Technical Leadership Committee

Transcription

1 CDISC Technical Leadership Committee Team Updates CDISC Interchange, November 2009 Baltimore Strength through collaboration. As a catalyst t for productive collaboration, CDISC brings together th individuals spanning the healthcare continuum to develop global, open, consensus-based medical research data standards. 1

2 Order of Team Updates ADaM John Troxell, Merck BRIDG Julie Evans, CDISC CDASH Rhonda Facile, CDISC Glossary Pat Beers Block, FDA Healthcare Link Landen Bain, CDISC ISDPilot ChrisDecker Decker, d Wise Technologies LAB Phil Pochon, Covance ODM Sam Hume, Astra Zeneca Protocol Representation Lisa Chatterjee, Digital Infusion TDM Diane WldGSK Wold, SDTM Fred Wood, Octagon Research Solutions SEND Lou Ann Kramer, EliLilly & Company Terminology Chris Tolk, CDISC 2

3 ADaM ADaM2.1 & ADaMIG1.0 Publication targeted for December 2009 ADSL and Basic Data Structure (BDS) Additional Documents in Development Application of BDS to Time to Event Examples of Other Common Uses of BDS Third Standard Structure for Incidence Analysis Datasets (e.g. ADAE) Metadata Implementation ADaM Compliance Statistical Analysis Domain Modeling in BRIDG 3

4 BRIDG BRIDG Release ease3 published for comment 30 Oct level model with domain friendlier UMLbased model and new RIM based level. BRIDG as a Global Standard 1 st Step: CDISC Public Review and Comment Comment period open until 15 Dec nd Step: ISO Joint Initiative Committee Review, comment, vote by CDISC, HL7, and ISO 4

5 3 Layer Model Future Future 5 5

6 CDASH v. 1.0 > v. 1.1 TLC review end of Nov. CDASH Project CDASH User Guide (CDASH UG) TLC review end of Nov. CDASH ODM Machine Readable Metadata Sets 1&2 under TLC review Set 3 under development Q text to V 1.1 & Annotated CRF examples to UG SDTM CDASH Device Domains Parallel ldevelopment of basic collection fields & submission mappings and metadata. ICV end of November Target for publication Early Q210 6

7 CDISC Share Pilot in wind down phase will wrap up calls in the next couple of weeks. Report under development Initial findings BRIDG mappings are proving extremely useful Preproduction of DEs prior to loading into system will be key to ensuring quality Wiki search functions require refinement 7

8 Glossary The Glossary Team has been augmented by new members. In addition to the wizened veterans, Steve Raymond (PHT), Helle Gawrylewski (J&J), Pat Beers Block (FDA), and Art Gertel (Beardsworth), we welcome Terry Quinn (NCI EVS) and Erin Muhlbradt (NCI EVS). Accomplishments: Reviewed EVS and HITSP terms, and integrated into CDISC Glossary, as appropriate Provided feedback on above Updated Glossary & Acronyms/Abbreviations to V8 for submission to Applied Clinical Trials journal (pending) Goals: Review other glossaries prepared by stakeholders khld (eg, standards d groups, pharma affiliated organizations, references) and urge adoption of CDISC definitions. It is particularly important to have ALL CDISC teams adopt tthe Glossary. 8

9 Healthcare Link Missing in Chicago 9

10 CDISC/FDA Integrated Data Pilot Slow So going g but making progress Review of ADaM components required a lot of metadata tdt and data dt changes Reworking the define file to support value level metadata De scoped to resources 4 studies Momentarily submitting first interim package to the FDA 10

11 Lab Team Accomplishments Lab Test Names Completed two additional releases adding c. 250 new analytes Microbiology Identified SDTM harmonization and vocabulary needs Completed first round of vocabulary development with terminology team Phamacogenomics Completed revision and balloting of genetic variation message components Began review of HL7 Specimen handling as next target LAB model 11

12 XML Technologies Team Update ODM released for review XML Schema Validation for Define.xml white paper Define.xml 2 0 draft before end of year Study Design Model extension draft early next year Extensions planned for next year: ISO21090Data Type support Data Clarification Request extension Null flavors 12

