Project Team Meeting 20 th March 2017 SDTM and ADaM Implementation FAQ Presented by CoLeads Bhavin Busa Mathew Bryant SDTM ADaM Implementation FAQ The Standards Implementation Nuances sessions at the ID: 650255
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WG: Optimizing the Use of Data StandardsProject Team Meeting20th March, 2017
SDTM and ADaM Implementation FAQ
Presented by Co-Leads
Bhavin Busa
Mathew BryantSlide2
SDTM/ADaM Implementation FAQThe Standards Implementation Nuances sessions at the Mar NA CSS and Jun EU CSS surfaced various common challenges amongst SDTM and ADaM implementers and consumersIndustry in need of a forum and subsequent knowledgebase (FAQ) to address these challenges Slide3
SDTM/ADaM Implementation FAQA working group was formed to collaborate with CDISC. Additional participants:FDASDTM/ADaM Implementation SMEsIndustryProject kick-off was in June 2016Monthly Lead Team MeetingsSub Teams meeting bi-weekly or monthlySlide4
Sub-teams SDTM/ADaM IG NuancesValidation/Conformance RulesData Submissions (SDTM and ADaM)Legacy SDTM Mapping – Recruiting LeadTrial Design DomainsTherapeutic Area Specific – Recruiting LeadIndividual Sub-Teams for each topic1 or 2 Leads, 4-6 team members
Industry, Regulatory, Standards SMEsSlide5
Process Flow:Two primary avenues will need to be developed to meet the need for user group frameworks and initial content:A process through which users can submit Question via a form on Wiki. Copy linkA Wiki database where users can go for FAQs and responses for helpful implementation information (WIP)FAQ Process FlowSlide6
Issue Clear?Issue Submitted Thru Wiki ForumOr Public events YESNoLog on Tracker
Distribute response for Project team review & discussion
Issue
Clarified
Will
Sub-Team Address?
No
Notify
Submitter
Develop Response
YES
Avenue #1
Teamwork
Avenue #1
Teamwork
Project Team Vetting?
No
Publish to FAQ
YES
Ask Submitter
for clarification
Avenue #2
Wiki
Notify
Submitter
FAQ Process Flowchart
Teamwork
FORUMSlide7
Collaboration ToolsWorking with PhUSE Wikihttp://www.phusewiki.org/wiki/index.php?title=SDTM_ADaM_Implementation_FAQWalk through project teamwork site https://phuse.teamworkpm.net/projects/157138/overviewReview SEND Implementation Wiki sitehttp://www.phusewiki.org/wiki/index.php?title=SEND_Implementation_WikiSlide8
Collected FAQs (CSS: NA and EU)Current SDTM/ADaM Implementation FAQResponse Document, working draftSlide9