based Cooperative Groups with Regard to Clinical Trials 12.Enabling Query of Patient Data Beyond DICOM

8. 8 Location: CTMS KC Wiki Interoperability Scenarios – CTMS wiki https://wiki.nci.nih.gov/x/DABdAw (updated October 30, 2012) https://wiki.nci.nih.gov/x/DABdAw Interoperability Scenarios – Discussion Forum https://cabig- kc.nci.nih.gov/CTMS/forums/viewtopic.php?f=16&t=76&sid=a4a3fcb84f5c3396f8f04993724d47cb

9. 9 Post-Registration Specimen Collection Scenario: After a subject is registered to a study, a subject-specific study calendar is created in a study scheduling system. A subset of activities that will result in generation of biospecimens specifically for biobanking or correlative studies (e.g., tumor markers, etc.) will be displayed to the Clinical Research Associate (CRA). The CRA validates this information in study calendaring system and initiates a process to notify a biospecimen tracking system to enable that application to create a biospecimen collection schedule. Updates to the subject schedule for biospecimen-related activities trigger a similar updates to the biospecimen collection application. NOTE: Assuming that common Protocol information is available to all apps; These biospecimen-related activities could be part of the metadata captured during protocol abstraction, so that PSC templates can be initialized. Data Sets exchanged: Protocol data; Subject Registration; Subject calendar/schedule; Potential Tools: COPPA Services; C3PR; PSC; caTISSUE 9

10. 10 Pre-Registration Specimen Collection and Tracking Scenario: Subject is being considered for registration to a study that requires central pathology review to determine eligibility The subject signs the consent agreeing to provide the biospecimen The Clinical Research Associate (CRA) pre-registers the patient Patient receives a unique identification number, which triggers a message to the specimen tracking system Specimen tracking system initiates a specimen record with status “expected” Specimen is collected and labeled, and sent in a protocol-specific kit to a central processing lab Processing Lab processes specimen and sends the results to the Clinical Staff Subject is determined to be eligible, the CRA completes registration Data Sets Exchanged: Patient Registration, Protocol data; Biospecimen, … Potential Tools: C3PR, COPPA; caTISSUE

11. 11 Subject data from EHR to CDMS Scenario: A CRA accesses the CDMS application to search for a study subject and enter their clinical data. She selects the subject and then the appropriate Case Report Form (CRF); for example, she may select the "Surgical History" Form. The data required to complete this CRF can only be found in the Operative Report (almost always unstructured data, like a clinical note) which is typically available in the Hospital’s EMR/EHR system. The staff member requests the CDMS to retrieve a specific Operative Report from EHR based on subject id and the dates associated around it. She reviews the Operative Report and saves it in the CDMS with Personal Health Information (PHI) removed. Based on the information in this Operative Report, she completes the Surgical History CRF. NOTE: This would allow the CRA to save the source document with the CRF in an electronic fashion. Data Sets exchanged: Subject data; Subject clinical data… Potential Tools: COPPA Services; CDMS; EHR/HIS; 11

12. 12 Enabling Query of Patient Data Beyond DICOM Scenario Overview caBIG® Imaging and Clinical Trials Tools Connecting Imaging, ERCF, and Patient Registry Data For The Purpose of Enabling Query of Patient Data Beyond What DICOM Tags Provide Connecting NBIA and C3PR to Enable connection of Patient Data with Image Data in a Real Trial Can result in enhanced metadata search capability for the various collections within NBIA and across collections and for ongoing clinical trials using NBIA as an image repository Extensible to Helping Assure Patients are Matched Up with Trials Most Relevant to Them Data: DICOM Image, Patient Registration, CRF Potential Tools: NBIA, C3PR, C3D, AIM

13. 13 Supporting Image Based Cooperative Groups with Regard to Clinical Trials Scenario Overview caBIG® Imaging and Clinical Trials Tools Supporting Image Based Cooperative Groups with Regard to Clinical Trials Management caBIG® Imaging and CTMS Product Addressing Specific Challenges in Multi- Institutional Trials Extensible to Broader Clinical Trial Support (and how it can be meaningful with regard to FDA approval)… Data: DICOM Images, AIM Annotations, Patient Registration, CRF Potential Tools: XIP, caGrid, Imaging middleware, C3D, C3PR

14. Next Step: Your Input Please review of the Interoperability Scenarios and provide your feedback on content & priority by 4/3/09 Interoperability Scenarios – CTMS wiki https://cabig-kc.nci.nih.gov/CTMS/KC/index.php/CTMS/CCTS_Interoperability_Scenarios_-_Draft Interoperability Scenarios – Discussion Forum https://cabig- kc.nci.nih.gov/CTMS/forums/viewtopic.php?f=16&t=76&sid=a4a3fcb84f5c3396f8f04993724d47cb

15. Thank you!