CDISC Day Copenhagen Day Copenhagen... · CDISC Europe Interchange Basel, Switzerland - 4-8 May...

© CDISC 2015 1

CDISC Day – Copenhagen

Europe CDISC Coordinating Committee (E3C),

CDISC Operations & CEF

18 February 2015

© CDISC 2015

Agenda

• 0900 Welcome and Introductions

• 0915 E3C Update

• 0930 CDISC News & Foundational Standards

• 1000 CDISC Implementation Experiences

• 1100 Looking Toward the Future

• 1130 CDISC Education & Europe Interchange 2015

• 1200 Lunch

• 1300 Roundtable / Q&A

• 0415 Wrap up

2

© CDISC 2015 3

Thanks to SAS for hosting!

Welcome to Attendees

© CDISC 2015 4

• Peter Van Reusel

Business & Decision Life Sciences

• Bron Kisler

CDISC

• Paul Houston

CDISC

• Mark Lambrecht

SAS

• Jörg Dillert

Oracle

Introduction and

Meeting Approach

© CDISC 2015 5

Review Agenda

© CDISC 2015 6

Review Agenda

© CDISC 2015 7

E3C Update: The 14th Year

Peter Van Reusel

Chair, CDISC E3C

© CDISC 2015 9

Current E3C Members

• Chair Peter van Reusel, BDLS, Belgium

• Vice-Chair Jörg Dillert, Oracle, Germany

• Full Members Andrea Rauch, Boehringer-Ingelheim, Germany

Mark Lambrecht, SAS, Belgium

Daniel Graham, Astra Zeneca, UK

• CDISC E3C Liaison Bron Kisler, CDISC, US

Paul Houston, CDISC, UK

• CDISC Board Member Stephen Pyke, GSK, UK

Pierre-Yves Lastic, Sanofi, France

• CDISC funded Support Diana Harakeh, CDISC

Dominik Ruisinger, EuroInterchange Organization

© CDISC 2015 10

E3C Charter

• Purpose Yearly action plan, aligned with CDISC Strategic Goals

Organize & Promote CDISC Interchanges for Europe

Liaise with regulatory authorities on behalf of CDISC

Assess regional CDISC training needs

Assist in the creation & coordination of European User Networks

Communicate activities

• Composed of volunteers Sponsors

CRO

Vendors

Academia

• Represent Europe

© CDISC 2015

E3C Call For Nominations

Candidates Should: • represent CDISC member organizations

• support the CDISC mission

• understand the value of the CDISC Data Standards

• actively support the development, adoption and

implementation of the CDISC Data Standards

• volunteer, self-funding

• make their time available for their E3C duties

• attend 2 face-to-face meetings per year

• attend monthly teleconference calls and undertaking

individual tasks

• be European

11

Deadline 16 MARCH 2015!

12

Annual

Meetings Workshops

Frankfurt 2002

Dublin 2003

Interchanges Brussels 2004

Paris 2005

Berlin 2006

Montreux 2007

Copenhagen 2008

Budapest 2009

London 2010

Brussels 2011

Stockholm 2012

Frankfurt 2013

Paris 2014

Basel 2015

Paris

London

Brussels

Dublin

Budapest

Stockholm

Copenhagen

Frankfurt

Berlin

Basel

Montreux

13

CDISC Europe Interchange Basel, Switzerland - 4-8 May 2015

Call for Abstracts

Open until 5 Jan 2015

Become a Sponsor Today

Place Your Logo Here!

Global Diamond

Sponsor:

CDISC Day

18 February 2015

Copenhagen

SAS Denmark

Købmagergade 7-9

DK-1150 København K

Denmark

Agenda – Advanced Level

14

© CDISC 2015 15 15

Liase with European

Regulatory Agencies

• E.g. EHR4CR

• E.g. Represent CDISC on Clinical Trial

Data & Transparancy

© CDISC 2015 16

Strength through collaboration.

