2016 Technical Update. August 2016

Transcription

1 2016 Technical Update August

2 Foundational Standards Key Milestones CTR ODM XML Modernize CT Process CDISC Protocol Standards IntraChange Cross-team focus Survey CTR Content Governance: Consistent model for streamlined governance Project focused teams Glossary v8 CDISC Validation Rules Project Description CTR-ODM XML Clinical Trial Repository (CTR) standard in Operational Data Model (ODM) XML format IntraChange Introduce a cross-team collaboration focus to the IntraChange meeting Gain feedback on the approach through participant survey Governance Develop a standard governance model and framework to provide nimble oversight of CDISC standards, processes and systems Update COP-001 Evaluate formal standards update strategy CDISC Protocol Standards Develop and deliver protocol concepts to support the CTR standard and the TransCelerate Biopharma Common Protocol Template (CPT) Develop Protocol-XML standard Modernize CT process Modernize the controlled terminology process to deliver efficiency improvements and embrace newer CDISC technology Evaluate new technology and an integration with SHARE Introduce Transparency to the new term request process Glossary v8 Update the CDISC glossary with new biomarker terms to support FDA/NIH Biomarker Development Initiative Project Focused teams and processes CDISC Validation Rules Update Foundational Standards to support CDISC Healthcare Link Cross-teamcollaboration on shared, consolidated goals aligned with the Roadmap Discuss and agree on the principles of validation. Identify and fix known issues Define a framework for continued development

3 Q117 Q217 Q317 Q417 Foundational Standards Key Milestones Modernize CT (Part 2) ODM-XML v2.0 Foundational Standards Team Integration Healthcare & Research link Publishing Strategy Governance: Roll out governance model Governance: Versioning Strategy Principles for Standards Development Project Description ODM-XML v2.0 Publishing Strategy Clinical Trial Repository (CTR) standard in Operational Data Model (ODM) XML format Updated to support wearable data Separate normative and informative content Establish a comprehensiveexamples registry Align SDTMIG & SENDIG on strategy Governance Rollout the revised governance model, and revise as necessary Evaluate versioning strategies Variable, Domain Annual Update/Release cycle Foundational Team Integration Forge closer operating model for foundational standards teams CDASH & SDTM Team Merger Modernize CT process Healthcare & Research link Principles for Standards Development Modernize the controlled terminology process to deliver efficiency improvements and embrace newer CDISC technology Evaluate new technology and an integration with SHARE Introduce Transparency to the new term request process Update Foundational Standards to support CDISC Healthcare Link LOINC update Discuss and agree on the principles of validation. Identify and fix known issues Define a framework for continued development

4 CDASH Model & IG v2 SENDIG v3.1 Foundational Standards Delivery Plan SEND-DART v1 SDTM v1.5 SDTM v1.6 SDTMIG v3.3 Batch 3 SDTMIG v3.3 SDTMIG-MD v2 ADaMIG v1.1 ADaM OCCDS SDTMIG v3.2 Conformance ADaMIG v1.2 ADaM IDS v1 Define-XML v2.1 CTR-XML ODM Mobile Extension Protocol-XML Define-XML UG CT Package 25 CT Package 26 CT Package 27 CT Package 28 New Term Request System QRS Supplements (x4) QRS Supplements (x4) QRS Supplements (x4) QRS Supplements (x4)

5 CFAST TA Standards Key Milestones TA Modules in SHARE CDISC Protocol Elements for Prostate Cancer Diabetic Kidney Disease, Rheumatoid Arthritis, Major Depressive Disease, CV Imaging, Prostate Cancer, Kidney Transplant, Colorectal Cancer, Malaria, Ebola and Vaccines (n=10) Survey IntraChange Cross- Team Approach Governance: Consistent model for streamlined governance Project focused teams E2E or B2E Begin to develop complete research standards, including Foundational, Therapeutic Area (TA) augmentations and Controlled Terminology from Protocol through SDTM/ADaM. Project Description SHARE Use SHARE tools to build TA standards from the start, re-using prior TAs;; Prostate Cancer is the first use case. TLC F2F TAUG Updates Modularize and update published TA standards IntraChange Introduce a cross-team collaboration focus to the IntraChange meeting Gain feedback on the approach through participant survey Governance Develop a standard governance model and framework to provide nimble oversight of CDISC standards, processes and systems Update COP-001 Develop Escalation Policy FDA Specifications Oncology Program Develop specifications for the FDA Technical Conformance Guide. Initiate 1-2 Oncology Therapeutic Areas Protocol & Prostate Cancer Develop a limited number of protocol endpoints as part of the Prostate Cancer project Project Focused teams and processes Cross-teamcollaboration on shared, consolidated goals aligned with the Roadmap

6 Program Status Chart 22* published TA standards to date 13 ongoing projects + updates (13) and TA Specs *Includes v2s Planned starts in 2016: Duchenne MD Huntington s Disease, Lung Cancer, HIV, CDAD - pending funding 6

