Presentation Sb


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Presentation Sb

  1. 1. Registry solution
  2. 2. Introduction <ul><li>Easy and flexible data management system </li></ul><ul><li>Comprehensive data analysis and research possibilities </li></ul><ul><li>Independence, data security and privacy standards </li></ul><ul><li>Advisory board guarantees the expert leadership </li></ul>Project management Technical support Marketing <ul><li>web application – data entry </li></ul><ul><li>analytical sw tools </li></ul><ul><li>web pages </li></ul><ul><li>Help Desk </li></ul><ul><li>security </li></ul><ul><li>connectivity etc </li></ul><ul><li>contract services </li></ul><ul><li>project managing </li></ul><ul><li>CRF design </li></ul><ul><li>clinical afair management </li></ul><ul><li>budget tracking </li></ul><ul><li>wage agreement </li></ul><ul><li>brochures / leaflets </li></ul><ul><li>posters </li></ul><ul><li>graphic design </li></ul><ul><li>CI </li></ul><ul><li>interactive CD </li></ul><ul><li>promotion </li></ul>Other services <ul><li>Data analyses </li></ul><ul><li>Data entry </li></ul><ul><li>Monitoring </li></ul><ul><li>Clinical trials services </li></ul>
  3. 3. Life cycle of Project time Definition of main Aims Definition of Parameters CRF Validation of CRF (statistician) Definition of process Structure of the Registry Advisory Board Rules definition Strategy Creation of database Data collection Data management Monitoring / Reporting Statistical outputs Data analyses Presentation Publication PROJECT DEFINITION DATA COLECTION DATA ANALYSES REPEATING
  4. 4. On-line Database System
  5. 5. Basic features of the Registr y <ul><li>Patient data is entered in few minutes </li></ul><ul><li>Y ou can create data entry forms customised to the user </li></ul><ul><li>Validation and control </li></ul><ul><li>Account management , administration </li></ul><ul><li>Security , archiving </li></ul><ul><li>Data analysis and statistics </li></ul><ul><li>System modularity </li></ul><ul><li>Reporting customizable </li></ul><ul><li>email alerts </li></ul><ul><li>Help desk (phone/mail/sharing desktop technology) </li></ul>
  6. 6. Inserting data to the registry 1 2 3 4
  7. 7. Advantages of on-line solution <ul><li>Centralized system of data collection </li></ul><ul><li>Archiving system </li></ul><ul><li>Instant control ( record approval ) </li></ul><ul><li>Clear identification </li></ul><ul><li>Easy creation of parameters - indexes </li></ul><ul><li>Logical consistency </li></ul><ul><li>Validation rules </li></ul>RESULT = Less mistakes = INFORMATION QUALITY
  8. 8. Security of on-line solution <ul><li>Standard web browser (IE 5.5 or higher ) </li></ul><ul><li>HTTPS proto c ol 128 bit SSL Certifi cate ver sion 3, the same technology as in bank applications </li></ul><ul><li>Username and password – authentication </li></ul><ul><li>Username and password is verified by the server </li></ul><ul><li>Customizable rights for access to the data </li></ul><ul><li>Time-out for inactivity </li></ul><ul><li>Security and stability of ORACLE 9i database </li></ul>
  9. 9. Usage in practice – active usage of ON-LINE solution Active users
  10. 10. Pros and cons of ON-LINE solution <ul><li>ADVANTAGES </li></ul><ul><li>Users can insert new case directly via web browser from any place with internet connectivity (home, work…) </li></ul><ul><li>No need to install any local software </li></ul><ul><li>System administrator is able to add new parameter or form very easily </li></ul><ul><li>Users can see the change / new form in real time </li></ul><ul><li>DISADVANTAGES </li></ul><ul><li>No possibility to analyse data directly in the registry </li></ul><ul><li>Internet connection neccessary </li></ul><ul><li>No possibility to create presentations and graphs </li></ul>Mere internet connectivity is enough!! Data analysis not possible!!
  11. 11. Technological scheme of the System Client Computer (Secure web-based communication) 128 bit SSL New data is entered to the system using standard Web Browser (IE6) over a secure connection (SSL) . Users log in with their user name and password and the system enables them to view/edit existing episodes on the central server and add new ones. Web Server Database Server ( Oracle 9i Server) Firewall
  12. 12. Seven Bleep administration
  13. 13. Number of registered users <ul><li>Number of registered users: 19 </li></ul><ul><li>Countries </li></ul><ul><ul><li>United States: 7 users </li></ul></ul><ul><ul><li>Czech Republic: 2 users </li></ul></ul><ul><ul><li>Poland: 2 users </li></ul></ul><ul><ul><li>Canada: 1 user </li></ul></ul><ul><ul><li>France: 1 user </li></ul></ul><ul><ul><li>Israel: 1 user </li></ul></ul><ul><ul><li>Japan: 1 user </li></ul></ul><ul><ul><li>Portugal: 1 user </li></ul></ul><ul><ul><li>Spain: 1 user </li></ul></ul><ul><ul><li>Turkey: 1 user </li></ul></ul><ul><ul><li>United Kingdom: 1 user </li></ul></ul>
  14. 14. Registered centers <ul><li>Alberta Children's Hospital , Ca </li></ul><ul><li>Dep. of Ped. Anesthesiology, PICU Univ. Hosp., Brno, CR </li></ul><ul><li>Dep. of Clin. Hematol., Univ. Hosp., Brno, CR </li></ul><ul><li>Hospices Civils de Lyon, Lyon, Fr </li></ul><ul><li>Pediatric Hematology/Oncology Unit, Jerusalem, Is </li></ul><ul><li>University of Occupational and Environmental Heal, Kitakyuusyuu, Jp </li></ul><ul><li>ICU, Pediatric University Hospital, Lodz, Pl </li></ul><ul><li>Department of Pediatric Oncology & Hematology, Wroclaw, Pl </li></ul><ul><li>Hospital S. Joao Deus, V N Famalicao, Po </li></ul><ul><li>Pediatric Hematology, Hospital Universitario La Fe, Valencia, Sp </li></ul><ul><li>Ege University Hospital, Izmir, Tu </li></ul><ul><li>North Bristol NHS Trust, Frenchay Hospital, Bristol, UK </li></ul><ul><li>Pediatric Hematology and Oncology, Albuquerque, US </li></ul><ul><li>Duke University Medical Center, Durham, US </li></ul><ul><li>University of Minnesota, Minneapolis, US </li></ul><ul><li>St. Louis Regional Center for Childhood Bleeding, Missoury, US </li></ul><ul><li>Geisinger medical Center, Danville, US </li></ul>
  15. 15. Number of episodes <ul><li>Total number of episodes: 36 (6 empty) </li></ul><ul><li>Neonatal: 24 </li></ul><ul><li>Regular: 12 </li></ul>
  16. 16. Number of episodes <ul><li>Grouped by center </li></ul><ul><ul><li>Dep. of Ped. anesthesiology, PICU Univ. Hosp. Brno 8 </li></ul></ul><ul><ul><li>St. Louis Regional Center for Childhood Bleeding 22 </li></ul></ul><ul><ul><li>other centers - empty forms only </li></ul></ul><ul><li>Grouped by user </li></ul><ul><ul><li>Michal Klimovi č 8 </li></ul></ul><ul><ul><li>John Puetz 22 </li></ul></ul><ul><li>Grouped by status </li></ul><ul><ul><li>Approved 8 </li></ul></ul><ul><ul><li>Completed 22 </li></ul></ul><ul><ul><li>Pending 1 </li></ul></ul><ul><ul><li>Empty 6 </li></ul></ul>