Questions? Peter Van Reusel ([email protected])

mailto:[email protected]

© CDISC 2015 17

CDISC News & Foundational

Standards

Peter Van Reusel

Chair, CDISC E3C

Bron Kisler

CDISC Operations

© CDISC 2015 18

Foundational Products Released in 2014:

• Dataset-XML v1 Final

• SDTMIG 3.3 Batch 1 (7 draft domains)

• SDTMIG 3.3 Batch 2 (Milestones, 2 Domains)

• Pharmacogenomics SDTMIG v1 Draft

• SEND v3.1 Draft

• ADaM Occurrence Data Structure v1 Draft

• ADaM IG v1.1 Draft

• ADaM Results Metadata Spec for Define-XML

• Periodic Terminology and COA Packages

• Updated COP and Process Docs

Upcoming New Drafts for Comment:

• ADaM Data Structure for Integration (ADSL)

• CDISC in RDF Reference Guide (PhUSE)

• CDASH v2 and Model

• Define-XML IG & Validation Rules

Progress Update – Foundational Stds

© CDISC 2015 20

CDISC Technical Plan

© CDISC 2015

Foundational Standards

Semantics

Therapeutic Areas (CFAST)

CDISC SHARE R1 R2 R3

BRIDG

Track 1 Projects

Track 2 Projects

Track 3 Projects

XML Technologies

Health Care Interoperability

Data Exchange Layer XML, RDF, …

Semantic Layer BRIDG/Terminologies/SHARE

Functional Layer SDTM, SEND, ADaM, CDASH …

Implementation Layer Therapeutic Area Guides,

Questionnaire Guides

Healthcare Interoperability

Kits

SDS/SDTM Products

CDASH

SEND

Others

ADAM

PROTOCOL

Controlled Terminology

21

The Roadmap depicts evolution from siloed standards to an integrated stack based on BRIDG and SHARE

CDISC Technical Roadmap

© CDISC 2015

BINDING DOCUMENTS

FDASIA Update:

Regulatory Documents

22

© CDISC 2015

Technical Conformance

Guidance

eStudy Data Guidance

Implementation Guidance

⌘

⌘

⌘: Binding Document

23

Relationship between Documents Food and Drug Administration Safety & Innovation Act (FDASIA)

© CDISC 2015

• Final published December 2014

• Framework for submissions on electronic format

• Applicable to INDs, NDAs, ANDAs, BLAs

• Exemptions can be obtained

Implementation of Regulatory

eSubmissions – How?

24

© CDISC 2015

Final published December 2014

NDAs, ANDAs and certain BLAs

Must follow details in the Data Standards Catalogue for all studies with earliest informed consent date 24 months after Federal Register notice of final guidance availability

Certain INDs

Must use specified formats in studies with earliest informed consent date 36 months after Federal Register notice of availability

Requirement of Study Data

Standards – When?

25

© CDISC 2015

FDA Data Standards Catalogue v4.0 http://www.fda.gov/ForIndustry/DataStandards/StudyDataStandards/default.htm


Standards – What?

26

© CDISC 2015

• Version 2.0 published December 2014

• Non-binding details on submitting standardized study data

• The document is a mix between the CDER common data issues and new information (e.g. TA standards)

• New release always on 15 March 20xx


Standards – How?

27

© CDISC 2015

FDA Submissions using CDISC

28

© CDISC 2015

Controlled Terminology

29

© CDISC 2015 30

http://www.pmda.go.jp/english/service/pdf/taskforce/140620-tsuchi_e.pdf




© CDISC 2015

CDISC Terminology Development

32

© CDISC 2015

CDISC Terminology Development

33

0

5000

10000

15000

20000

25000

2006 2007 2008 2009 2010 2011 2012 2013 2014

650 1003 2301 2681

4896

10909

15524

18993

22365

© CDISC 2015

2014 Terminology Highlights

34

• New TEST/TESTCD codelists to support SDTM

Domains MO, NV, PF, DD, VR, OE

FATEST/TESTCD codelists for Multiple Sclerosis, Hepatic and

Cardiovascular standards.

• SEND IG 3.1 terminology updates terminology will be published in the SEND CT file in Q1 2015

(end of March).

• Terminology Support of TA projects Alzheimers v2, Asthma, Cardiovascular, Multiple Sclerosis,

Traumatic Brain Injury, QT studies, Hepatitis C, Influenza,

Oncology, COPD, Dyslipidemia, and Schizophrenia.

