An Overview of CDISC: A Clinical Data Standards Organization Kit Howard, MS, CCDM, CRCP CDISC, Director of Education Co-Leader Medical Device Standards Development Michael Ibara CDISC, Head of Digital Healthcare MDEpiNet Webinar, 17-Jun-2016 â CDISC 2016 Agenda ã Part - Kit Introduce CDISC and its clinical standards Where CDISC standards fit into the larger picture of standards Opportunities to leverage CDISC in MDEpiNet projects • Part - Michael Describe CDISC’s eSource initiative Introduce topic area challenges and opportunities © CDISC 2016 What is CDISC? Clinical Data Interchange Standards Consortium Non-profit Global Standards Development Organization (SDO) based in Austin, TX Founded in 1997, incorporated in 2000; over 400 member organizations Develops open and free data standards for clinical research © CDISC 2016 Pressure to Share Data is Intense: Funders Regulatory Agencies Publishers Editorials The Public Nature 522, (10 june 2015) Slide courtesy of Philippe Rocca-Serra (U of Oxford) and Paul Houston (CDISC) Pressure to Share Data is Intense: Funders Regulatory Agencies Publishers Healthcare data, Repository Data, Research Data… Editorials The Public For what? Pool, compare, reanalyze, repurpose, hypothesize, reinterpret, fish… Nature 522, (10 june 2015) Slide courtesy of Philippe Rocca-Serra (U of Oxford) and Paul Houston (CDISC) Pressure to Share Data is Intense: Funders Regulatory Agencies Publishers Healthcare data, Repository Data, Research Data… Editorials The Public For what? Pool, compare, reanalyze, repurpose, hypothesize, reinterpret, fish… Nature 522, (10 june 2015) Slide courtesy of Philippe Rocca-Serra (U of Oxford) and Paul Houston (CDISC) What we want to do? Want to save lives, improve quality of life Must be able to share data to, e.g., replicate results, access larger pools of data… BUT… it’s useless if the data aren’t fit for intended uses Clinical research data standards are part of solution © CDISC 2016 CDISC Can Help… Defined data structures optimized for research and designed for pooling • Core clinical data • Therapeutic area data • Device data including • Pre-market UDI analogue • Design to capture “in-use” settings Also supports data repository structures to pool repositories and pool with clinical research data Understands HL-7 via ISO-approved BRIDG Streamlines FDA submission production Part of determining if data are comparable © CDISC 2016 What is a Clinical Research Data Standard? A set of defined data elements, their characteristics and relationships among them Rules for creating, managing and using the data elements A design for combining data meaningfully when they have been collected in many different places and ways A best practice for managing data © CDISC 2016 CDISC in the World of Standards CONSORT ISO CEN EMA MHLW FDA ICH WHO ANSI NIH Medical Orgs CDISC TransCelerate Reagan-Udall MDIC C-Path CTTI MCC HL-7 ONC JIC MDEpiNet HITSP NLM PHIN MSSO UMLS NCVHS IHTSDO 10 Organizations of Standards Orgs CONSORT ANSI ISO CEN EMA MHLW FDA CDISC ICH WHO NIH Medical Orgs TransCelerate Reagan-Udall MDIC C-Path CTTI MCC HL-7 ONC JIC MDEpiNet HITSP NLM PHIN MSSO UMLS NCVHS IHTSDO 11 Government/Regulatory CONSORT ISO CEN EMA MHLW FDA ICH WHO ANSI NIH Medical Orgs CDISC TransCelerate Reagan-Udall MDIC C-Path CTTI MCC HL-7 ONC JIC MDEpiNet HITSP NLM PHIN MSSO UMLS NCVHS IHTSDO 12 Healthcare & Public Health CONSORT ISO CEN EMA MHLW FDA ICH WHO ANSI NIH Medical Orgs CDISC TransCelerate Reagan-Udall MDIC C-Path CTTI MCC HL-7 ONC JIC MDEpiNet HITSP NLM PHIN MSSO UMLS NCVHS IHTSDO 13 Healthcare Informatics CONSORT ISO CEN EMA MHLW FDA ICH WHO ANSI NIH Medical Orgs CDISC TransCelerate Reagan-Udall MDIC C-Path CTTI MCC HL-7 ONC JIC MDEpiNet HITSP NLM PHIN MSSO UMLS NCVHS IHTSDO 14 Dictionaries/ Terminologies CONSORT ISO CEN EMA MHLW FDA ICH WHO ANSI NIH Medical Orgs CDISC TransCelerate Reagan-Udall