1. 1 JIC SDO Standards Development Processes Prepared by Dave Iberson-Hurst, CDISC 19 th January 2010 Second Draft

2. 2 Purpose of Slide Set The purpose of the slide set is to provide an overview of the processes employed by the SDOs that constitute the JIC The slide set shows the alignment between the processes used by the SDOs and also illustrates the time taken to develop standards using the processes.

3. 3 Notes Regarding the Slide Set Each “real” slide is preceded by a slide containing information relevant to the following slide. These have been included such that this slide set can be understood without explanation from myself during the JIC meeting on the 20 January 2010 in Phoenix, AZ Also, please note, SDOs are ordered in alphabetical order based on the SDOs acronym, there is no deeper meaning intended IHTSDO has not been included at this time due to time constraints.

4. 4 Note for Slide “The Generic Process” This is based on the document “An overview of SDO processes and processes for common / harmonized standards development (Normative Standards). DRAFT FOR COMMENT. Version 2.1, 24 April 2008”, referred to as the JIC Process Document It represents the generic SDO development process

5. 5 The Generic Process Preliminary Project Assessment Project Proposal Project Approval Develop Initial Version Membership/Public Review Final Approval Publication Maintenance Reach Initial Consensus

6. 6 Note for Slide “CDISC Process” TAC = Technical Advisory Board – A subset of the elected CDISC board members who provide oversight of the technical work undertaken by CDISC TLC = Technical Leadership Committee – Consists of the Team Lead of each CDISC technical teams CDISC does not have an equivalent of the Preliminary Project Assessment Information sourced from the CDISC document COP- 001 Standards Development The idea for each of the SDO slides is to map to the generic process so that differences become apparent and visible

7. 7 Preliminary Project Assessment Project Proposal Project Approval Develop Initial Version Membership/Public Review Final Approval Publication Maintenance Reach Initial Consensus Project Scope TAC Approval Team Development TLC & Expert Review Public Review TLC Approval Publish to Web Site Maintenance CDISC Process

8. 8 Note for Slide “CEN Process” Information presented in based on the JIC process document and a slide presentation from the CEN web site: “Getting Started... How to develop a European Standard” by Ashok Ganesh There is a gap on the project approval stage (marked by “???”). Needs to be filled in.

9. 9 Preliminary Project Assessment Project Proposal Project Approval Develop Initial Version Membership/Public Review Final Approval Publication Maintenance Reach Initial Consensus Preliminary Questionnaire New Work Item approval Working Draft Enquiry Final Vote Publication (EN) Maintenance CEN Process New Work Item Proposal

10. 10 Note for Slide “HL7 Process” Based on the JIC process document and personal experience. Therefore probably needs checking! TSC = Technical Steering Committee HL7 does not have an equivalent of the Preliminary Project Assessment

11. 11 Preliminary Project Assessment Project Proposal Project Approval Develop Initial Version Membership/Public Review Final Approval Publication Maintenance Reach Initial Consensus Project Scope Statement TSC Approval Working Group Development Committee Ballot Full Member Ballot TSC Approval Publication Maintenance HL7 Process

12. 12 Note for Slide “ISO Process” Based on the JIC process document and the ISO web site page “Stages of the development of International Standards”, – http://www.iso.org/iso/standards_development/processes_and_procedures/stages_description.htm http://www.iso.org/iso/standards_development/processes_and_procedures/stages_description.htm ISO stages of development are the default process – Each TC operates with any number of agreements which effects document timeline and number of ballots – Depending on the document, level there may be 2 or more different agreements for one document

13. 13 Preliminary Project Assessment Project Proposal Project Approval Develop Initial Version Membership/Public Review Final Approval Publication Maintenance Reach Initial Consensus Preliminary Work Item Approval Working Draft Committee Draft Draft International Standard Final Draft International Standard Publication (IS) Maintenance ISO Process New Work Item Proposal

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15. 15 Note for Slide “Alignment” The previous slides show each SDO’s process aligned with the generic one. It allows for aspects of the process to be highlighted. The next side puts all of the processes along side each other to allow for a simple comparison to be made.

16. 16 Preliminary Project Assessment Project Proposal Project Approval Develop Initial Version Membership/Public Review Final Approval Publication Maintenance Reach Initial Consensus User Requirements Project Proposal Business Requirements Gathering Standards Development Architecture Reviews Gen Spec Change Notice Post to Web Annual Maintenance GS1 Process Call To Action

17. 17 Project Scope TAC Approval Team Development TLC & Expert Review TLC Approval Pub. to Web Site Maint. TSC Approval Working Group Development Committee Ballot Full Member Ballot TSC Approval PublicationMaint. Preliminary Project Assessment Project Proposal Project Approval Develop Initial Version Membership/ Public Review Final Approval PublicationMaintenanceReach Initial Consensus Project Scope Statement PWI Approval Working Draft Committee Draft (CD) Draft Intl Standard (DIS) Publication (IS) Maint. NWIP Approval Final Draft Intl Standard (FDIS) NWIPl Approval Enquiry Final Vote Publication (EN) Preliminary Questionnaire Maint. Working Draft

18. 18 Note for Slide “Where the Time is Spent” Slide This slide is to show where the relative effort is The circles represent months of elapsed time Assumes that a technical standard takes 12 months to write but obviously this could vary widely depending on complexity and other factors Where two colours are used the darker colour indicates the minimum time for the activity with the lighter colour being used to indicate that the activity might well take longer depending on the complexity of the standard, number of comments received etc. Symbols – The small clock icon indicates that the activity has time constraints such as review cycles (must start at the beginning of a cycle or can only be completed at a F2F meeting). This is important as this can have major impact on timelines (e.g. An NWIP can only be approved at a F2F ISO TC 215 meeting, is that true?) – The small question mark indicates an optional stage. – The small diamond used in place of the circles indicates that the stage is usually a few days in duration – Black circle with an “N” indicates that the stage is Not Applicable to that SDO Slide is not complete, needs extra info on stage durations and also I think some of the stages have time/cycle constraints (ISO & CEN NWIP/ballots happening around F2F meetings) Does not, currently, take into account the HL7 DSTU status, which can be 2 years. CEN and ISO total duration time for the entire process needs to be entered. CEN quotes 3 years. ISO has 3 tracks, 2, 3 and 4 years.

19. 19 Where the Time is Spent 1 1 1 1 1 1 ? ? Preliminary Project Assessment Project Proposal Project Approval Develop Initial Version Membership/ Public Review Final Approval PublicationMaintenanceReach Initial Consensus 12 ? ? 2 2 ? 1 2 2 3 5 1 ? 1 2 5 ? N N 19 ? ? 21

20. 20 Where the Time is Spent - Questions 1 1 1 1 1 1 ? ? Preliminary Project Assessment Project Proposal Project Approval Develop Initial Version Membership/ Public Review Final Approval PublicationMaintenanceReach Initial Consensus 12 ? ? 2 2 ? 1 2 2 3 5 1 ? 1 2 5 ? N N 19 ? ? 21

21. JIC Alignment Having worked through the above we see the SDO’s processes in “isolation” Further issues can arise when JIC tries to co- ordinated work across SDOs such as: – Alignment of ballots/review – Documentation format issues – Others? It may be worth doing some work trying to assess these impacts and describing them on a slide