© CDISC 2015

CDISC ‘Change’ Requests

35

0

1000

2000

3000

4000

5000

6000

2009 2010 2011 2012 2013 2014

III

II

I

© CDISC 2015

Therapeutic Areas Affect on

Change Requests

36

COA – QS/FT/CC SDTM/SEND/ADaM

308

65

2013

Non-TA Specific

TA Specific

1949

872

2014

Non-TA Specific

TA Specific

1614

458

2013

Non-TA Specific

TA Specific

3625

213

2014

Non-TA Specific

TA Specific

© CDISC 2015

• Clinical Outcome Assessments (COA) Terminology

CDISC Controlled terminology support for

Questionnaires (QS), Functional Tests (FT), and Clinical

Classifications (CC) domains

• Name of QS/FT/CC instrument in --CAT variable

• Verbatim Question Text for QS/FT/CC instrument in --TEST and

–TESTCD variable

No published controlled terminology for the question

responses

QS/FT/CC Supplements are created for each published

instrument

• Describes the CDISC implementation of a COA with annotations

• Location - cdisc.org/standards/foundational/questionnaires and

functional tests

37

Clinical Outcome Assessments

© CDISC 2015 38

Novo Nordisk: CDISC

Implementation Experiences

Marianne Caramés

Mikkel Traun

Sofie Inari Castella

© CDISC 2015 39

Looking Toward the Future…

Bron Kisler

CDISC Operations

Paul Houston

CDISC Europe Foundation (CEF)

© CDISC 2015

IMI and CDISC

• CDISC and IMI have a Memorandum of

Understanding in place

• IMI is a CDISC Platinum member

• IMI encourages the use of CDISC standards

across IMI projects…

• as well as participation in standards

development where standards have not been

developed

• CDISC Europe Foundation is a Research Entity

and a partner within three of the current IMI

consortia

40

© CDISC 2015

EHR4CR Electronic Health Records for Clinical Research http://www.ehr4cr.eu is in its fourth

year and CDISC is contributing to the semantic interoperability and pilot work

packages to ensure reuse of data from Electronic Health Record systems for

Clinical Research.

BioVacSafe Biomarkers for Enhanced Vaccine ImmunoSafety http://www.biovacsafe.eu is

entering its third year. CDISC is working closely with Charité University (Germany),

University of Surrey (UK), and global vaccine manufacturers on a data standards

package and a Vaccine standard.

eTRIKS European Translational Information & Knowledge Management Services

http://www.etriks.org is now in its second year. CDISC is leading the data standards

work package with Roche. Building upon the open source tranSMART system,

eTRIKS will provide a sustainable Knowledge Management Platform and Service to

support Private/Public Translational Research (TR) across IMI, bringing curated

data together from key IMI project consortia.

41

IMI Consortia and CEF

http://www.ehr4cr.eu

http://www.biovacsafe.eu

http://www.etriks.org

© CDISC 2015

EHR Face Sheet

42

Retrieve

Form

© CDISC 2015 43

• IMI2 – Strategic Governance Groups to cascade down WP3

recommendations – (CDISC will be at the core for clinical

data). BRIDG will be an underlying model and PGX to

connect some clinical and genomic data.

• Standards starter Pack v1. end of March 2015. New intro

section ‘standards make life easier’.

• Meta Data Registry – mappings of meta data for all

standards. External collaboration with SHARE and NCBO

MDR work – Cedar project.

• Looking for case study and project with GA4GH to prove

standards with API and MOU for consistency with BRIDG and

template team.

