1. OpenLogistica A Sample Tracking Add-on to OpenClinica Jonathan Babbage Clinical & Translational Sciences Institute Biomedical Research Informatics Core 6/21/2013 OpenClinica Global Conference

2. Who we are Tools Clinical Research Management Systems Document Management I2B2 Skills Development Data Management Study Design Services Hourly Rates Percent Effort Co-Investigator Clients CDC Ohio National Guard Epidemiology Osteopathic Medicine Education

3. Journey Homebrew

4. Where we are going Adapting Observational Studies to Clinical Trial standards Training investigators on differences – Consistent protocol across subject classes – Strict CRF change standards – Adverse event tracking Expanding OpenClinica for study needs – PHI, Granulated permissions, Samples, etc.

5. What do we bring? What do we leave behind?

6. Sample Profile Who When What

7. Who

8. When Manage All Event Definitions in Study Default Study Logistica

9. What New Functionality

10. All Together Consent Form

11. Can we print yet? 56YG P1-039338-6 Consent Form Enrollment Study Name

12. Barcode Templates

13. Template Items 56YG P1-039338-6 Consent Form Enrollment

14. Can we print yet? 56YG P1-039338-6 Consent Form Enrollment Study Name

15. Barcode Templates

16. Can we print yet? 56YG P1-039338-6 Consent Form Enrollment Study Name

17. Adding Subjects

18. Creating Samples Create Samples

19. Sample Generation

20. Review Sample Profile Who, When, What Barcode Template Main record in determining how printing happens Label stock, Template items, Associated samples Template Items Set the individual data elements that are shown on a template Associated Samples Set the template the should be used for sample types Generate Samples Create the records for all samples defined in the profile

21. The Next Question Who When What Where

22. Sample Sets

23. 00002 LIMS

24. Set Logistics Obtain Samples Add to Set Prepare Shipment Receive Shipment Create samples Set collected date Define status Update status Set ship date Notify receiving lab Lock sample status Lock set contents Update sample to received Update set to received Import manifest into LIMS Looking for feedback search sets, unique set, set operations, outside interfaces

25. Current SOAP Access to necessary OpenClinica Data Authentication through existing OpenClinica login Two changes JSP pages linking to logistics components Additional SOAP services (subject group classes) Future Expand set logistics tools Default reports Interface integration Q1 2014 Source release

26. Questions/Feedback babbagej@msu.edu