1. Pediatric Oncology Data Collection in Multi-Center Studies Pediatric Oncology Networked Database (POND) International Outreach Program International Outreach Program St. Jude Children’s Research Hospital

2. POND Pediatric Oncology Networked Database www.pond4kids.org

3. POND4Kids.org Objective: Compare clinical research data at multiple sites. Features: –Web-based data collection –Multiple sites – each with local control on who can enter, share and view data –Customized Quick Entry Forms –Multilingual User Interface –Online Reports and Data Exports –Provided at no cost to partner hospitals

4. Patient Registration Page

5. Locating a Specific Patient Record: Modes - Browse, Search

6. The Patient Summary Page Diagnosed Cancers “Standard” Clinical Forms Customized “Quickforms”

7. Treatment Summary Page

8. Laboratory Summary Page

9. Laboratory Data Page

10. Menus and Data Entry Timestamps in 24hr International format Calculated values

11. Cancer Diagnosis - Appropriate class codes, staging, histologies are presented via “pull-down” for each cancer type As with all pull down terms, these histologies are translated Repeating fields; Create as many as required

12. Patient Status Detail Note different second-level fields due to different “Patient Status” selection

13. Custom QuickForms – Data Entry

14. Quickforms Builder - As introduced earlier, Quickforms offers an expedient means to enter or view data normally entered or viewed in multiple individual forms. Using the utility depicted below, Quickforms may be easily created and modified. All necessary data dependencies are automatically enforced. For example, if a lab value is requested, the required timestamp information will be tied to it.

15. Quickforms - As with Protocols, Quickforms may be shared to the global POND community. Sharing QuickForm Templates

16. Quickforms Manager - Quickforms may be modified, activated, deactivated, deleted, copied and shared globally.

17. Drug Database - Drugs names are translated and maintained in the centralized POND database in order to avoid confusion between local, common, generic, and proprietary nomenclature. Drugs are also categorized based upon normal usage. Drug Database

18. Cancers Database - Similarly, common cancer nomenclature is maintained in the central POND database. Reference is made to the standardized ICD coding systems.

19. Protocol Builder - Protocols may be developed by any Site admin. completed protocols may then be employed locally or optionally shared to the global POND Protocol Library Protocol Builder

20. Protocol Builder - Utilizing the online tool, Protocols are constructed action-by-action. An action may be the administration of a drug, a lab test, an examination, or any other action taken on behalf of a patient. Drug dosage formulas may be included which will then auto-calculate recommended dosages based upon an individual patient’s current vital signs information.

21. Protocol Manager - Protocols may be modified, activated, deactivated, deleted, copied and shared globally. Activated protocols may never be modified, but may be copied and modified as a revision.

22. Data Access Controls

23. Inter-Site Data Sharing - Based upon various criteria such as disease group, or patient. All data is access is controlled by local Site Admin. Sharing Data Between Sites

24. Sharing Data with other POND Users

25. Online Reports

26. Excel Exports Data Exports

27. Reporting on Protocols

28. Survival reports

29. … complete with graph

30. Toxicity reports (optionally broken by protocol cycle)

31. Sharing Data within AHOPCA Data Management Infrastructure Sharing Data within AHOPCA Costa Rica Panamá El Salvador Nicaragua Honduras Guatemala Hodgkin lymphoma Local data entry Local queries PI queries PI reports AHOPCA WebMISPHO McMaster Nutrition Epidemiology POND

32. POND Summary Secure storage of clinical research data User maintains control of the data Flexible data sharing Easy-to-use web-based technology Multilingual ability Global access via the internet

33. POND – Current Users The Central American Pediatric Hematology/Oncology Association (AHOPCA): Guatemala, El Salvador, Honduras, Costa Rica, Nicaragua, Panama, Dominican Republic Mexico - Culiacan, Guadalajara Paraguay Morocco

34. POND Future Development Users are the primary source of requests for additional features As new features are added, they appear immediately (even while logged on) Enhanced reporting options, support for hematology patients, and improved data integrity functions are the focus of development for the first quarter of 2005

35. POND Requirements Any computer that has an internet connection Any internet browser: Internet Explorer 5.0 or higher, Mozilla, Opera, Mac, etc. Use of the most recent version of the chosen browser is recommended

36. POND Cost Free Limited technical support

37. To Learn More www.pond4kids.org Yuri Quintana, PhD Informatics and Education Director, Yuri.Quintana@stjude.org Scott Howard, MD, MS Director of Clinical Trials, Scott.Howard@stjude.org International Outreach Program St. Jude Children’s Research Hospitalhttp://www.stjude.org/international

38. POGO M MISPHOCollaborators