CDISC SDTM Implementation Real World Application

Training

CDISC SDTM Implementation Real World Application

Course Introduction
This course will walk you through the practical step by step implementations of CDISC SDTM version 3.2 and ADaM 2.0. It will cover both technical challenges with hands on exercises along with methodologies and processes.

About Instructor
Sy Truong is the cofounder and president of MXI (Meta-Xceed, Inc.) since 1997. MXI provides software solutions within the Pharmaceutical Industry specializing in CDISC data standards, SAS validation, electronic submission, data analysis and reporting. Sy is one of the committee members of the Bay Area SAS User Group (www.basas.com). He is a frequent contributor and presenter at PharmaSUG, WUSS, SAS Global Forum and CDISC Interchange conferences.

For pricing information and a quote for a customized training course, please contact MXI .

Course Information
Some of the topics covered in the course include:

Project Definition, Plan and Management
Data Standard Analysis and Review
Data Transformation Specification and Definition
Performing Data Transformation to Standards
Review and Validation of Transformations and Standards
Introduction to Domain Documentation for DEFINE.XML

The regulatory requirements are going to include CDISC in the near future and the benefits are obvious. It is therefore wise and prudent to implement with techniques and processes refined from lessons learned based on real life implementations.

CDISC standards have been in development for many years. There have been structural changes to the recommended standards going forward from version 2 to 3. It is still an evolving process but it has reached a point of critical mass that organizations are recognizing the benefits of taking the proposed standard data model out of the theoretical and putting it into real life applications. The complexity of clinical data coupled with technologies involved can make implementation of a new standard challenging. This paper will explore the pitfalls and present methodologies and technologies that would make the transformation of nonstandard data into CDISC efficient and accurate.

It is important to have a clear vision of the processes for the project before you start. This provides the ability to resource and plan for all the processes. This is an important step since the projects can push deadlines and break budgets due to the resource intensive nature of this effort. The organization and planning for this undertaking can become an essential first step towards an effective implementation.

SAS Cluster SAS Grid Cluster SAS Grid SAS SAS Cluster System SAS Cluster Servers SAS Grid Computing SAS Plugin for MS Office SAS MS Office Plugin SAS Plugin for Excel SAS Plugin for MS Word SAS Excel SAS MS Word SAS Macro Interfeace for MS Office Generate Reports from CDISC Data SDTM Reports ADaM Reports Standard SAS Reports SAS Program Library SAS Macro Library CDISC Course CDISC Class SDTM Course SDTM Class CDISC Training CDISC Implementation Training CDISC Implementation Class MedDRA Training MedDRA Class WHO Drug Training WHO Drug Class AE Coding Training AE Coding Class Drug Coding Class Drug Coding Training DEFINE.PDF Training DEFINE .XML Training Domain Documentation Training Domain Documentation Class Data Definition Training Data Definition Class SAS Validation Training SAS Validation Class SAS System Validation Training SAS System Validation Class SAS Program Validation Training SAS Program Validation Class SAS Macro Training SAS Macro Class User Friendly SAS Macro Course User Friendly SAS Macro Training Programming Macro Training Programming Macro Class SAS Excel Course SAS Excel Training SAS MSOffice Course SAS MSOffice Training SAS MSWord Training SAS MSWord Course Change Control Training SAS Change Control Training SAS Program Change Control Training SAS Macro Change Control Training SAS Change Control Class SAS Program Change Control Class MedDRA Coding WHO Drug Coding MedDRA Coding Service WHO Drug Coding Service MedDRA Service WHO Drug Service Thesaurus Dictionary Management ADaM ADaM Consulting ADaM Service Analysis Datasets Analysis Datasets Consulting Analysis Datasets Service Annotated Case Report Form Annotated Case Report Form Consulting Annotated Case Report Form Service Annotated CRF Annotated CRF Consulting Annotated CRF Service Biostatistics Consulting Biostatistics Service CDISC ADAM CDISC ADAM Consulting CDISC ADAM Service CDISC Compliance CDISC Compliance Consulting CDISC Compliance Service CDISC SDTM CDISC SDTM Consulting CDISC SDTM Service Clinical Data Management Clinical Data Management Consulting Clinical Data Management Service CRF Design CRF Design Consulting CRF Design Service Data Management Service Design Case Report Form Design Case Report Form Consulting Design Case Report Form Service Discrepancy Management Discrepancy Management Consulting Discrepancy Management Service Edit Checks Edit Checks Consulting Edit Checks Service Electronic Submission Electronic Submission Consulting Electronic Submission Service SAS Consulting SAS Development Consulting SAS Development Service SAS Program Consulting SAS Program Service SAS Service SDTM Consulting SDTM Service Statistical Consulting Statistical Service Tables Listings and Graphs Tables Listings and Graphs Consulting Tables Listings and Graphs Service TLG Consulting TLG Service Coding Methodologies Contract Research Organizations CRO Data Library Managing Thesaurus Reconciling Dictionaries SAS Macros Table of Contents TOC Biostatistics Case Report Form Case Report Form Design Case Report Form Service CFR part 11 Clinical Data Management CRF Tabulations Custom Database Custom Database Consult Custom Database Design Custom Database Service Data Analysis Data Management Data Warehouse Design Clinical Plans Electronic case report Electronic submission FDA Submission IND Medical Device Medical Writing Ndas Prepare Patient Profile Consult Patient Profile Generator Patient Profile Service RFP SAS Consulting SAS Service SOP Consulting SOP Service Code Optimizer Data Models Data Standards Data Definition Define.xml Define.PDF Domain documentation Data Definition Documentation Coded Terminology Coded Terminology Management Coded Terminology Software SAS Format SAS Format Management CDISC Coded Terminology Coded Terms Coded Terms Coded Terms Software Controlled Terminology Control Terminology Controlled Terminology Management Control Terminology Management Control Terminology Software Controlled Terminology Software CDISC Controlled Terminology CDISC Control Terminology SAS Data Viewer Data Viewer Syview View SAS without lock SAS Dataset Viewer SAS Dataset View SAS Data View Generate Reports from CDISC Data SDTM Reports ADaM Reports Standard SAS Reports SAS Program Library SAS Macro Library