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OnCore ®

OnCore ®. Clinical Trial Management S oftware. OnCore ®. Implemented at Wayne State University and Karmanos Cancer Center as well as numerous academic and research institutions and hospitals internationally.

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OnCore ®

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  1. OnCore® Clinical Trial Management Software

  2. OnCore® • Implemented at Wayne State University and Karmanos Cancer Center as well as numerous academic and research institutions and hospitals internationally. • Provides ability to manage all components of a clinical trial in one central location.

  3. OnCore® • Web based application that can be accessed anywhere internet access is available • Security of data is ensured through the assignment of specific roles and privileges to all study personnel

  4. OnCore® Organization:Consoles • Study Information is managed in individual consoles each of which apply to specific functions

  5. PC Console • The starting point for protocol entry to the system • Central Repository for all protocol information

  6. PC Console:Protocol Information

  7. PC console • Provides the ability to track study staff, regulatory documents and IRB information. • The next slide shows a screen shot that displays the organization of the IRB reviews and documents.

  8. PC Console:IRB Tracking

  9. CRA Console • The CRA console records all relevant information regarding the study subject and links to the protocol in the PC console

  10. CRA Console • In this console you have the ability to: • Register all new study subjects onto the study • Add the informed consent information • Determine eligibility for study participation • Place patients on study and on treatment • Verify study visits • Enter study data via data collection forms attached to the calendar and then exported to Excel or SAS.

  11. CRA Console:Register new study subjects

  12. CRA Console: Add Informed consent information

  13. CRA Console:Determine subject eligibility

  14. CRA Console:Enter and track study visitsEnter data via forms

  15. Additional Functionality • Additional consoles include those for: • Financial Management • Biospecimen tracking • Data Management • Reporting capacity both delivered reports and custom development

  16. To Use OnCore® • To request the use of OnCore® or for more information • Complete the OnCore® use request form on the MACTS web site • Email the OnCore® Coordinator at mactsoncore@med.wayne.edu • Training sessions are scheduled monthly with additional times added as needed • All personnel must be trained in the use of the software prior to access being granted

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