Download - ODM-based Study Archival
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ODM-based Study Archival
Jozef AertsXML4Pharma
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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
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Topics
Practical use of ODM for archival of clinical studies
Advantages / Disadvantages
Electronic Signatures
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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 ?
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Wayne's experiences
200+ active studies 3500+ legacy CDMS archives Spanning 15 years
Options Formatted ASCII files SAS XPT CDISC ODM
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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
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Study ArchivalAdvantages of CDISC ODM
Data + metadata Full audit trail 21 CFR 11 compliant File linking: “chains” of files
Special features => vendor extensions
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Study ArchivalAdvantages of CDISC ODM
XML is very well searchable(XPath, XQuery)
Native (or mixed) XML databases
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Study ArchivalDisadvantages 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”
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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
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Alternative formatsSAS XPT
Legacy format Many limitations Very limited set of metadata SAS software necessary Audit trails !
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Alternative formatsPDF
Interesting for (e)CRFs Metadata ? Audit trails
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Electronic Signaturesand 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
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XML-Signature for ODM