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Kickoff for SDTM 1.3 Content in SHARE 2014-03-19.

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Presentation on theme: "Kickoff for SDTM 1.3 Content in SHARE 2014-03-19."— Presentation transcript:

1 Kickoff for SDTM 1.3 Content in SHARE

2 STANDARDS DEVELOPER BEWARE EXPLICIT SEMANTICS EXPLICIT RELATIONSHIPS CONNECTED METADATA BEYOND THIS POINT WARNING 2

3 Agenda Introduction Scope and approach Expectations and timelines Work plan AOB 3

4 Scope and approach (1) #R2 Milestone DescriptionDue Date 2Load SDTMIG and 3.2 May 30th 3SEND content August 29th 6ADaM contentOctober 24th 7Value Level Metadata contentNovember 14th Communication to TransCelerate Full list: wiki.cdisc.org/x/GYBDwiki.cdisc.org/x/GYBD Develop metadata interactively, i.e., using Semantics Manager Build competency today, pave MDR-driven development tomorrow (e.g., Research Concept) 4

5 Scope and approach (2) #R2 Milestone DescriptionDue Date 2Load SDTMIG and 3.2 May 30th 3SEND content August 29th 6ADaM contentOctober 24th 7Value Level Metadata contentNovember 14th 2 distinct phases: 1.3/3.1.3 and 1.4/3.2 Crawl: 1.3/3.1.3 SHARE jargons, tool onboarding, content development processes, train the trainers, wishlisting, etc. Walk: 1.4/3.2 Higher in volume, governance process, guidelines and policies, etc. 5

6 Expectations and timelines – SDTM 1.3 Mid-March to Mid-April Week 1 Kickoff meeting (1 hour) Training (1.5 hours) On-line reference (self-pace; 1 to 2 hours) Week 1/2 Hands-on practices (self-pace; 1 to 2 days) Week 3/4 Actual content development Content QC Content approvals 6

7 Work plan Early quantitative analysis of changes from SDTM v1.2: New Content Requirements: SDTM v1.3 / SDTMIG v3.1.3New Content Requirements: SDTM v1.3 / SDTMIG v3.1.3 Divide and conquer to develop? By domain? By change type (new vs. modify)? How to QC? In-steam vs. end of process? Governance approval at the end 7

8 All other business Communications Standing meeting? IM Wiki / JIRA On-line introductory materials (recommended reading before interactive tool training) 1.How to Speak SHARE-ese? (Wiki)How to Speak SHARE-ese? 2.What is ISO 11179? (CDISC Portal)What is ISO 11179? 3.Introduction to BRIDG (CDISC Portal)Introduction to BRIDG Action Items 8


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