Welcome to the Webinar "Understanding The OASIS etmf Specification: An Overview For TMF RM Members

Transcription

1 Welcome to the Webinar "Understanding The OASIS etmf Specification: An Overview For TMF RM Members MODERATOR: Dee Schur OASIS SPEAKERS: Jennifer Alpert Palchak, OASIS etmf Technical Committee Co-Chair and CEO, CareLex Fran Ross, OASIS etmf Technical Committee Member and Associate Director, Paragon Solutions

2 Technical Committee Members CareLex, EMC, Forte Research Systems, Health Level 7, Mayo Clinic, NextDocs, Oracle, Paragon Solutions, Phlexglobal Ltd., Safe Biopharma Association, SterlingBio, SureClinical, University of Michigan Open processes: open to public observation & input

3 OASIS Open Leading global standards organization 600 organizations and over 5,000 members worldwide Global document management vendors such as Alfresco, EMC, Fujitsu, IBM, Microsoft, Oracle and many others are contributors and members of OASIS

4 Oracle: Why etmf Interoperability? Interoperability reduces or eliminates the problems of islands of automation. It enables business processes to flow from one application to another. Interoperability enables one system to work with another, in near real-time fashion, to share critical business information.

5 OASIS etmf TC Guiding Principles Create A Technical Standard Based on Standards Use Open Systems Approach Operating system independent Software application independent Computer language independent Remain Open Source & Independent Resource EVERY Company Has Unique Needs Allow for Flexibility to Add or Edit Org-specific metadata terms Org-specific content items Published Rules (draft) for Metadata Editing [essential!]

6 Goal of OASIS etmf Standard Seamless exchange of digital data/content between various collaborator systems Sponsor, Sponsor Partners, Auditors, Regulatory agencies Define formatting for etmf documents and records export and exchange between electronic systems Facilitate quality and compliance Maintain search, reporting, archival, and audit trail data of clinical trial documents

7 What IS the OASIS etmf Standard? A standard based upon standards for M2M interoperability (aka Data Portability) Detailed specification for application developers that serve the clinical trials industry Technical road map for data portability within systems Content model, data model, content model instance Machine code in RDF/XML Controlled vocabulary with unique identifying codes for ontology (essential to interoperability!)

8 What OASIS etmf Standard Is Not Not the introduction of a new TMF model for content organization Not a set of rules dictating the document names as viewed by users Is market driven and will be determined by Vendor applications Not restrictive regarding media types (document format) Is based on IANA standard = 1,080 MT at present Not restrictive in system approach Is conducive to off line, networked and cloud-based systems.jpeg.gif

9 CRO 1 System TMF RM terms Where Does TMF RM Fit? etmf Standard RDF/XML Code Sponsor System CRO 3 System TMF en Español TMF RM terms etmf Standard RDF/XML Code etmf Standard RDF/XML Code CRO 2 System TMF RM adapted OASIS etmf Standard Specification offers flexibility for TMF RM to be supported on a standards-based platform (mapping may be required) etmf Standard RDF/XML Code

10 etmf Standard/TMF RM Alignment Two Valuable Purposes: TMF RM taxonomy used in and by clinical opps ( end user ) etmf Standard codes, taxonomy and ontology used by vendors for software development to ensure interoperability/data portability (does not dictate end user views) OASIS etmf Standard supports TMF RM taxonomy while allowing software applications (vendors) to tailor their products to their clinical customer needs

11 How Will This Impact Me? Vendors Greatest immediate impact. Standard to implement companyspecific solutions for clinical trials industry that incorporate data portability (interoperability) Sponsors Data portability between multiple CROs/Vendors who implement Oasis etmf Standard CROs Data portability between CRO/Sponsors who use standard; could use same system for work with all sponsors in spite of vendor Sites Very limited impact. Vendor-designed permissions would enable usage.

12 etmf Committee Specification Draft Specification Draft document 40 page document with details regarding: Background on standard, Core Technology Architecture, Content Classification System, Web Standard Technology, Conformance requirements, Versioning, Rules, etc. (incomplete list!) etmf OWL file with RDF/XML code Metadata Vocabulary Spreadsheet

13 OASIS Work Product Lifecycle etmf TC start: 12/13 etmf TC: 45 days (6/24 8/8) OASIS Presentation to etmf TC 13

14 Future Implications Developing a Standard is an evolving process Need for on-going collaboration between TMF RM and OASIS etmf Standard (e.g. mapping) Future versions of Standard will be generated Education and Implementation Training will be essential upon Standard release Support changing industry needs on-going

15 How To Participate Join the OASIS etmf Standard Technical Committee: View & comment on etmf Committee Specification Draft (Zip file): Comments may be submitted by any person via the OASIS TC Comment URL:

16 Questions for Non-Technical Reviewers In reviewing the OASIS etmf Specification metadata vocab: Are terms used accurately mapped to TMF RM? If not, what needs to be fixed? Anything with terms that would create errors or compliance issues? Any terms missing? If so, which one(s) and how do they relate to other terms? Are there terms for documents which are not contained in a TMF?

17 Focus on Goal develop standard for interoperability of etmf Provide solutions, not criticisms Poor: Why is FDA specific regulation cited? Useful: Add EMA and CFDA regulations., which are applicable here. Be Specific Impactful Comments Poor: Use of specific field Digital Signature is not understood. Useful: Section 2, replace Enterprise with Electronic Focus on Your Area of Expertise

18 How To Submit A Comment 1. Subscribe to the comment list by sending a blank message to:etmf-comment-subscribe@lists.oasis-open.org 2. Confirm your subscription request by replying to the confirmation message you will receive from OASIS. Your subscription will not be complete until you respond to this message. 3. Watch your inbox for a Welcome message indicating that your subscription is now active. 4. Send your comment to: etmf-comment@lists.oasis-open.org 5. COMMENT-TAGS.html 6. Note: If you are a member of the OASIS Electronic Trial Master File (etmf) Standard TC, please post to the TC mailing list directly.

19 OASIS Links: Zip File Is Easiest ZIP distribution file (complete): For your convenience, OASIS provides a complete package of the prose document and related files in a ZIP distribution file. You can download the ZIP file here: csprd01.zip

20 Questions