• Transmart MasterTree structure now SDTM/CDASH

eTRIKS Highlights

© CDISC 2015

Varaiable Name Variable Label Core Type Len Length Value Comments Common/Rare CodeCodelist

Code

Codelist

Extensible

(Yes/No)

Codelist

Name

CDISC

Submission

Value

CDISC

Synonym(s)

CDISC

Definition

NCI

Preferred

Term

STUDYID Study Identifier Req Char 20 20 Entry field for sites C

DOMAIN Domain Abbreviation Req Char 2 2 Add a new field C

USUBJID Unique Subject Identifier Req Char 20 30 STUDYID+SUBJID+SITEID Derived field R

SUBJID Subject Identifier for the Study Req Char 20 5 Entry field for sites C

RFSTDTC Subject Reference Start Date/Time Exp Char 19 19 Entry field for sites R

RFENDTC Subject Reference End Date/Time Exp Char 19 19 Recommended date format is DD-MMM-YYYY R

SITEID Study Site Identifier Req Char 5 5 Entry field for sites C

INVID Investigator Identifier Perm Char 20 10 Entry field for sites C

INVNAM Investigator Name Perm Char 45 50 Entry field for sites C

BRTHDTC Date/Time of Birth Perm Char 19 19 Recommended date format is DD-MMM-YYYY C

AGE Age Exp Num 2 3 Derived/Entry C

AGEU Age Units Exp Char 5 5 Add a new field R

SEX Sex Req Char 1 10 Depending on the CRF/eCRF. Recommendation is formats C C66731 No Sex SEX Sex The

assemblag

CDISC

SDTM Sex C16576 C66731 Sex F Female A person

who

Female

C20197 C66731 Sex M Male A person

who

Male

C17998 C66731 Sex U U; Unknown Not known,

not

Unknown

C45908 C66731 Sex UN Undifferentiat

ed

A person

(one of

Intersex

RACE Race Exp Char 50 50 Depending on the CRF/eCRF. Recommendation is formats C C74457 No Race RACE Race Terminolog

y codelist

CDISC

SDTM Race C16352 C74457 Race BLACK OR

AFRICAN

A person

having

African

AmericanC41259 C74457 Race AMERICAN

INDIAN OR

A person

having

American

Indian or C41260 C74457 Race ASIAN A person

having

Asian

C41219 C74457 Race NATIVE

HAWAIIAN

Denotes a

person

Native

Hawaiian or C41261 C74457 Race WHITE Denotes a

person

White

ETHNIC Ethnicity Perm Char 50 50 Depending on the CRF/eCRF. Recommendation is formats C

ARMCD Planned Arm Code Req Char 20 20 The same data is avilable in trail arms R

ARM Description of Planned Arm Req Char 20 20 The same data is avilable in trail arms R

COUNTRY Country Req Char 30 30 R C66786 No Country COUNTRY Country A collective

generic

CDISC

SDTM C17884 C66786 Country ABW ARUBA Island in

the

Aruba

eTRIKS CDISC CDISC SDTMIG v3.1.3 SDTM Control terminilogy (CT)

3. Demographic STANDARD dataset

Transmart Master Tree eTRIKS - WP3&WP4

1. References sources: CDISC- SDTM& CDASH guidelines & SDTM control

terminology

2. Standards Demographic Master Tree

Specification

4. TranSMART Dataset Demographic Master Tree

specification

5. TranSMART Dataset Demographic Master Tree

© CDISC 2015

Other European Activity

• Modus operandi established between EMA and CDISC Leadership

• Exploring future collaborative opportunities such as Clinical Trial Registration & Results harmonisation, CTReg phase 1 EMA, WHO and US ClinicalTrials.gov

CTReg phase 2 – CTReg & Results (PRM to AdAM)

TA areas, CFAST Steering Committee Membership.

Eventual Patient Level Data requirements and SDTM

Patient de-identification

• COMET initiative Core Competency Sets, Horizon 2020 project.

• Staff hires – John Owen (Therapeutic Area Standards), Dorina Bratfalean (Data Management expert), Paul Houston, secretariat function.

