Einführung in die CDISC Standards CDISC Standards around the World. Bron Kisler (CDISC) & Andrea Rauch DVMD Tagung

Transcription

1 Einführung in die CDISC Standards CDISC Standards around the World Bron Kisler (CDISC) & Andrea Rauch DVMD Tagung März

2 Outline Overview of CDISC Therapeutic Area Standards SHARE Metadata Repository Wrap Up / Q&A 2

3 What is CDISC? Clinical Data Interchange Standards Consortium Global Standards Development Organization (SDO) Founded in 1997 (all volunteers) Incorporated in 2000 as a non-profit organization Over 350 member organizations 90 countries; Coordinating Committees in Europe, Japan, China, Asia-Pacific; 20 user networks International Conferences (Europe, Japan, US); Robust education program Mission: To develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare 3

4 CDISC has established worldwide industry standards to support the electronic acquisition, exchange, submission and archiving of clinical research data and metadata to improve data quality and streamline medical and biopharmaceutical product development and research processes Consensus-based development Standards are freely available at IP Policy ensures open standards 4

5 CDISC Standards SDTM 5

6 CDISC Standards (others) 6

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9 Update December 2014 binding documents 9

10 Requirement of Study Data Standards What? FDA Data Standards Catalogue v

11 FDA Submissions using CDISC 11

12 Therapeutic Area Standards 12

13 Coalition For Accelerating Standards & Therapies Formed by CDISC and the Critical Path Institute (C-Path) A joint initiative to accelerate clinical research and medical product development by creating and maintaining data standards, tools and methods for conducting research in therapeutic areas that are important to public health With the enactment of FDASIA/PDUFA V, FDA recognized the opportunity to work with CFAST, along with the pharmaceutical industry, to develop therapeutic area data standards. CFAST Steering & Advisory Members: 13

14 CFAST Program Plan Feb 2015 Therapeutic Area Coordinating Organization/ Project Manager Proposal Approval Date Stage 0 Scoping & Planning Stage 1 Concept Modeling Stage 2 Standards Development Stage 3a Internal Review *Stage 3b Public Review *Stage 3c **Projected Publication Traumatic Brain Injury v1 CDISC Rhonda Facile Oct 13 Dec Jan Feb Mar Q315 Chronic Hepatitis C Virus v1 Schizophrenia v1 Breast Cancer v1 Dyslipidemia v1 COPD v1 ADaM Supplement to Diabetes v1 Diabetic Kidney Disease v1 Tuberculosis v2 Rheumatoid Arthritis v1 CV Imaging v1 TCB John Owen CDISC/DCRI Amy Palmer TCB John Owen TCB John Glover TCB John Glover TCB Rachael Zirkle TCB Rachael Zirkle C-Path Laura Butte TCB Trisha Simpson CDISC/DCRI Amy Palmer Nov 13 Feb Apr Jul Nov Jan Q115 Nov 13 May Jul Aug Dec Mar Q215 Nov 13 Aug Dec Jan Mar May Q315 Dec 13 May Sept Dec Feb Apr Q215 Nov 13 Aug Dec Feb Apr Q315 NA NA NA Jan Mar Q215 May 14 Feb Mar Q116 Dec 14 Mar Apr Q116 Jul 13 Feb Q116 Dec 13 Stage completed Stage ongoing All months reflect when stage is, or is projected to be, completed. 14

15 SHARE Metadata Repository 15

16 Global electronic repository for developing, integrating and accessing CDISC standards metadata in electronic format. SHARE should dramatically improve the quality, reusability and integration across CDISC standards and controlled terminologies, and improve interoperability with healthcare. SHARE is the foundation for standards-based automation, which is critical to maximizing the Return on Investment of implementing standards CDISC

17 User Perspectives of SHARE SHARE ishare (SHARE Interactive) eshare (SHARE Exports) Standards Development & Governance Accessing Published Standards in a Machine-Readable Format CDISC

18 eshare Downloads Page CDISC

19 CDISC Europe Interchange Basel, Switzerland May 2015 Call for Abstracts Open until 5 Jan 2015 Become a Sponsor Today Place Your Logo Here! Global Diamond Sponsor: 19

20 Special Opportunity 4 May 2015 FDA Review workshop Experience the review process from the Reviewer s perspective 1-day session led by FDA representatives Interactive, hands on Registration open now Access online or offline registration

21 Thank You! Questions? Strength through collaboration 21

22 Sponsor s Structure for Vital Signs: One Record per Subject per Visit SUBJID VSDTM SYSBP mmhg DIABP mmhg SDTM Structure for Vital Signs: PULSE bpm TEMP C USUBJID VSTESTCD VSORRES VSORRESU VSTDC ABC-0001 SYSBP 120 mmhg ABC-0001 DIABP 80 mmhg ABC-0001 PULSE 65 bpm ABC-0001 TEMP 37 C Former column names become values in TESTCD Units are taken from former labels 22

23 SDTM Domains Collection of logically related observations sharing a common topic consisting of Data in one domain can come from multiple CRF pages; Data on one CRF page can go to multiple domains Typically represented by a single dataset Dataset name = two letter Domain code Structured as flat files three general (row = observation; column = variable) Additional sponsordefined custom domains as per specific study requirements CDISC SDTM Standard Domain Models (CDISC SDTM Implementation Guide version 3.2) Special Purpose Domains (Section 5) Demographics (DM) Comments (CO) Subject Elements (SE) Subject Visits (SV) General Observation Classes (Section 6) Domain datasets, Interventions (Section 6.1) Findings (Section 6.3) Intentionally administered treatments/ procedures Demographics (DM), Trial Design Model Concomitant Meds (CM) Comments (CO), Exposure (EX) (TDM) datasets, such Substance use (SU) Subject Elements as Trial Arms (TA) and (SE), and Subject Trial Elements (TE), Visits (SV), all of Events which (Section which 6.2) represent Observations independent of planned study include subject-level information about the evaluations data that do not study design but do not Adverse Events (AE) conform to one of Medical the History (MH) contain subject data. observation classes. Clinical Events (CE) Disposition (DS) Protocol Deviations (DV) Trial Design Domains (Section 7) Planned evaluations to address specific questions ECG (EG) Laboratory Test Results (LB) Questionnaires (QS) Relationship datasets, Vital Signs (VS) Microbiology which include Specimens the (MB) PK Concentrations (PC) RELREC and SUPP-- In-/Exclusion not met (IE) Physical datasets Exam (PE) Subject Characteristics (SC) Drug Accountability (DA) PK Parameters (PP) Findings About (FA) *(Section 6.4) Trial Arms (TA) Trial Visits (TV) Trial Summary (TS) Trial Elements (TE) Trial In/Excl Criteria (TI) Relationship Datasets (Section 8) Supplemental Qualifiers (SUPPQUAL or multiple or multiple SUPP-- datasets) SUPP-- datasets) Relate Records (RELREC) 23

24 SDTM vs. ADaM: SDTM (Study Data Tabulation Model) Mainly source raw data data with only a few derived variables No redundancy Primarily character variables Structure well defined (but inflexible) ADaM (Analysis Data Model) Includes source and sponsorderived variables and observations Redundancy (needed for analysis and traceability) Character and numeric variables (needed for analysis) Generic structures defined, but more flexible Domain per topic Dates are ISO8601 character strings Includes variables from multiple domains driven by analysis purpose Dates are numeric to allow calculations 24