Stdm generation in lundbeck from source to target
This presentation is the property of its rightful owner.
Sponsored Links
1 / 21

STDM generation in Lundbeck - From Source to Target PowerPoint PPT Presentation


  • 75 Views
  • Uploaded on
  • Presentation posted in: General

STDM generation in Lundbeck - From Source to Target. Agenda. Background Architecture & Tools Design and Implementation of the SDTM conversion framework Evaluation Plan for further delvelopement Questions/Discussion. Background. This is a presentation about:

Download Presentation

STDM generation in Lundbeck - From Source to Target

An Image/Link below is provided (as is) to download presentation

Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author.While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.


- - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - -

Presentation Transcript


Stdm generation in lundbeck from source to target

STDM generation in Lundbeck - From Source to Target

H. Lundbeck A/S15-Sep-141


Agenda

Agenda

  • Background

  • Architecture & Tools

  • Design and Implementation of the SDTM conversion framework

  • Evaluation

  • Plan for further delvelopement

  • Questions/Discussion

H. Lundbeck A/S15-Sep-142


Background

Background

  • This is a presentation about:

    • The considerations and experiences Lundbeck has had when implementing their SDTM conversion process

  • This a not a presentation about

    • Hardcore SAS macros

    • A detailed explaination of the SDTM data model.

H. Lundbeck A/S15-Sep-143


Background1

Background

  • The SDTM conversion project was initated and developed in 2007-2008 as a part of the Lundbeck eClinical program.

  • Started with one programmer under the supervision of a project lead.

  • Current status: the SDTM conversion process is rolled out in Line of Business (the CDO Department) and involves five programmers and one project manager

H. Lundbeck A/S15-Sep-144


Background2

Background

  • The goal was to implement a framework for converting any clinical study data (source) into an SDTM data format (target)

  • Benefits of framework:

    • Extend the use of industry standards (CDISC/SDTM) to the clinical data process flow

    • Eliminate data transformation / alignment both within and across studies and from external sources

    • Enable systematic and extensive use of current and historical data

    • Simplify data interchange with partners and regulatory authorities

H. Lundbeck A/S15-Sep-145


Background3

Background

  • Source data from four Rave studies were selected as the basis for the implementation of the framework

    • Lundbeck project LuAA21004, studies 11984A, 11984B and 11985A and Lundbeck project LuAA24530: study 11918A

H. Lundbeck A/S15-Sep-146


Background4

Background

  • The experiences from converting the first four studies will lay the basis for a Lundbeck SDTM data model

    • Domain definitions of all domains currently used in the SDTM conversion process

    • Convension rules /Algorithms

    • CDISC/Lundbeck Controlled Terminology

H. Lundbeck A/S15-Sep-147


Architecture

Architecture

  • Available tools for the SDTM conversion:

    • Clinical study data (a lot!)

    • An ETL-tool for data manipulation

    • The SDTM Implementation Guidelines version 3.1.1/3.1.2

    • CDISC Controlled Terminology

    • In-house experience of a previously SDTM conversion project (Gaboxadol)

H. Lundbeck A/S15-Sep-148


Architecture1

SDTM Interface

Rave

Reporting Tool

Datafax

eDM/eDE

ETL Tool

SOURCE

SAS-Di Studio

CROs

SADS

Partners

Architecture

TARGET

H. Lundbeck A/S15-Sep-149


Design and implementation

Design and Implementation

  • The shortest distance between two points is a stright line:

A

B

H. Lundbeck A/S15-Sep-1410


Design and implementation1

Design and Implementation

  • Divide the line into stages:

SOURCE

TARGET

Stage 1

Stage 2

Stage 3

Stage 4

H. Lundbeck A/S15-Sep-1411


Design and implementation2

Design and Implementation

  • Stage 1(Define):

    • Define the mapping from source to target

      • Annotate CRF according to the SDTM format

    • Implement the mapping

      • Build up data dictionaries (SAS format libraries)

        Example

H. Lundbeck A/S15-Sep-1412


Design and implementation3

Design and Implementation

  • Stage 2(Apply):

    • Apply the mappings to the source data

      • Apply the SAS user defined formats

    • Set the value of general variables

      • E.g. STUDYID, DOMAIN, VISIT, VISITNUM, VISITDY

        • A SAS macro library

H. Lundbeck A/S15-Sep-1413


Design and implementation4

Design and Implementation

  • Stage 3(Derive):

    • Derive standard values based on the original collected result(Relevant for the Findings Observation Class).

      • E.g. the variables --STRESC and STRESN and standard units in –STRESU

    • Derive other values.

      • E.g. the variables --DY, VSTESTCD=BMI, --SEQ

H. Lundbeck A/S15-Sep-1414


Design and implementation5

Design and Implementation

  • Stage 4(Structure):

    • Create the final structure on datasets

      • E.g. create the supplemental qualifiers domains.

    • Create the CO (Comments Domain)

    • Create the Trial Design Domains (TI, TE, TV,TS,TA)

H. Lundbeck A/S15-Sep-1415


Design and implementation6

Design and Implementation

  • Depictured with work-demanded proportions:

Derive

Define

Stage 3

SOURCE

TARGET

Stage 1

Stage 2

Stage 4

Apply

Structure

H. Lundbeck A/S15-Sep-1416


Evaluation

Evaluation

  • Evaluation of the benefits:

    • Extend the use of industry standards (CDISC/SDTM) to the clinical data process flow

    • Eliminate data transformation / alignment both within and across studies and from external sources

    • Enable systematic and extensive use of current and historical data

    • Simplify data interchange with partners and regulatory authorities

H. Lundbeck A/S15-Sep-1417


Further development

Further Development

  • Implement the WebSDTM validation checks

  • Development and implementation of a CDASH library

    • Greater transparency in the data flow

  • SDTM knowledge/experience sharing between companies (Network Groups)

H. Lundbeck A/S15-Sep-1418


And some memories

…and some memories

’Computer Charlie

er en helt almindelig mand

& han ta'r toget ind til City hver dag

gemmer sit ansigt så godt han ka'

bag et slør fra dagens første Havanna

han ligner til forveksling alle andre i kupé'en

der til gengæld ligner koksgrå lig

& sidder pænt på række som på bunden af en grav

mens station efter station bare suser forbi’

’I en blågrå kupe’ af C.V. Jørgensen

H. Lundbeck A/S15-Sep-1419


Thanks to

Thanks to …

  • H. Lundbeck A/S

  • Nordic CIDSC User Group

  • Danish Association for Data Managers

H. Lundbeck A/S15-Sep-1420


Questions discussion

Questions/Discussion

?

H. Lundbeck A/S15-Sep-1421


  • Login