© CDISC 2015

CDISC – End to End (quality, speed, provenance)

Protocol

SDTM

Analysis ADaM

Data Capture

ODM

Database

ODM

CDASH

eCRFs

© CDISC 2015

Collaborations & Governance

CFAST TAPSC Therapeutic Area Program

Steering Committee

CFAST SAC Scientific Advisory Committee

• Prioritizes/Approves Proposals

• Approves Projects & Charters

• Resources & Oversees Projects

• Provides Scientific Advice to TAPSC

• Identifies Risks and Opportunities

• Identifies/Engages Relevant Partners

47

© CDISC 2015

CFAST Priorities for TA Standards

48

© CDISC 2015

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

TCB

John Owen Nov 13 Feb Apr Jul Nov Jan Q115

Schizophrenia v1 CDISC/DCRI

Amy Palmer Nov 13 May Jul Aug Dec Mar Q215

Breast Cancer v1 TCB

John Owen Nov 13 Aug Dec Jan Mar May Q315

Dyslipidemia v1 TCB

John Glover Dec 13 May Sept Dec Feb Apr Q215

COPD v1 TCB

John Glover Nov 13 Aug Dec Feb Apr Q315

ADaM Supplement to

Diabetes v1

TCB

Rachael

Zirkle

NA NA NA Jan Mar Q215

Diabetic Kidney Disease

v1

TCB

Rachael

Zirkle

May 14 Feb Mar Q116

Tuberculosis v2 C-Path

Laura Butte Dec 14 Mar Apr Q116

Rheumatoid Arthritis v1

TCB

Trisha

Simpson

Jul 13 Feb Q116

CV Imaging v1 CDISC/DCRI

Amy Palmer Dec 13

Stage completed Stage ongoing | All months reflect when stage is, or is projected to be, completed.

49

© CDISC 2015

Other CDISC TA and Specialty

Area Projects

50

• Ebola Virus – Oxford University Centre for

Tropical Medicine and Global Health

• Malaria – Worldwide Antimalarial

Resistance Network (WWARN)

• Vaccines – IMI Biovacsafe

• Nutritional Research

• Traditional Chinese Medicine

© CDISC 2015

eSHARE Downloads Page

51

© CDISC 2015

SHARE R2 – 2014 Milestones

# Milestone Status

1 eSHARE content download site Complete

2a Load SDTM 3.1.3 Complete

2b Load SDTM 3.2 Complete

3 SEND content Complete

4 RDF/OWL export format Pending Public Review

5 Research concepts prototype Complete

6 ADaM content Complete

7 Value Level Metadata content Complete

8 Research concepts meta-model and initial

content

Complete

52

© CDISC 2015

SHARE Road Map:

Incremental Implementation

53

R1

Q1 2014

R2

Q4 2014

R3

Q4 2015

R4

Q4 2016

Major Versions: Releases 1 - 4

© CDISC 2015

R3: End-to-End Standards Model

• R1 Theme: Machine-Readable Standards

• R2 Theme: SHARE Concept Model

• R3 Theme: End-to-End Standards Model

• R4 Theme: Multiple Concept Systems

54

R3

Q4 2015

© CDISC 2015

SHARE R3 – 2015 Epics

# SHARE Epic Title Status

1 CDISC End-to-End Model Published Pilot Initiated

2 Load Protocol Standard Planning

3 SHARE Curator Services Pilot Initiated

4 Apply Research Concepts Pilot Initiated

5 SHARE API Planning

6 Validation Rules

7 Implementation Guides

8 Expanded eSHARE Content Ongoing

9 Comprehensive RDF Public Review

10 Communicate the value

11 Interactive, collaborative governance

55

© CDISC 2015

Research Concepts – Key Points

• A Research Concept is a unit of knowledge created by a unique combination of characteristics. (ISO 11179)

• In general, for CDISC: Research Concepts are high-level building blocks of clinical research information that encapsulate lower level implementation details like variables and terminologies.

• For SHARE: A Research Concept is a unique, meaningful combination of SHARE Concepts and Rules that define the independent units of knowledge found within each CDISC class.

• Research Concepts: Critical selling point that heavily influenced TCB to fund SHARE.

