CDASH : A PRIMER AND GUIDE TO IMPLEMENTATION

• Content Standard NOT a Model • Covers 22 core Case Report Forms CRFs - Variable Names, Definition, Question Text - Instructions to the Site, SDTM Variable Mapping • Core Designations

CDASH : A PRIMER AND GUIDE TO

• Introduction

• What is CDASH? What it is not

• Perfect libraries with CDASH

• CDASH with multi-EDC vendors

• CDASH aids mapping to SDTM

• Practical CDASH mapping examples

• Conclusions

AGENDA

• Vendor neutral using CDISC since 2000

• Save time & money in End-to-End Clinical Trial

• Universal Design with Formedix Origin™

• Data Acquisition Design & Dataset Design

• Origin Study and Submission Modeller™

• Universal Execution with Formedix Transform™

• Data Acquisition – Paper, EDC, ePRO & IVRS

• Conversion – ETL

• Submission – Annotated CRF and Define.pdf

• Create once work with all Train in one work in all

• Formedix Consult™ Consultancy Services

• Planning, preparation, implementation, multi-EDC execution

• Won 2 CDISC awards – wrote much of ODM/define INTRODUCTION

INTRODUCTION

TO CDASH

• Content Standard NOT a Model

• Covers 22 core Case Report Forms (CRFs)

- Variable Names, Definition, Question Text

- Instructions to the Site, SDTM Variable Mapping

• Core Designations is a killer feature

- Give clinical context on why something is collected

- Highly recommended, recommended/conditional, optional

- Clinical Perspective on data collection

• What it is not

- One-to-one mapping with the SDTM

- AEYN not in SDTM, AEBODSYS not in CDASH WHAT IS CDASH? WHAT IT IS NOT

• Excel, Word, PDF Libraries

- Excel for database metadata

- Word for CRF mock-ups

• Global proprietary EDC Library

- Rave, DataLabs, Prism…

- Has shortcomings

◦ Lack of full support for CDISC

◦ No alias support – automate aCRFs

◦ No discrete measurement units support

◦ Poor support for vertical structures

• Optimal solution CDASH in CDISC-ODM

HOW CAN CDASH BE STORED?

WHAT IS CDASH ODM?

Submission

Codelists

Extended ODM Structure

Database Content and Structure Clinical Context

• Libraries – Content Reuse

- 70% reuse

- Standards maintenance resources down by 23%

- Just this use case ROI – 8 months

• Study Set-up

- Specification auto-generation

- Boston Scientific proved a 68% reduction

- With CROs, Partners, EDC vendors …

• Study Build

- Automate EDC build build

- 55% reduction in EDC build

• Study Conduct and Analysis

- 76% reduction in dataset production

CDISC SAVES TIME & MONEY

PERFECT LIBRARIES WITH CDASH

CASE STUDY - CDASH NOT USED

8

STUDIES

IN SAME THERAPEUTIC AREA

MIXTURE OF EDC/CRO VENDORS

342

FORMS

143

UNIQUE FORMS

Multiple permutations of Forms present

15

VITAL SIGNS FORMS

6

PHYSICAL EXAM FORMS

36

FORMS WITHOUT CDASH

4

MASTER LIBRARY FORMS WITH CDASH

• Use study 1 as a library

• Add each ‘new' form from study

to study

• Do not standardize

• End-to-end reuse low until final studies

CRF REUSE BEFORE & AFTER

• Standardize common forms

Percentage Reuse % Reuse

%Reuse CDASH

CDASH LIBRARY –

MASTER DEMOGRAPHICS EXAMPLE STUDY SPECIFIC DEMOGRAPHICS

• Quality is built in up-front not tested in

• CDISC Libraries with CDASH Content

- Clinical context – quicker clinician approval

- Vendor neutral and portable

• Design once

- Everything pre-approved so review reduced

- Only test new content or changed content

- Standardized CRFs = consistent data collection

- Standardized CRFs = standardized datasets/mappings

• Reuse of all study design components

- Across end-to-end clinical trial

- Across multiple vendors & data capture systems

CDISC MODELS AND CDASH CONTENT

PERFECT REUSE EVERYWHERE

CDASH WITH

MULTI-EDC VENDORS

CDASH MULTI-VENDOR eCRFS AUTOGENERATED

• Structural Issues

- CDASH vertical vs EDC horizontal

- EDC systems allow only one vertical structure

• Poor/Lack of support for

- CDISC identifiers - lengths, character restrictions etc

- Aliases – used to annotate/map to SDTM, Legacy fields

• Structural

- Implement one field per question (horizontal)

- Implement vertical versions

- Split repeating sections on separate forms (incl/excl)

• Core Libraries

- Covers most use cases

- Special case specific EDC eCRFs in separate library

• Global aliases

- Company corporate identifiers used end-to-end everywhere

- Still supports EDC identifier restrictions

• Code / decode instead of enumerated codelist

IMPLEMENTATION ISSUES -

SOLUTIONS

MAPPING CDASH

TO SDTM

ADVANTAGES OF CDASH

• Interventions

- CM (Concomitant Medications)

- LB (Laboratory Test Results)

DOMAINS MAP TO CDASH

CDASH ODM

CDASH & SDTM ALIGNMENT

CDASH CRF Label Question

SDTM Controlled Terminology

SDTM Variable Name

CDASH Core (Highly

Recommended)

OPTIMIZING DOWNSTREAM DATAFLOWS

OPTIMIZING DOWNSTREAM DATAFLOWS

• Vital signs (VS form)

• Vertical implementation suggested

• Optimized for dataset production

and not all easy to enter data

• Must repeat on VSTEST

- Cannot have repeat on time as well

- Form repeats for time points

• Other issues

- Every variable collected at every time

point even if likely to remain constant

- VSORRESU Units must be a pull down

- Error prone needs more edit checks

- Repeated collection of irrelevant values

• Pros: Simple dataset mapping

PURE CDASH :

VERTICAL NEEDS HELP SOMETIMES

79 SDTM DATASET

• CDASH ODM is best format to store CDASH

- Union of all standards

- SDTM, ODM, CT

- EDC extensions and best practices

• CDASH saves time and money

- Clinical perspective

- Promotes reuse of CRFs and end-to-end designs

- Alignment with SDTM and mapping ease

• Compromises have to be made

- Multi-vendor and your own content

- No two CDASH libraries are identical

CONCLUSIONS

ANY QUESTIONS?