JIC SDO Standards Development Processes

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

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

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

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

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

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 • 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 different agreements for one document

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

14. 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.

15. DevelopInitialVersion ReachInitialConsensus ProjectProposal PreliminaryProjectAssessment Project Approval Final Approval Publication Membership/ Public Review Maintenance TLC &ExpertReview TLC &ExpertReview ProjectScope TACApproval TLCApproval Pub. toWeb Site TeamDevelopment Maint. PreliminaryQuestionnaire WorkingDraft WorkingDraft Final Vote Publication(EN) NWIP ??? Enquiry Maint. ProjectScopeStatement WorkingGroupDevelopment Full Member Ballot TSCApproval Committee Ballot TSCApproval Publication Maint. Approval DraftIntlStandard (DIS) Final DraftIntlStandard (FDIS) WorkingDraft Committee Draft (CD) Publication(IS) PWI Approval Maint. NWIP

16. 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 • CEN and ISO total duration time for the entire process needs to be entered. CEN quotes 3 years.

18. Where the Time is Spent 12 2 2 19 N 1 1 1 12 5 ? ? 1 2 ? ? 12 2 3 21 1 1 1 1 N 12 5 ? ? ? 2 ? ? 1 DevelopInitialVersion ReachInitialConsensus ProjectProposal PreliminaryProjectAssessment Project Approval Final Approval Publication Membership/ Public Review Maintenance

19. Where the Time is Spent - Questions 12 2 2 19 N 1 1 1 12 5 ? ? 1 2 ? ? 12 2 3 21 1 1 1 1 N 12 5 ? ? ? 2 ? ? 1 DevelopInitialVersion ReachInitialConsensus ProjectProposal PreliminaryProjectAssessment Project Approval Final Approval Publication Membership/ Public Review Maintenance

20. 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