Communicating with Standards

Keeping it SimplePamela Ryley

Vertex Pharmaceuticals, Inc.September 29, 2006

Pamela Ryley 29 Sept 2006

Implementing CDISC

Why?

What Point in Study to apply CDISC Preparation for submission Database extraction Data collection / Database creation

STDM – OkayWhat about the rest of CDISC?

Trial Design, ADaM, LAB Model

Pamela Ryley 29 Sept 2006

Concurrent Changes

New Electronic Data Capture system New Electronic Reporting and Repository

system New Standards - CDISC

Opportunity to determine where to implement CDISC

Push CDISC strategy back to data collection – data collection items being redefined anyway.

Pamela Ryley 29 Sept 2006

Implementing STDM in Data Collection

Identifying and implementing the use of one to one matches

Implementing logical naming and structure where one to one matches not possible.

Identifying limitations of chosen EDC database and preparing for those.

Pamela Ryley 29 Sept 2006

Implementing STDM in Data Collection

Collection variables to reporting variables

eCRF Data Controlled terminology Electronically loaded data

Efficiency and Reduced Cost

Pamela Ryley 29 Sept 2006

Implementing STDM in Data Collection

Close collaboration between Data Management, Statisticians and Statistical Programming to streamline processing from data capture to reporting.

Education and acceptance of other groups.

Recognition of need and willingness to replace earlier standards

Pamela Ryley 29 Sept 2006

Challenges of Implementing STDM in

Data Collection

Items without a one to one correlation Variables that require transposition Items collected for operational use Greater detail than required by CDISC

Submissions to other agencies Exploratory use or Publication Items of Operational Value

Pamela Ryley 29 Sept 2006

Extending the Implementation

Legacy data Mapping

Variables One to many Many to One

Controlled Terminology Add Trial Design Datasets

Pamela Ryley 29 Sept 2006

Extending the Implementation Increases ability to easily combine

data across protocols early in compound development.

Creation of updated set of standard programs that take advantage of features in SAS version 9.

Pamela Ryley 29 Sept 2006

Confirming Structure

General Conformance SAS v9 Proc CDISC Web SDM

Combining data across protocols Combining legacy and current data

Data as required Structure & Content

Pamela Ryley 29 Sept 2006

Programming

Benefits of Pushing CDISC standards to data collection

Minimize preparation of submission datasets

Time Resources used for more valuable endeavors Consistency & Transparency

Pamela Ryley 29 Sept 2006

Risks of Implementing CDISC in Data Capture

Changes to CDISC New domains

Modifications to Draft Domains Modifications to controlled terminology

Broader Limitations SAS V5 Transport files xml files 8 character limitations on numerous variables

Changes to Trial Design, ADaM, LAB Model

Pamela Ryley 29 Sept 2006

Challenges

Trial Design Datasets Reserved domains Determining when to use supplemental

qualifiers versus creating new domains Complex Design of Protocols – difficult to

fit into CDISC standards No single source for answers to questions.

We do have user groups

Pamela Ryley 29 Sept 2006

Thank You!