Download - JIC SDO Standards Development Processes
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JIC SDO Standards Development Processes
Prepared byDave Iberson-Hurst, CDISC
19th January 2010Second Draft
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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.
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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.
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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
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The Generic Process
Preliminary Project Assessment
Project Proposal
Project Approval
Develop Initial Version
Membership/Public Review
Final Approval
Publication
Maintenance
Reach Initial Consensus
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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
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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
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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.
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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
Working Draft
Enquiry
Final Vote
Publication (EN)
Maintenance
CEN Process
New Work Item Proposal
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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
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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
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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 or more different agreements for one document
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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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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.
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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
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ProjectScope
TACApproval
TeamDevelopment
TLC &ExpertReview
TLC &ExpertReview
TLCApproval
Pub. toWeb Site
Maint.
TSCApproval
WorkingGroup
Development
CommitteeBallot
FullMember
Ballot
TSCApproval
Publication Maint.
Preliminary
ProjectAssessm
ent
ProjectProposal
Project Approval
Develop
InitialVersion
Mem
bership/Public Review
FinalApproval
Publication
Maintenance
ReachInitialConsensus
ProjectScope
Statement
PWI
Approval
WorkingDraft
Committee Draft (CD)
DraftIntl
Standard(DIS)
Publication(IS)
Maint.NWIP Approval
Final DraftIntl
Standard(FDIS)
NWIPl Approval Enquiry Final Vote
Publication(EN)
Preliminary Questionnaire
Maint. Working Draft
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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.
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Where the Time is Spent
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1
1
1
1
1
?
?
Preliminary
ProjectAssessm
ent
ProjectProposal
Project Approval
Develop
InitialVersion
Mem
bership/Public Review
FinalApproval
Publication
Maintenance
ReachInitialConsensus
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?
?
2
2
?
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2
2
3
5
1
?
12
12
12
512 ?
N
N
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?
?
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Where the Time is Spent - Questions
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1
1
1
1
1
?
?
Preliminary
ProjectAssessm
ent
ProjectProposal
Project Approval
Develop
InitialVersion
Mem
bership/Public Review
FinalApproval
Publication
Maintenance
ReachInitialConsensus
12
?
?
2
2
?
11
2
2
3
5
1
?
12
12
12
512 ?
N
N
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?
?
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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