SAS offers technology to facilitate working with CDISC standards : the metadata perspective.

Transcription

1 SAS offers technology to facilitate working with CDISC standards : the metadata perspective. Mark Lambrecht, PhD Principal Consultant, Life Sciences SAS

2 Agenda SAS actively supports CDISC standards Tools approach (PROC CDISC, XML) : the foundation Clinical DI : building the house The industrial approach in CDISC mapping : clinical DI Now that the metadata is gathered What will SAS bring next?

3 SAS actively supports CDISC standards

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6 SAS and CDISC SAS supports the effort to replace v5 xport file type with multiple modern, extensible XML file type SAS is actively involved in multiple modeling committees: SDTM, ADaM, Protocol, ODM, etc. SAS has invested, and will continue to invest, in a variety of CDISC-enabling technologies

7 Delivery format : the old

8 Delivery format : the new

9 Tools approach : the foundation

10 XML XML libname engine Manipulating XML ODM native mode XML Mapper : mapping rectangular format to/from hierarchical XML XML conformance : 3 levels

11 SAS XML Libname Engine ODM Syntax Declare input source Declare output source Load data from ODM XML into SAS data set Save data from SAS data set into ODM XML 11

12 PROC CDISC Input CDISC ODM XML files to SAS data set(s) Output SAS data set content to CDISC ODM XML Validates CDISC SDTM content against model

13 PROC CDISC validation for SDTM Verifies all required variables are present Identifies dataset variables not defined in domain Identifies missing, but expected, domain variables Identifies missing, but permitted, domain variables Verifies variables are of expected type and length Identifies missing, but expected, controlled terminology (formats)

14 Proc CDISC Capabilities Input CDISC ODM XML files to SAS data set(s) Output SAS data set content to CDISC ODM XML 14

15 Staying Current with Proc CDISC cdisc_prod_9_sysdep.jsp?packageid= then search on CDISC Screenshot from 15-April

16 Proc CDISC Input Syntax for ODM 16

17 Proc CDISC Output Syntax for ODM 17

18 Proc CDISC for SDTM: Metadata Validation Verifies all required variables are present Identifies dataset variables not defined in domain Identifies missing, but expected, domain variables Identifies missing, but permitted, domain variables Verifies variables are of expected type and length Identifies missing, but expected, controlled terminology (formats) 18

19 Proc CDISC for SDTM: Data Validation Verifies that required variables do not contain missing values Identifies expected variables that contain missing values Verifies conformance of all ISO-8601 specification assigned values Notes correctness of yes/no and yes/no/null responses 19

20 Proc CDISC Syntax for SDTM 20

21 CDISC viewer

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23 Clinical DI : building the house

24 Challenges Globalization of reporting tools Implementation of CDISC EDC/CDMS system integration More restrictive regulator demands Data standardization Validation Integration of study-databases

25 External drivers CDISC models Technology and tools need to support SDTM/ADAM model Version management SDTM version Internal SDTM model enhancements Submission driven transformation Define.xml

26 Internal drivers Cooperation Structure of repositories Parent / Child Exchange of programs Exchange of skills Global collection and managing of metadata Transparency Visualization of data streams is possible Reporting of metadata SAS code is generated and can be viewed Security

27 SAS 9 platform

28 Clinical DI Data Integration Server enables easy integration of heterogenous clinical data into CDISC standards SAS DI uses the Open Metadata Architecture Using DI, individual programmer s study knowledge is documented in the metadata and made available for the whole organization

29 Impact of Metadata in Clinical Data Integration Standardization SAS Metadata Server Aggregation Operational Data Submission Documents Validation Analysis

30 Clinical DI Clinical DI brings the CDISC knowledge stored in peoples individual minds into a centralized IT environment, accessible for exploitation and decreasing the time needed for submission of clinical trial data

31 Clinical DI Standardization Components Folder structure Supports best practices Based on SDTM IG Includes: Controlled Terminology Custom Domains Model Classifications Published Domains Relationship Datasets Trial Design Datasets SDTM domain metadata Published domains, Trial Design Domains, and relationship datasets

32 SAS Data Integration Server Visual Standardization Process Drives relationships and associations End up with standardized data AND specific metadata about how data was created