• SHARE provides the repository for RCs and Value Level Metadata But, no current RC content means big effort to develop

Three RC content pilots ongoing – TAs, RC content, End-2-End Metadata

56

© CDISC 2015 57

LDL (C105588)

PLASMA (C13356)

SERUM (C13325)

BETA QUANTIFICATION (new)

COLORIMETRY (C111096)

Mg/dL (C67015)

Mmol/L (C111096)

• Research Concept: Low Density Lipoprotein

• Value Level Metadata for Lab Test = LDL

• Method, Specimen and Unit are subsets of the much larger codelists

VLM based on Test Name = LDL

© CDISC 2015

SHARE API Program

• Programmatic access to SHARE content

• Targeted at vendors and MDR implementations

Allows vendors to offer seamless SHARE integration

Allows MDR users to pull automated updates

• Aim to eliminate the need to manually load standards

content into MDRs and other software

• Will require additions to the SHARE technical and

support infrastructure

60

© CDISC 2011

SHARE as a Knowledge Resource for Research

61

SHARE

Repository iSHARE

Sponsor

MDR

eSHARE

EDC

Products

Open

CDISC,

Tools

SHARE Metadata Services Bus

External

Repositories

External

Terminologies

& Models

SHARE API

AW

S E

C2 C

lou

d

Batch Load Export

Web

Cli

en

ts

© CDISC 2015

Content = Most Significant SHARE Challenge

• Many of the current initiatives highlight gaps in the

standards metadata End-to-end standards metadata

Research Concepts metadata

Value level metadata

Controlled terminology subsets

Complete TAUG metadata

Protocol standard metadata

Validation rule metadata

Transformation rule metadata

PhUSE standards-like work

Healthcare interoperability linkages (e.g. LOINC codes)

• These gaps limit the ability to automate clinical

research data processes

62

© CDISC 2015

Classroom Courses

Public Courses – www.cdisc.org/public-courses

• Scheduled at least once a month in different regions

• Cost effective for training a few employees (~1-4)

Private, In-house – www.cdisc.org/private-courses

• Can be scheduled virtually anywhere

• Most cost effective for 5 or more employees

New courses (2014-2015)

• 2-day SEND Implementation

• 2-day SDTM for Medical Device

• ½ day Define-XML

• ½ day Dataset-XML

64

© CDISC 2015

Online Courses

Availability

• On demand 24/7, Self paced

• Certificate issued based on assessment test

Cost

• Most cost-effective means of obtaining authorized courses

• Region-based pricing, and member discounts

• Some introductory modules are free

Courses available (2015-02-01)

• SDTM v3.1.3

• CDASH v1.1

• BRIDG v3.2

• Introduction to ADaM

• Overview of Therapeutic Area User Guides

• Several more are in development (PK, CT, more ADaM, several TAs)

65

© CDISC 2015

Other Resources

Publicly Available Classroom Course Descriptions

• http://www.cdisc.org/course-descriptions

• Available for public or in-house course delivery

Publicly Available Online Course Descriptions

• CDISC Training Campus Product Catalog

• Navigate to CDISC.TrainingCampus.net and click on “Product Catalog”

All Webinars (free resource)

• All are available to member companies (live and on-demand archive)

• Some are available only to members (mini-training series)

CDISC Education Website

• www.cdisc.org/education

• Archived webinars (members log in to access)

66

For more information:

Shannon Labout

[email protected]

http://www.cdisc.org/course-descriptions





mailto:[email protected]

© CDISC 2015

Special Opportunity in May

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

• http://www.cdisc.org/cdisc-europe-interchange-2015

67

© CDISC 2015

One week fully packed

• Mo: Training incl. FDA reviewer training

• Tu: Main Conference, day 1

• We: Main Conference, day 2

• Th: Training

• Fr: Training

70

© CDISC 2015

Program & Abstracts

• FDA, EMA, PMDA, IMI, CFAST, TransCelerate ...

• over 80 abstracts submitted

• certain sessions like TED talks

71

© CDISC 2015

Sessions:

• Plenary sessions

• De-Identification

• Foundational Standards

• SEND

• Strategic, Partner, Future

• User Experience

• TA standards

• Metadata Repository from the Pharma perspective

• CFAST

72

© CDISC 2015

Keynote

Ophthalmic technology development update: the

intersection between man and machine Joe Rappon, OD, MS, FAAO, Global Program Head, Alcon Research, Ltd.

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CDISC Day Copenhagen Day Copenhagen... · CDISC Europe Interchange Basel, Switzerland - 4-8 May...

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