13 Protocol Representation Protocol Representation Model (PRM) v1.0 released for comment (Apr Jun 2009) More than 250 comments Comments from a variety of roles Preparedresponsestoresponses comments (Jun Oct 2009) Changes to BRIDG Changes to PRM documentation Align PRM with BRIDG 3.0(Nov 2009) PRM is now the Protocol Representation subdomain in BRIDG

14 Protocol Representation (cont.) Revise PRM documentation o for BRIDG 3.0 changes (Nov Dec 2009) Publish hfinal version of PRM v1.0 10and documentation (Dec 2009) Statistics modelling ( ) Seeking input for what s next Computable eligibility criteria Protocol document template 14

15 Trial Design Model SDTM Trial Design datasets examples esin Members area of the CDISC website Best Practices for Trial Design datasets posted Best Practices for Subject Elements coming Coordination with other teams Study design in BRIDG R3 / PRM V1 Study design extension to ODM (draft) SEND study design Study design HL7 message 15

16 SDS Team and Sub Team Activities (1) SDS Team Published and posted SDTM v1.2 and SDTMIG v312 v SDTMIG v3.1.2 included in Study Data Specification. Evaluated comments received on drafts, and prioritized issues for being in scope for next version. Plans to post known errata. Change focus to work being done within subteams. SDS Subteams Oncology (Barrie Nelson) Tumor Identification, Tumor Measurements, and Tumor Response domains being reviewed by SDS Team. SDTM to BRIDG Subteam (Diane Wold): all SDTMIG domains and proposed Oncology domains have been mapped to and from BRIDG Release

17 SDS Team and Sub Team Activities (2) SDS Subteams (cont d) Devices ces(carey Smoak) Device Properties, es, Device Malfunctions, cto and Device Tracking being reviewed by Devices Subteam. Exposure (Janet Reich): Proposals under development for expanding current guidelines for representing 1) planned and actual exposure data, at both the study level and subject level, and 2) dose variations (missed, interrupted, modified). Training (Chris Tolk): Newcourse hasbeendeveloped andusedthis week for SDTM v1.2 and SDTMIG v Metadata (Carolyn Wilson, Richard Lewis): Sample data and metadata in Metadata IGhavebeenrevised revised, andigis underteam review. Questionnaires (Gary Cunningham): Proposal under development for QSCAT, QSTESTCD/QSTEST values. Involvement with Coalition Against Major Diseases (CAMD) to develop standards for questionnaires for Alzheimer s Disease. 17

18 SEND Complete Rebaseline, 20 domains SEND IG v3.0 Draft A and Controlled Terminology SEND Team restructured Core Team & Subteams: IG and CCB M.Cauley, Lilly Trial Design A. Glover, Covance Findings A.Walker, Charles River Reproductive Tox M.Brucker, Merck Controlled Term P.Zorn, ThomsonReuters Safety Pharm W.Hoffman, Elan & M.Kallman, Covance CDER SEND Pilot Mock study data to test Visualization tool (6 studies from 5 companies) This week test of end to end process By year end, receipt of real study data Visualization tool redesigned Makes use of Controlled Vocabulary Ability to search across studies (trends) Installed at NCTR 2010: Significant feedback, new domains, cross divisional interest (CVM, CBER, etc.) 18

19 Terminology Group Internal CDISC Standards Development SDTMIG V3.1.2 Microbiology (960 terms), Pharmacokinetics (300 terms), General (45 terms),lab (165 terms) Development for other CDISC Models ADaM V2.0 (23 terms) Public Review on these terms closes November 20, Terms in 1000 Production

20 PKD Foundation Terminology Group External Development Development of efficacy data dt elements and terminology for Polycystic Kidney Disease C Path CAMD Using the SDTM to map existing data for Alzheimer s RTRN Working under a CRNFA to map data from 3 large clinical cardiovascular studies FDA Disease Projects TB Cardiovascular 20 20

21 Strength through collaboration. As a catalyst t for productive collaboration, CDISC brings together th individuals spanning the healthcare continuum to develop global, open, consensus-based medical research data standards. 21