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