MDIC C-Path CTTI MCC HL-7 ONC JIC MDEpiNet HITSP NLM PHIN MSSO UMLS NCVHS IHTSDO 15 Foundations & non-profits CONSORT ISO CEN EMA MHLW FDA ICH WHO ANSI NIH Medical Orgs CDISC TransCelerate Reagan-Udall MDIC C-Path CTTI MCC HL-7 ONC JIC MDEpiNet HITSP NLM PHIN MSSO UMLS NCVHS IHTSDO 16 Operational Standards CONSORT ISO CEN EMA MHLW ANSI FDA CDISC ICH WHO TransCelerate Reagan-Udall MDIC C-Path CTTI MCC HL-7 ONC JIC MDEpiNet HITSP NIH Medical Orgs NLM PHIN MSSO UMLS NCVHS IHTSDO 17 Watchdogs CONSORT ISO CEN EMA MHLW FDA ICH WHO ANSI NIH Medical Orgs CDISC TransCelerate Reagan-Udall MDIC C-Path CTTI MCC HL-7 ONC JIC MDEpiNet HITSP NLM PHIN MSSO UMLS NCVHS IHTSDO 18 CDISC in the World of Standards CONSORT ANSI ISO CEN EMA MHLW FDA CDISC ICH WHO TransCelerate Reagan-Udall MDIC C-Path CTTI MCC HL-7 ONC JIC MDEpiNet HITSP NIH Medical Orgs NLM PHIN MSSO UMLS NCVHS IHTSDO 19 Typical Data Flow in Clinical Research Patient Care World Clinical Research World Electronic Health Records (patient data) Study Data Collection Study Protocol Data/Results Programming (study datasets/reporting) Repositories Publications Statistics (analysis datasets) Clinical Study Reports FDA (submissions) 20 CDISC Standards: Data Collection CDASH Foundational Standards ADaM Example e/CRF PRM CDASH Specifications Healthcare Systems SDTM CDASH FDA Controlled Terminology (Code Lists) CDISC’s Foundational Standards Can Help Patient Care World Clinical Research World Electronic Health Records (patient data) Study Data Collection Study Protocol Data/Results Programming (study datasets/reporting) Repositories Publications Statistics (analysis datasets) Clinical Study Reports FDA (submissions) 28 CDISC Standards: Study Datasets/ Reporting SDTM Healthcare Systems Example Reporting Data CDASH SDTM Data Comes from CDASH CDISC Standards: Study Datasets/ Reporting SDTM SDTM Dataset Specifications ADaM PRM Healthcare Systems Example Reporting Data CDASH Data Comes from CDASH SDTM CDISC Standards: Study Datasets/ Reporting SDTM SDTM Dataset Specifications ADaM PRM Example Reporting Data Healthcare Systems SDTM CDASH Controlled Terminology Data Comes from CDASH CDISC’s Foundational Standards Can Help Patient Care World Clinical Research World Electronic Health Records (patient data) Study Data Collection Study Protocol Data/Results Programming (study datasets/reporting) Repositories Publications Statistics (analysis datasets) Clinical Study Reports FDA (submissions) 32 CDISC Standards: Analysis Datasets ADaM ADaM Healthcare Systems CDASH SDTM Analysis Dataset CDISC Standards: Analysis Datasets ADaM ADaM Dataset Specifications ADaM Healthcare Systems CDASH SDTM Analysis Dataset CDISC Standards: Analysis Datasets ADaM ADaM Dataset Specifications ADaM Healthcare Systems SDTM CDASH Analysis Dataset Controlled Terminology CDISC’s Foundational Standards Can Help Patient Care World Clinical Research World Electronic Health Records (patient data) Study Data Collection Study Protocol Data/Results Programming (study datasets/reporting) Repositories Publications Statistics (analysis datasets) Clinical Study Reports FDA (submissions) 36 How we know if data are the same? Ask the Same Question Use the Same Name Use the Save in the Use Same Same Same Assumptions Answer Set Structure Data are the SAME when Assuming you ask a valid question… Foundational (Core) Standards Cover Findings Special Purpose Concomitant Medications (CM) Interventions Adverse Events (AE) Events ECG (EG) Demographics (DM) Exposure (EX) & Exposure as Collected (EC) Medical History (MH) Inclusion Exclusion Criteria (IE) Comments (CO) Procedures (PR) Disposition (DS) Lab (LB) Subject Visits (SV) Substance Use (SU) Device Events (DE) Questionnaires (QS) Subject Elements (SE) Device Exposure (DX) Healthcare Encounters (HO) Subject Device Subject Characteristics (SC) Relationship (DR) Clinical Events (CE) Death