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ODM-based Study Archival Jozef Aerts XML4Pharma. History of the work February 2008: TMF asks to write an expert opinion (Gutachten) on the use of ODM.

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Presentation on theme: "ODM-based Study Archival Jozef Aerts XML4Pharma. History of the work February 2008: TMF asks to write an expert opinion (Gutachten) on the use of ODM."— Presentation transcript:

1 ODM-based Study Archival Jozef Aerts XML4Pharma

2 History of the work February 2008: TMF asks to write an expert opinion (Gutachten) on the use of ODM for study archival June 2008: first draft February 2009: final version

3 Topics Practical use of ODM for archival of clinical studies Advantages / Disadvantages Electronic Signatures

4 Practical use of ODM for Archival Many EDC vendors archive as ODM + CRFs as PDF Only 1 extensive experience report CDISC Interchange Paris 2005: W.Kubick: Case Study: Applying CDISC Standards to replace a Legacy CDMS What are the best practices ?

5 Wayne's experiences 200+ active studies 3500+ legacy CDMS archives Spanning 15 years Options Formatted ASCII files SAS XPT CDISC ODM

6 Wayne's experiences 13 months of planning, design, building and validating tools Actual archival: 8 months (planned: 12-18) 5 staff (planned: 7) Major issues Metadata were missing Audit trail reconstruction

7 Study Archival Advantages of CDISC ODM Data + metadata Full audit trail 21 CFR 11 compliant File linking: chains of files Special features => vendor extensions

8 Study Archival Advantages of CDISC ODM XML is very well searchable (XPath, XQuery) Native (or mixed) XML databases

9 Study Archival Disadvantages of CDISC ODM File size Same data in SAS XPT has half the size When zipped: 30% difference Compression factor: ~50 Best practice: one file per subject Visual presentation is lost Use ODM ArchiveLayout

10 ODM Archival Best Practices 1 file per subject File chaining using FileOID and PreviousFileOID Metadata / ReferenceData in separate file or in each file Vendor extensions XML-Signature

11 Alternative formats SAS XPT Legacy format Many limitations Very limited set of metadata SAS software necessary Audit trails !

12 Alternative formats PDF Interesting for (e)CRFs Metadata ? Audit trails

13 Electronic Signatures and ODM XML files (but also sections of them) can be signed using XML-Signature Signature is XML itself and can reside within the XML file Uses electronic certificates New evolution: XAdES Complies to European law Extends XML-Signature

14 XML-Signature for ODM


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