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]

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]

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]

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]

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]

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]

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]

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]

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]

Andy Richardson Peter House Oxford St. Manchester M1 5AN, UK Standards Operational Implementation Andy Richardson Peter House Oxford St. Manchester M1 5AN, UK andy.richardson@d-wise.com www.d-wise.com [10]