Details (DD) Device Tracking (DT) Vital Signs (VS) © CDISC 2016 Foundational Standards Implementations Patient Care World Clinical Research World Electronic Study Data Health • (General) Human Clinical Trials Collection RecordsGuide (IG) (patient data) Implementation Study Protocol • Device IG Data/Results • Therapeutic Area User Guides (UG) Programming • Major Depressive Statistics (study Disorder (analysis datasets) datasets/reporting) • Alzheimer • Diabetes • Cardiovascular Endpoints • Etc Repositories Clinical Study Reports • PGx IG • Associated Persons IG • Animal Toxicology/Reproductive Toxicology IG Publications FDA (submissions) 39 Devices IG Seven Device Domains Special Purpose Domains Interve ntions Findings Events Device Identifi ers (DI) DeviceSubject Relations hip (DR) Device Propert ies (DO) Device -In-Use (DU) Device Expos ure (DX) Device Events (DE) Trackin g and Disposi tion (DT) Consistent unique sponsordefined identifier that links data across domains Look-up table providing single consistent link between each device and subject Important unvarying device characteristic s that are not identifiers Measuremen ts and settings intentionally set that may vary between uses of a device Subject’s exposure to a medical device under study Reportable devicerelated occurrences such as malfunctions and calibrations Physical locations of device, either at each movement or just final status © CDISC 2016 Devices Covered in Device IG Class II & III requiring submission Denture Adhesive Reagents Single vs Multiple Component Drug/Device Combos Device Not Under Study Device Under Study Implantables Injectables Software Diagnostics Powered Wheelchair Dialysis Machines Subject:Device 1:1 1:Many Many:1 Many:Many National Institutes of Health/Department of Health and Human Services Image: CSF CDISC Therapy Area Standards Using Device Domains Alzheimer’s Traumatic Brain Injury Asthma Diabetes Influenza © CDISC 2016 QT Cardiac CDISC Can Help… Defined data structures optimized for research and designed for pooling • Core clinical data • Therapeutic area data • Device data including • Pre-market UDI analogue • Design to capture “in-use” settings Also supports data repository structures to pool repositories and pool with clinical research data Understands HL-7 via ISO-approved BRIDG Streamlines FDA submission production Part of determining if data are comparable © CDISC 2016 CDISC Not Specifically Designed for… EHR Data Inventory management Cost data … Can interface and store clinical trials-related data © CDISC 2016 Thank you! Informing patient care and safety through higher quality medical research Supplementary Materials © CDISC 2016 CDISC Standards (1) CDASH model • Clinical Data Acquisition Standards Harmonization model • Used to design data capture structures consistently CDASH IG • Implementation Guide for implementing CDASH model for core and custom domains • Codifies rules for capturing CDISC-conformant data SDTM model • Study Data Tabulation Model • Used to guide development of clinical and other study data structures SDTM IG • Study Data Tabulation Model Implementation Guide • Structure and content of subject and study design data in electronic files ADaM & ADaMIG • Analysis Data Model, Implementation Guide • Structure of analysis datasets © CDISC 2016 CDISC Standards (2) ODM LAB Controlled Terminology • Operational Data Model • XML model for describing, transmitting & managing CRFbased data • Laboratory • Content standard for defining lab data • Defines code lists/controlled terms for CDISC variables • NCI’s Enterprise Vocabulary Enterprises provides controlled versioned management Devices • CDASH, SDTM & Controlled Terminology done together • Initial focus: Implantable & similar devices BRIDG • Biomedical Research Integrated Domain Group Model • Framework for clearly defining data elements and for linking and