IT Overview January 2010

Virtual Tissue Bank for Arizona Biomedical Research will provide a de-identified repository of biospecimens from AZ institutes. Data will be uploaded from the institutes into the Arizona Biospecimen Locator. Through the locator, researchers can then search and request biospecimens. Once approved by the consortium, institutes will ship and track the biospecimens. Sun Health Research Institute Public can browse information on biospecimens available for research Research staff can request biospecimens Consortium Scientific Review Committee reviews request for biospecimens Institution approves request and ships biospecimens Researcher receives biospecimens and returns unused biospecimens Arizona Biospecimen Locator (ABL): 2

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4 Phoenix Children’s caTissue DB ABRC – Arizona Biospecimen Locator St. Joesph’s Emerge.MD Tissue Locator DB (CBM Based) Tissue Locator DB (CBM Based) Arizona Biospecimen Locator CBM Grid Service Emerge.MD DB Sun Health Custom App Custom DB caTissue CBM DB CBM Grid Service ETL IdentifiedDe-identified

5 Researcher Register for an Account Researcher Search for Biospecimens Researcher Request Biospecimens Consortium Review Biospecimens Request Institution Review Biospecimens Request and Ship upon Approval Researcher Receive Biospecimens and Return upon Request of Institution

RoleFunctions ResearcherSearch, Submit Biospecimen Request, Receive Shipment, Return Biospecimen, Maintain Biospecimen Disposition Access to their own data only, view access to all biospecimens Consortium Administrator Manage Registrants, Manage Institutions Access to all Institution’s functions/data Scientific ReviewerReview Biospecimen Requests, Comment on Biospecimen Requests, Vote on Biospecimen Requests Institutional Administrator Manage Institutional Users, Manage Biospecimen Requests Access to own Institution’s functions/data only Tissue TechnicianManage Inventory, Distribute Biospecimens, Receive Returned Specimens Access to own Institution’s data only Display Price SetterSet price range to be displayed in ABL for biospecimens Invoice Price SetterSet final price for each biospecimen for requester’s invoice Super AdministratorImport Biospecimen Data Full Access to all functions/data 6

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8 Researcher Register for an Account Researcher Search for Biospecimens Researcher Request Biospecimens Consortium Review Biospecimens Request Institution Review Biospecimens Request and Ship upon Approval Researcher Receive Biospecimens and Return upon Request of Institution

9 User must register to view Biospecimen Inventory and submit requests. All registration requests are automatically approved by the system.

10 Researcher Register for an Account Researcher Search for Biospecimens Researcher Request Biospecimens Consortium Review Biospecimens Request Institution Review Biospecimens Request and Ship upon Approval Researcher Receive Biospecimens and Return upon Request of Institution

Collection Protocol Name Start Date End Date 11 Patient Demographics Ethnicity Race Gender Biospecimen Pathological Diagnosis Time Lapse to Processing Anatomic Site Biospecimen sample type Patient’s Age at Collection External ID (Record ID) Specimen Density Available Quantity Collected/Created Year Preservation Type Storage Temperature Collection Type (Surgically Resected / Autopsy) Cost Recovery Fee (Price range) Biospecimen Usage Usage Restrictions

12 NOTE: Pathological Diagnosis is standardized to use SNOMED-CT codes.

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15 Researcher Register for an Account Researcher Search for Biospecimens Researcher Request Biospecimens Consortium Review Biospecimens Request Institution Review Biospecimens Request and Ship upon Approval Researcher Receive Biospecimens and Return upon Request of Institution

16 Requester Address Name / Title Phone Research Area/Specialty Institution Name Institution Type Study Details IRB Name (required) IRB Registration Number IRB Approval Number for Study (or IRB Letter of Exemption) IRB Approval Expiration Date (unless IRB Letter of Exemption) Principal Investigator Name & Contact Principal Investigator CV Protocol Title (required) Protocol Document (optional) Study Abstract Preliminary Study? Funding Source Shipping Recipient Name & Contact Address Vendor Tracking Number Instructions Biospecimen Receipt Biospecimen Receipt Status/Quality Biospecimen Disposition

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19 Since a user other than a Researcher can submit a Biospecimen Request, we are collecting information for three people: 1.Requester 2.Principal Investigator 3.Shipment Recipient You have the option to click a checkbox saying that your contact information is the same as the Requester, and all contact information fields will be filled automatically.

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ABL Online Inventory ABL Online Inventory 22 Researcher A Select 50mg of Biospecimen A. Submit request to Consortium Select 50mg of Biospecimen A. Submit request to Consortium Researcher B Cannot find Biospecimen A in ABL Cannot find Biospecimen A in ABL Biospecimen A NOT available online Biospecimen A NOT available online Biospecimen A 100mg available online Biospecimen A 100mg available online Consortium - Scientific Review Committee Deny request from Researcher A Biospecimen A 100mg available online Biospecimen A 100mg available online Researcher B Can find 100mg of Biospecimen A in ABL Can find 100mg of Biospecimen A in ABL When any portion of a biospecimen is requested, the entire biospecimen is removed from the ABL inventory until the Consortium reviews the request.

23 Researcher Register for an Account Researcher Search for Biospecimens Researcher Request Biospecimens Consortium Review Biospecimens Request Institution Review Biospecimens Request and Ship upon Approval Researcher Receive Biospecimens and Return upon Request of Institution

Researcher Select biospecimens and create biospecimen request Consortium – Scientific Review (1 scientist from each member institution) Consortium – Scientific Review (1 scientist from each member institution) Submit Request Consortium Approves & All Institutions Approve [Wait for decision of Scientific Review Committee & Institutional Approvals] Scientist (Institution C): Vote on biospecimen request Scientist (Institution B): Vote on biospecimen request Scientist (Institution A): Vote on biospecimen request STOP Institution – Institutional Veto (1 administrator from each institution from which a biospecimen is being requested) Institution – Institutional Veto (1 administrator from each institution from which a biospecimen is being requested) Administrator (Institution C): Approve/Deny biospecimen request Administrator (Institution B): Approve/Deny biospecimen request Administrator (Institution A): Approve/Deny biospecimen request Consortium Approves & Some Institutions Approve Consortium Requests Revision Consortium Denies OR All Institutions Deny Consortium Send approval notice to Researcher with reasons Consortium Send partial approval notice to Researcher with reasons Consortium Ask Researcher to revise their request Consortium Send rejection notice to Researcher with reasons

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29 Researcher Register for an Account Researcher Search for Biospecimens Researcher Request Biospecimens Consortium Review Biospecimens Request Institution Review Biospecimens Request and Ship upon Approval Researcher Receive Biospecimens and Return upon Request of Institution

30 Each Institutional Administrator has the ability to deny a request that comes in that asks for biospecimens housed In their institution.

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Requester Name Institution Address 32 Shipment Recipient Name Address Phone Study Information IRB Approval Number of Study Shipment Request Number Date of Request Sender Name Sender Contact Information Shipping Shipping Instructions Shipping Vendor Shipping & Handling Fee Biospecimen (for each biospecimen in request) ID Number Type Pathological Diagnosis Anatomic Site Amount Recovery Fee Notes for Processing

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34 Researcher Register for an Account Researcher Search for Biospecimens Researcher Request Biospecimens Consortium Review Biospecimens Request Institution Review Biospecimens Request and Ship upon Approval Researcher Receive Biospecimens and Return upon Request of Institution

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Contact 5AM Solutions, Inc. Jungdae Kokotov – ABL Project Manager x731 39