33 Clinical Data Integration Features Overview SAS Management Console Clinical DI Install/Update Plug-in Study Manager Plug-in DI Studio Register Domains SDTM Domain Designer Suppqual Generator Reports Publish SDTM Library Change Management Audit Report SDTM Model Discrepancy Model Analysis Define.xml (beta)

34 SDTM Implementation Guide Centrally Accessible Contains All Domains General Purpose Special-Purpose Special-Purpose Relationship Trial Design Each Domain Contains Table Structure CDISC Table Level Metadata CDISC Column Level Metadata Allows For Custom Domain Expansion

35 SDTM Implementation Guide Domain Level Metadata Column Level Metadata (all columns)

36 Workflow and Change Management Clinical DI components to support best practices in workflow: Clinical Data Integration component installation and administration Setup a study and capture study metadata Register domain to a study based on the standard model definition Generation of suppqual domains based on model Metadata can be leveraged for reporting to support business process Change management through user project folders

37 Study Manager Registers repositories as studies Stores basic study level metadata Associates a SDTM version with the study Drives consistency in using all Clinical DI plugins

38 CDISC Metadata Reporting is Domain Driven

39 PROC CDISC CRT-DDS (Define.xml) VALUELIST CRF METATABLE PROC CDISC DEFINE.XML METACOLUMN METHOD SUPPDOC

40 SAS Clinical Data Integration Benefits Positions the customer to build reusable data management, analysis and reporting processes for clinical studies Follows the CDISC STDM Implementation Guide v3.1.1 (and will support v3.1.2 when it is finalized). SDTM Model Verification. Allows for flexibility and customizations necessary to implement SDTM+/- Enables control and security using SAS Management Console CDISC Metadata Reporting is Domain Driven Change Management Auditing

41 PROC CDISC or Clinical DI? Topic Primary objective Speed of development Re-usability PROC CDISC Final conversion of rectangular SAS table/xml format Moderate Low to medium (macro s) Clinical DI Complete technology for CDISC standarization and submission Fast High : Copy/Paste, Import/Export, Promotion/Replication, Parameterized processes, web services Where are column mappings stored? Globally accessible? Change management Externally stored For use in local code development None Can be attached to data or in external dictionary Globally accessible infrastructure Medium Impact analysis Implicit in code, but complex to retrieve Explicit in metadata/di

42 PROC CDISC or Clinical DI? Topic PROC CDISC Clinical DI SDTM data validation Only partially Fully customizable and standard reports provided CDISC metadata validation Partial ; more to come. Full automated access to metadata, including processes, infrastructure and external documents (CRF, ) Validation of code Paper-based system Well formed code, integrated documentation, synchronized transformations Versions of CDISC standards / internal Difficult to manage and see what code used what version of CDISC models SAS Metamodel allows us to represent CDISC standards as DeployedSoftware that can be linked to studies\projects for integrated consistency

43 We did it before: implementation of clinical DI Evaluation methodology : CDISC-readiness Ingredients Consultants : SAS Clinical DI and CDISC consultants and experts Trained and recognized partners Technology EDC, CDMS, relational databases, ERP, CTMS Critical success factors Risk analysis Adaptation on CDISC metadata (SDTM+/-) Value-level metadata, codelists, specific descriptions, custom domains, supplemental qualifiers

44 What will SAS bring next?

45 Next version of PROC CDISC ODM 1.2 and 1.3 read/write Define.xml (CRT-DDS) read/write Validation for SDTM and Compliance checks Custom checks Available for and 9.2

46 Next version of clinical DI Server brings you A SAS-supported R&D solution More complex and custom validation SDTM content and structure CRT-DDS (define.xml) creation CDISC Models, Version and Format support for Clinical DI Server Controlled terminology ADaM (2.0) LAB, SEND, Protocol Representation, CDASH

47 SAS Universal Viewer Will replace CDISC viewer and will support all CDISC file formats Hierarchical and tabular formats viewing

48 New ISO8601 formats in base SAS 9.2 New series for writing, reading ISO8601 dates, times and *new* intervals (duration).

49 Committed to bringing you CDISC tools and full solutions Continuous R&D effort Working together with customer because of many CDISC-trained consultants and partners in the field Domain knowledge and industry advisory role

50 Copyright 2008, 2006, SAS Institute Inc. All rights reserved.