harmonizing to other standards © CDISC 2016 CDISC Standards (3) SHARE • Shared Health and Research Electronic Library • Central electronic repository for CDISC standards • In development PRM • Protocol Representation Model • Structured way of describing protocol elements that allows them to be search on, e.g., eligibility criteria SEND • Standard for the Exchange of Non-clinical Data • Pre-clinical data exchange definitions, currently animal toxicology and reproductive toxicology Healthcare Link • Gateway/system for moving data between EHRs and EDC • Based on required CCD output from all EHRs Therapeutic area standards • Alzheimer’s, Polycystic Kidney Disease, TB, selected biomarkers, et al â CDISC 2016 Standards-Related Resources ã CDISC website http://www.CDISC.org Information about CDISC, the standards, education/training, membership, sponsorship, meetings/events, and more • CDISC User Networks www.cdisc.org/cdisc-user-networks • CDISC Discussion Forum www.cdisc.org/forum • EVS Controlled Terminology http://www.cancer.gov/cancertopics/terminologyresources/CDISC • FDA Data Standards Applies mostly to CDER & CBER http://www.fda.gov/ForIndustry/DataStandards/StudyDataStandards/default.htm CDRH standards page http://www.fda.gov/medicaldevices/deviceregulationandguidance/datastandards medicaldevices/default.htm • LinkedIn CDISC Groups www.linkedin.com/grps • PhUSE www.phuse.eu • MAGI: http://www.magiworld.org/standards/ • NIH: https://ncats.nih.gov/expertise/clinical © CDISC 2016 CDISC Education: Classroom Public Licensed Private • Include major standards, e.g., CDASH, SDTM, ADaM • Regularly scheduled public events in major cities globally • Private training can be requested at any time CDISC Education: Online On Demand Courses • • • • Most major standards Therapeutic area standards 30-minute modules grouped into courses Videos, voice over slides, exercises Mini-Training Webinars • • • • 60-90 minute members-only webinars Recorded and available on members site Deeper dive into focused topics Video, voice over slides, recorded Q&A Public Webinars Free modules • 60-90 minute webinars later available online • Focus on recently released draft and final standards • Video, voice over slides, recorded Q&A • Selected free modules available at http://cdisc.trainingcampus.net CDISC Contact Information and Helpful Links • For CDISC membership inquiries, please contact membership@cdisc.org • For CDISC education inquiries, please contact training@cdisc.org • For general CDISC inquiries, please contact info@cdisc.org • Click here for more info on CDISC Education • Click here for more info on CDISC Membership • For help on handling FDA data issues: edata@fda.hhs.gov • For help with FDA submission issues: esub@fda.hhs.gov © CDISC 2016 For More on the World of Standards… Please visit http://kestrelconsulting.trainingcampus.net, create an account, click Product Catalog, C-11 Free Courses from Kestrel, Kestrel-014a-Overview of Standards 2013 Webinar includes definitions of the acronyms in the slides, and explanations of the organizations’ functions The World of Standards webinar was created by Kit Howard when she was a consultant at Kestrel It is not endorsed by CDISC Kit is not currently accepting consulting engagements © CDISC 2016 ... more • CDISC User Networks www .cdisc. org /cdisc- user-networks • CDISC Discussion Forum www .cdisc. org/forum • EVS Controlled Terminology http://www.cancer.gov/cancertopics/terminologyresources /CDISC. .. modules available at http:/ /cdisc. trainingcampus.net CDISC Contact Information and Helpful Links • For CDISC membership inquiries, please contact membership @cdisc. org • For CDISC education inquiries,... please contact training @cdisc. org • For general CDISC inquiries, please contact info @cdisc. org • Click here for more info on CDISC Education • Click here for more info on CDISC Membership • For