Standardized Data Sharing in a Paediatric Oncology Research Network A Proof-of-Concept Study

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1 Funded by the European Commission under FP7-HEALTH-F Grant no Standardized Data Sharing in a Paediatric Oncology Research Network A Proof-of-Concept Study Nina Hochedlinger Michael NITZLNADER, Markus FALGENHAUER, Stefan WELTE, Dieter HAYN, Lefteris KOUMAKIS, George POTAMIAS, Manolis TSIKNAKIS, Davide SARACENO, Eugenia RINALDI, Ruth LADENSTEIN, Günter SCHREIER

2 Funded by the European Commission under FP7-HEALTH-F Grant no European Network for Cancer Research in Children and Adolescents Forschungsnetzwerk: 34 Partner aus 11 Länder Portal für Kollaboration: Advanced Biomedical Collaboration Domain for ENCCA (ABCD-4-E) 2

3 Funded by the European Commission under FP7-HEALTH-F Grant no ABCD-4-E Einheitliches Pseudonymisierungskonzept ENCCA Unified Patient ID (EUPID) 3

4 Funded by the European Commission under FP7-HEALTH-F Grant no ABCD-4-E Data Management App Verknüpfung von Daten aus unterschiedlichen Quellen 4

5 Funded by the European Commission under FP7-HEALTH-F Grant no Klinische Studien Opsoclonus Myoclonus Low Risk LINES OMS Neuroblastom Leukämie High Risk HRNBL 1 2 BEACON Long Term Infusion LTI HRNBL High Risk Neuroblastoma Study Biobank-Daten 5

6 Vertikale Integration Funded by the European Commission under FP7-HEALTH-F Grant no Horizontale und vertikale Integration Verknüpfung der klinischen Studiendaten Verknüpfung mit Daten aus Biobanken Biobanken Secondary Use Leukämie Neuroblastom Horizontale Integration 6

7 Funded by the European Commission under FP7-HEALTH-F Grant no Voraussetzung für horizontale und vertikale Integration 1. Einheitliche Struktur: Operational Data Model (ODM) LINES OMS Neuroblastom Leukämie HRNBL 1 2 ODM BEACON LTI Biobank-Daten 7

8 CDISC Clinical Data Interchange Standards Consortium Operational Data Model (ODM) XML-basierter Datenstandard Austausch Archivierung Version

9 ODM Operational Data Model (ODM) Study GlobalVariables BasicDefinitions MetaDataVersion Protocol StudyEventDef FormDef ItemGroupDef ItemDef CodeList ClinicalData SubjectData StudyEventData FormData ItemGroupData ItemData SubjectData StudyEventData FormData ItemGroupData ItemData Study Metadaten über Studie und Formulare ClinicalData Studiendaten 9

10 Funded by the European Commission under FP7-HEALTH-F Grant no horizontale und vertikale Integration 1. Einheitliche Struktur: Operational Data Model (ODM) 2. Einheitliche Semantik: ENCCA Kerndatensätze HRNBL LINES 1 OMS Neuroblastom Leukämie 2 ODM Filtertool Kerndatensatz- ODM BEACON LTI Biobank-Daten Data Management App 10

11 Auszug aus ENCCA Kerndatensatz Excel Kerndatensatz für Klinische Studien Item Values Description Date of Birth Sex at birth Initial Therapy 1 = Male 2 = Female 0 = None (observation) 1 = Surgery alone 2 = Conventionale-dose Chemotherapy plus surgery 3 = Intensive multi-modality therapy 4 = Intensive multi-modality therapy plus stem cell or bone marrow transplant 6 = other 9 = unknown If date of birth cannot be provided in full, the next possible/available detail should be included 11

12 Kerndatensatz Mapping XML Kerndatensatz Mapping-Datei für klinische Studien Quelldokument Ergebnisdokument 12

13 XSLT XSLT - Extensible Stylesheet Language Transformation Transformation von XML Dateien Data Management App Kerndatensatz Mapping Datei ODM XML Quelldatei XSLT Stylesheet XSLT Prozessor ODM XML Ergebnisdatei 13

14 Data Management App Grafische Darstellung ODM-XML-Quelldatei 14

15 Data Management App XML Path Language (XPATH) Kerndatensatz-Items 15

16 Data Management App XML Path Language (XPATH) 16

17 Data Management App XML Path Language (XPATH) 17

18 Data Management App XML Path Language (XPATH) 18

19 Data Management App Transformation Form StudyEvent ItemGroup Item Kerndatensatz- Mapping-Datei Kerndatensatz JA Value- Mapping JA Change ODM-XML- Quelldatei Patientenliste NEIN Copy Kerndatensatz EUPID NEIN JA SubjectData Selected JA Pseudonym NEIN Copy Warnings Pseudonym JA Change 19

20 Showcase ENCCA General Assembly Meeting am Jänner 2015, Brüssel Data Management App Demonstration 3 ODM XML Quelldokumente + Kerndatensatz Mapping Datei ENCCA IT Partner origin of ODM-formatted source data sets Type of Core Dataset AIT Neuroblastoma Clinical Trials Network Clinical Trial CINECA Leukaemia Clinical Trials Network Clinical Trial FORTH Biobank Biosamples 20

21 Zusammenfassung Syntaktische Interoperabilität Semantische Interoperabilität Biobanken Secondary Use Optimierung der Behandlung Verbesserte Lebensqualität Leukämie Neuroblastom 21

22 Vielen Dank Biobanken Leukämie Neuroblastom

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