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Establishment of Health Level 7 (HL7) Standard for Submission of XML Stability Data

Establishment of Health Level 7 (HL7) Standard for Submission of XML Stability Data. Norman R. Gregory Chemist Division of Manufacturing Technologies. http://www.hl7.org. Background. Stability Data a major component of quality submissions

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Establishment of Health Level 7 (HL7) Standard for Submission of XML Stability Data

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  1. Establishment of Health Level 7 (HL7) Standard for Submission of XML Stability Data Norman R. Gregory Chemist Division of Manufacturing Technologies http://www.hl7.org

  2. Background • Stability Data a major component of quality submissions • Included in human pharmaceuticals, animal drugs, medical devices • Original submissions, amendments, supplements and annual reports • Included in tens of thousands of submissions annually

  3. Where effort fits in Department, Agency and Center Goals • Identification, development and maintenance of data standards • Effective data transport standards • Targeting drug development and clinical trials processes and for drug safety surveillance

  4. Alternative strategies explored • Special format developed during U. of Maryland generic drug database project • PDF • SAS Transport

  5. Data characteristics • Intrinsically hierarchical in nature • Updates of studies over time • Emergence of xml provided opportunity to capture data effectively

  6. Importance of HL7 as standard • Based on xml • Already established as standard for other submissions, including Structured Product Labeling

  7. What Is HL7? • "Level Seven" refers to the highest level of the International Organization for Standardization (ISO) communications model for Open Systems Interconnection (OSI) • The HL7 organization was founded in 1987 • In June 1994 HL7 was designated as an ANSI accredited standards development organization (SDO)

  8. HL7 Mission Statement HL7 provides standards for interoperability that improve care delivery, optimize workflow, reduce ambiguity and enhance knowledge transfer among all of our stakeholders, including healthcare providers, government agencies, the vendor community, fellow SDOs and patients. In all of our processes we exhibit timeliness, scientific rigor and technical expertise without compromising transparency, accountability, practicality, or our willingness to put the needs of our stakeholders first.

  9. HL7 Activities • Develop & publish ANSI certified specifications • Promote the use of the standards • Provide education • Provide conformance certification services • Provide methodologies for extending standard • Encourage usage of HL7 world wide • Collaborate with developers of healthcare and information technology standards in leveraging our respective skills, knowledge and standards

  10. Who is HL7? • About 470 organizational members • About 1000 total members • Up to 500 attend the Working Group Meetings • 35 International affiliates in: • Argentina – Austria • Australia – Brazil • Canada – Chile • China – Columbia • Croatia – Czech Republic • Finland – France • Germany – Greece • Hong Kong – India • Ireland – Italy • Japan – Korea • Luxembourg – Netherlands • New Zealand – Norway • Pakistan – Romania • Russia – Singapore • Spain – Sweden • Switzerland – Taiwan – Turkey – United Kingdom • Uruguay

  11. History of Stability Standard • January 2001 - Development of HL7 Stability Standard started • January 2005 - Stability Standard (R1) passes HL7 Committee ballot • May 2005 - Stability Standard (R1) passes HL7 Membership ballot • September 2005 - HL7 Stability Standard (R1) is ANSI approved and 1st public draft of Implementation Guide

  12. History of Stability Standard (Cont.) • September 2006 -Kick-Off meeting for the Product Stability Data Pilot • May 2006 - Published FR notice (Docket No. 2006N-0181 (Product Stability; Data: Notice of Pilot)) • May 2008 - Product Stability Data Pilot Project Completion Announcement (http://www.fda.gov/oc/datacouncil/stability.html) • January 2009 - Stability Standard (R2) as Draft Standard for Trial Use (DSTU) and Implementation Guide Pass ballot

  13. History of Stability Standard (Cont.) • May 2010 - Stability Standard (R2) as Normative Pass ballot • May 2010 - Style Sheet developed • October 2010 - Stability Standard (R2) Implementation Guide Pass ballot • November 2010 - Started Schematron (business rules) development • January 2011 - Started validation procedures document

  14. Goals To standardize the way stability data is transferred electronically. • Company Company • Contractor Company • Company Regulatory Agency

  15. How • Model is developed describing the process using Visio • Model is converted to XML Schema • Viewers are developed to view XML in desired format

  16. Model (R2)

  17. XML Schema (segment) maxOccurs="1"/>      </xs:sequence>       <xs:attributeGroup  ref="InfrastructureRootAttributes"/>       <xs:attribute  name="typeCode"  type="ActRelationshipHasComponent"  use="optional"  default="COMP"/>    </xs:complexType>     <xs:complexType  name="PORT_MT090001UV01.Component2">       <xs:sequence>         <xs:group  ref="InfrastructureRootElements"/>         <xs:element  name="pauseQuantity"  type="PQ"  minOccurs="1"  maxOccurs="1"/>         <xs:choice>           <xs:element  name="storage"  type="PORT_MT090001UV01.Storage"  nillable="true"  minOccurs="1"  maxOccurs="1"/>           <xs:element  name="testing"  type="PORT_MT090001UV01.Testing"  nillable="true"  minOccurs="1"  maxOccurs="1"/>        </xs:choice>      </xs:sequence>       <xs:attributeGroup  ref="InfrastructureRootAttributes"/>       <xs:attribute  name="typeCode"  type="ActRelationshipHasComponent"  use="optional"  default="COMP"/>    </xs:complexType>     <xs:complexType  name="PORT_MT090001UV01.Component3">       <xs:sequence>         <xs:group  ref="InfrastructureRootElements"/>         <xs:element  name="test"  type="PORT_MT090001UV01.Test"  nillable="true"  minOccurs="1"  maxOccurs="1"/>      </xs:sequence>       <xs:attributeGroup  ref="InfrastructureRootAttributes"/>       <xs:attribute  name="typeCode"  type="ActRelationshipHasComponent"  use="optional"  default="COMP"/>    </xs:complexType>     <xs:complexType  name="PORT_MT090001UV01.Component4">       <xs:sequence>         <xs:group  ref="InfrastructureRootElements"/>

  18. Working Group • Conducted preliminary tests • Included actual stability data from approved submissions • Focused on data viewers • Authoring tools • Revised standard and implementation guide • Submitted revision to HL7 as Release 2 • Business rules and validation

  19. Your Involvement • Participate and/or stay informed by joining the rcrimstability list server (http://www.hl7.org/listservice/index.cfm)

  20. Sample Viewer prior to HL7 Standard

  21. A Graphing Tool included in One Company’s Viewer

  22. Style Sheet developed by WG

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