7 Leverage new branding Key Milestones surveys & Listening TCs;; document results Awareness event Manuscript CDISC Strategy Session International Interchanges (April, June, September), CFAST TA Workshops, CDISC Intrachanges(March, August) Increase Education Courses (classroom and online) and webinars Project Description Webinars 3 members only and 2 public webinars completed 9 members only and 9 public scheduled Classroom/ online courses Authorized Instructors $58k ahead of budgeted income for YTD 15 authorized classroom courses available Private training requests up 300% over Q1 avg. 4 Public course events completed, 12 scheduled 62 online course modules published 12 TA courses in development, 6 planned 11 Foundational courses/updates in progress, 10 planned 42 authorized instructors Based in 7 countries across North America, Europe, Asia 9 training languages Branding Leverage Unlock Cures branding to reach new patient advocacy foundations, academia, clinicians through new marketing materials (brochures, updated website, videos) Surveys & Listening Tours Develop a white paper and presentation with summary of listening tours with pharmaceutical companies and member survey to be utilized to understand difficulties with implementation and the landscape of end to end standards Events 3 March -Cowboy Up raising funds for PTSD March - Intrachange & TA Workshop April European Interchange Vienna 1-2 June Japan Interchange Tokyo September International Interchange - MD CDISC Strategy Session 2 August 70 invited representatives from govt, academia, nonprofit, pharma to discuss CDISC sustainability

8 Healthcare Link Key Milestones Healthcare Link Key Milestones esource Stakeholders Group ACC registry project readout HCL Conceptual Revisioning Hackathon HCL Courses Project Description esource Stakeholders Group Multi-stakeholder group working with FDA to produce implementation guide for esource ACC registry project Single site (Duke) proof of concept study to test feasibility an usefulness of CDISC standards in registry work esource Sponsor Projects CDISC partnership with biopharma/device/med center sponsors to demonstrate benefits of using esource for regulated research HCL Conceptual Revisioning Revising Healthcare Link to update for next 5 years approach to healthcare Review and update of HCL standards Revise coursework Hold conceptual hackathon to inspire ideas HCL Connections Develop connections to SHARE to demonstrate ecrf capabilities Develop strategy for mobile to lay groundwork for using mobile with esource / ODM Explore connections to Learning Healthcare System to demonstrate use of HCL in feedback learning loop for healthcare

9 SHARE Key Milestones API v1.0 Complete Public Demo SHARE Business Model eshare/api Pilot Survey API v1.0 Release Process for Biomedical Concepts SHARE CDISC Standards Model v2.0 Support E2C and esource Projects (see Healthcare Link) Support Modular Publication of TA Spec and User Guides UML & RDF Grant Submission Q2 Project Updates API Developmen t & Release API Pilot Metrics SHARE Business Model SHARE Application Programming Interface (API) Beta release: April 4 Interchange API Showcases April 27 & September 27 Production API release 2016 Developing utility and usability. Summary data to be published. Drafting plan to gather use cases & requirements for prioritized communitydriven development Draft structures for API cost models created License cost re-negotiations ongoing with vendor on which cost recovery estimates will be based Process for Biomedical Concepts Creation SHARE Model 2.0 Support E2C & esource of Healthcare Link Support TA Spec and User Guides Roles, Processes documented Pilot designed Grant submitted to support work Major enhancem ent over 1.0 ISO classes, rules, biomedical concepts, codelist subsets, improved support for TAs & ADaM SHARE team participation in esource Meeting March 18 Early strategizing with Healthcare Links team on X-Path, DEX and FHIR 90% of TA Specification derived from SHARE Managing and reusing metadata using SHARE tools Examples & rules repository development in progress

10 Q117 Q217 Q317 Q417 SHARE Key Milestones Collaboration w/ NCI on MDR RFP Awarded RFP SHARE API 2.0 Design NCI MDR Migration Assessment Go/No-Go SHARE API 2.0 Implementation Pilots for Biomedical Concepts Submission SHARE on FHIR Support E2C and esource Projects (see Healthcare Link) Support Publication of Standards Development and Guides 2017 Project Milestone Descriptions CDISC Resource NCI MDR NCI cadsr MDR Modernization RFP Release: Q217 MDR Customization & Build: Q217-Q317 Assessment for CDISC SHARE Migration to NCI MDR: Impacts, Migration Planning & Resource Allocations API 2.0 Design API 2.0 Implementati on Architect API 2.0 to expose rules, biomedical concepts, subsets, and other new features Include JSON as new CDISC technical standard Implementation Plan: Support for API 1.0 and 2.0 for a set time period to support end users Dependencies on NCI MDR product availability, post-deployment assessment and migration planning Process for Biomedical Concepts Creation SHARE on FHIR Support E2C & esource of Healthcare Link Support TA Spec and User Guides Pilots from clinical element models and donated concepts from member organizations Create resource or profile mapping SHARE metadata to HL7 FHIR resources, with input from Healthcare Link & esource initiatives on priority SHARE team participation in esource FHIR discussions Strategizing with Healthcare Links team on X- Path, DEX and FHIR Continue rolling out metadata capture templates to teams Identify and fill metadata gaps with teams to improve consistency & quality Examples & rules repository in active use