SCDM 2017ANNUAL CONFERENCE

September 24-27 I Orlando

CDASH Metadata Builds with Multiple CRO / EDC Vendors - Efficient SDTM datasetsFred D. Bermont

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Agenda

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•Development of CDASH Metadata Standards using ODM

•Aligning with SDTM

•Process of Developing Study specific CDASH Metadata using

Standards

•Exporting ODM with XML extensions to load into Various EDC

systems

•Different Vendors / CROs

•What We Learned

Disclaimer

The views and opinions expressed in this presentation and on the following slides are solely those of the presenter and not necessarily those of Shire.

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A Need

Expanding Clinical Portfolio and Employee Base

Standards and Governance Structure

CDASH Standards

SDTMIG 3.1.2

SDTMIG 3.2

• Reduce Database Development

• 10-16 Weeks

• 6-8 Weeks

Expectation FDA would Mandate the Use of CDISC Standards in the Near Future

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A Want

Unique standards reviewed (and approved)

by Governance

Ensure all the unique forms were developed and were unlikely to

change

Meet internally with MDs and SMEs to ensure the

proper information

Develop SDTM Mappings for both Standard and Study specific forms

Deliver Standards

Quickly

Deliver As Much In-house As Possible Prior To DB Production

How This Was Done-3 Parts-

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Part 1:Development of CDASH standards

Metadata

•Commonly Used

•CDASH 1.1

•16 Domains

•Company Defined Needs

Set Up

•“SuperSet”

•No Forms

•Stored in ODM.XML format

•Subset for study

Visualizations

•Human readable

•DB Design Spec

•Subset Spreadsheet

Vendor Agnostic Specification

• How we developed our Standard Metadata– View from a Specification

ODM Version

• The backbone that runs this is ODM

Part 2:Using Standards in Study Development

• Standards Specialist would sit in with a Study Team during Study Development• Study Database build started once protocol was in final draft• Subset document

• Work with the Data Manager to implement the Standards that have been approved (Vitals/Lab/Demographics etc.)

• Study Specific Forms would be spec’d out with Standards in mind• Developed using CDASH “Model”

• Findings Domain• Event Domain• Intervention Domains

Data Manager uses Subset document to Specify Items from Standard Domains

Standards and DM meet with Study team to Define

Study Specific Forms

Standards Develops Study specific Forms with CDASH Model

Study Team Approves all

Unique Forms

Standards extends ODM for delivery

into EDC system via plug-ins

Delivery

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CRF Questions would be developed with Medical Monitor/Study Team

• Many Rare Disease concepts were "new". As a result questions were usually being asked for the first time

• Standards specialist “map to SDTM”• Annotations were created to facilitate

early review

Once all Unique CRFs were finalized, Standards Specialist and Study Team Clinical Biostats Programmer, would meet to review SDTM.

CDASH used, therefore ease of use to map raw data into

SDTM

Part 2: Using Standards in Study Development Continued

Part 3 - Delivery

RAVE

InForm

DataLabs

Vendor Agnostic

Specification

Vendor Confirms Upload

Vendor Develops from EDC Agnostic

Specification

Vendor gets study ready

for production

ODM-XML Stored

Extend usingFormedix Study Modeller

Plugs ins “transform” ODM to EDC uploads

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Part 3 – Delivery / Handoff

Source Data Verification

Univariate Edit Checks

Welcome and Save

Confirmation

Multiple EDC Specification

Company Specific QC Validations

As we got used to this process more and more metadata was added to the library to allow for

quicker Database Development

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What we Learned / Challenges

For the identified business needs at the time this process was highly successful.

• Reduced database development time from 10-16 to 6-8 with a couple studies hitting the 6 week or less.

• Cost of Database development went down 10%

• Quicker Database Development with less cost

Figured we could do 10-12 Databases a Year using this process with 1.25 FT resources.

We were able to do more Study Builds using this method than the previous method without Standards

Resistance: Not comfortable working with Superset, wanted Forms Library

CRO: Use their DB Specification, needed to convince to use ours

Metadata Library: Set up using Superset as to not overburden current staff.

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What we Learned

By using CDASH Metadata, the Biostats programming team could set up macros and other programming methods to develop SDTM datasets.

Using CDASH allowed for direct mapping in some cases to SDTM variables

Our standards were used 78% of the time which had major downstream effect

Able to leverage study specific forms for future study use

• Cut SDTM mapping time as most items were mapped up front.