1. CDISC UK Network Jun-16 – Welwyn
Operational Implementation of
Metadata Defined Standards
…with reference to Define.XML
Andy Richardson
Peter House, Oxford Street, Manchester, M1 5AN United Kingdom
CDISC UK Network Jun-16 – Welwyn
[1]

2. CDISC UK Network Jun-16 – Welwyn
Standards Operational Implementation
The primary objective of the CDISC standards is to describe clinical/non-clinical data products and associated artefacts
Industry objectives are to exploit the standards
to comply with regulatory requirements
to support efficient end-2-end clinical operations
for other data interchange
Standards need to be carefully integrated into clinical operations in order to maximize the benefits of adoption
The operational role for each adopted standard needs to be fully understood
CDISC UK Network Jun-16 – Welwyn
[2]

3. Implemented Standards (Study Data)
Standards Operational Implementation
Standards Operational Model
Standards
States
CDISC Standards
Operational Model
Planning
Protocol
Data Analysis
ADaM
Data Tabulation
SDTM
CDASH
LAB
Data Collection
Published
Standards
Modified
User
SDTM v3.1.2
ADaM
SDTM v3.1.3
CDASH
V1.1
mSDTM
mADaM
CRF Standards
uSDTM
Adopted
Standards
(Study Specs)
CRF Standards
SDTM v3.1.2
ADaM
mSDTM
Implemented Standards (Study Data)
[3]

4. Implemented Standards (Study Data)
Standards Operational Implementation
Standards Operational Model
CDISC Standards
Operational Model
Planning
Protocol
Data Analysis
ADaM
Data Tabulation
SDTM
CDASH
LAB
Data Collection
Published
Standards
Modified
User
SDTM v3.1.2
ADaM
SDTM v3.1.3
CDASH
V1.1
mSDTM
mADaM
CRF Standards
uSDTM
Adopted
Standards
(Study Specs)
CRF Standards
SDTM v3.1.2
ADaM
mSDTM
Implemented Standards (Study Data)
[4]

5. Implemented Standards (Study Data) Controlled Terminology
Standards Operational Implementation
Standards Operational Model - Extended
CDISC Standards
Operational Model
Planning
Protocol
Published
Standards
Modified
User
Adopted
(Study Specs)
Implemented Standards (Study Data)
CDASH
LAB
Data Collection
V1.1
CRF Standards
Data Tabulation
SDTM
SDTM v3.1.2
SDTM v3.1.3
mSDTM
NCI
Sponsor
Controlled Terminology
Codelists
Data Analysis
ADaM
uSDTM
mADaM
[5]

6. CDISC UK Network Jun-16 – Welwyn
Standards Operational Implementation
Define-XML Purpose…
… [a] model… used to describe CDISC SDTM, SEND and ADaM datasets for the purpose of submissions to the FDA, .. [and] proprietary [non-CDISC] standards
TOCs…
CDISC UK Network Jun-16 – Welwyn
[6]

7. Implemented Standards (Study Data) Controlled Terminology
Standards Operational Implementation
Standards Operational Model - Extended
CDISC Standards
Operational Model
Planning
Protocol
Published
Standards
Modified
User
Adopted
(Study Specs)
Implemented Standards (Study Data)
CDASH
LAB
Data Collection
V1.1
CRF Standards
Data Tabulation
SDTM
SDTM v3.1.2
SDTM v3.1.3
mSDTM
NCI
Sponsor
Controlled Terminology
Codelists
Data Analysis
ADaM
uSDTM
mADaM
[7]

8. Implemented Standards (Study Data) Controlled Terminology
Standards Operational Implementation
Standards Operational Model – Extended – Define.XML
CDISC Standards
Operational Model
Planning
Protocol
Published
Standards
Modified
User
Adopted
(Study Specs)
Implemented Standards (Study Data)
CDASH
LAB
Data Collection
V1.1
CRF Standards
Data Tabulation
SDTM
SDTM v3.1.2
mSDTM
NCI
Sponsor
Controlled Terminology
Codelists
Define
.XML
Data Analysis
ADaM
uSDTM
mADaM
V2.0
[8]

9. Operational Implementation
Standards Operational Implementation
Operational Implementation
Requires careful consideration of the standards role within the operation...
Define.XML – for dataset DESCRIPTION or dataset DEFINITION (REVIEW/APPROVAL)?
Needs to understand how and where it interacts with other operational deliverables…
Define.XML – aCRF, Controlled Terminology, Trial Datasets, Complex and Computation Algorithms, Reviewers Guides etc…
Needs to be part of the governance, data traceability, production, versioning processes and procedures…
Define.XML – Primary starting point for data traceability? QC methods?
[9]

10. Andy Richardson Peter House Oxford St. Manchester M1 5AN, UK
Standards Operational Implementation
Andy Richardson
Peter House
Oxford St.
Manchester
M1 5AN, UK
[10]