Implementing CDASH standards into data

Implementing CDASH Standards Into Data Collection and Database DesignRobert Stemplinger ICON Clinical Research... Benefits of CDASHthe clinical trial process, have those standards propa

Implementing CDASH Standards Into Data Collection and Database Design

Robert Stemplinger ICON Clinical Research

Reasons for Using CDASH

Why CDASH?

• Desire to streamline / standardize CRF library and database structures

sponsor specific standards

Labs, ECG, etc.

(restructuring when necessary)

Statistical Analysis Plan

SDTM, ADaM, define.xml, TLGs

to Client and/or FDA

TLGs CDASH

CT CT

CT

Benefits of CDASH

the clinical trial process, have those standards

propagate through to the end

required for CRF/eCRF and database

development

structures to SDTM

Project Outline

– CRF design, database design

– Database design, database creation

– CDASH expertise, SDTM expertise, Controlled Terminology expertise

– Data Validation Specification / Edits

– Validation vested at the study level

Annotate Module to SDTM

Build Database Modules

Create DHC &

DVS

Program Edit Checks

Map/ Program

to SDTM Maintain Standards Documentation

Implementation

Implementation Challenges

field versus hard standard

– Getting people involved early in the process / thinking about the end of the process

• Incorporate highly recommended and recommended/Conditional fields

• Incorporate optional fields as needed

Implementation Challenges (4)

– Apply controlled terminology to CRF or map CRF text

to controlled terminology in the SDTM data sets

• Is controlled terminology “usable” in the field?

– Apply to CRF

CRF Development

CRF Design

– Clinical / Biostatistics included as needed

• Six month duration

• Paper / EDC layouts similar

• Did not use Data Collection Field text from CDASH to describe field

• Handful of domains required more than one “standard” template

• Optional templates created for a handful of domains

CRF Development Issues

• DM

– Subject Initials, AGE - EU Data Protection / Privacy

• MH

– Multiple Iterations / Versions

• No verbatim Description text, only body systems

– Multiple Iterations / Versions

• No verbatim Description text, only body systems

– Difficult to gain consensus on what should appear on the form

– Did not implement

CRF Completion Guidelines / Help Text

existing standards

Database Development

• Three month duration

• Did not use Data Collection Field text from CDASH to describe variables

– Defined very simplistic naming conventions for additional text fields required for EDC systems

• Utilized standard SDTM specification template to

populate other variable attributes

• Utilized data dictionaries, elements, DVGs to attach controlled terminology

Database Development Issues

Table Name Table Description Target Variable Target Label Data Type Length

DM_STD Demography STUDYID Protocol/Study Identifier $ 200 DM_STD Demography SITEID Site Identifier $ 200 DM_STD Demography SUBJID Subject Identifier $ 200

DM_STD Demography VISITNUM Visit Number BEST 8

DM_STD Demography VISDATC Visit Date (char) $ 200 DM_STD Demography INIT Subject Initials $ 200 DM_STD Demography DSSTDAT Consent Date DATE 8 DM_STD Demography DSSTDATC Consent Date (char) $ 200 DM_STD Demography BRTHDAT Date of Birth DATE 8 DM_STD Demography BRTHDATC Date of Birth (char) $ 200

DM_STD Demography ETHNIC_C Ethnicity (code) $ 200 DM_STD Demography S_ETHNIC Other Ethnic Group $ 200

Discussion of Results

– ~10-20% reduction in number of hours required to

develop CRF and database structures as compared

to four “similar” studies put into production without the use of these standard structures

CDASH Standards (hrs)

– All EDC platforms

– Limited implementation of controlled terminology

– ~32% reduction in number of hours required to create SDTM compliant data sets as compared to four

“similar” studies put into production without the use of these standard structures

CDASH Standards (hrs)

Future Enhancements / Challenges

– CDASH specific terminology

standard structures

Strength through collaboration.