Transcript STDM generation in Lundbeck

STDM generation in Lundbeck
- From Source to Target
H. Lundbeck A/S
17-Jul-15
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Agenda
• Background
• Architecture & Tools
• Design and Implementation of the
SDTM conversion framework
• Evaluation
• Plan for further delvelopement
• Questions/Discussion
H. Lundbeck A/S
17-Jul-15
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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/S
17-Jul-15
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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/S
17-Jul-15
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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/S
17-Jul-15
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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/S
17-Jul-15
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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/S
17-Jul-15
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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/S
17-Jul-15
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Architecture
SOURCE
TARGET
Rave
Repor
ting
Tool
Datafax
SAS-Di Studio
eDM/eDE
ETL Tool
SDTM
Interface
CROs
SADS
Partners
H. Lundbeck A/S
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Design and Implementation
• The shortest distance between two
points is a stright line:
A
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B
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Design and Implementation
• Divide the line into stages:
SOURCE
H. Lundbeck A/S
Stage 1
Stage 2
Stage 3
Stage 4
TARGET
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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/S
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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/S
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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/S
17-Jul-15
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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/S
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Design and Implementation
• Depictured with work-demanded
proportions:
Derive
Define
Stage 3
SOURCE
Stage 1
TARGET
Stage 2
Stage 4
Apply
H. Lundbeck A/S
17-Jul-15
Structure
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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/S
17-Jul-15
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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/S
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…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
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Thanks to …
• H. Lundbeck A/S
• Nordic CIDSC User Group
• Danish Association for Data Managers
H. Lundbeck A/S
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Questions/Discussion
?
H. Lundbeck A/S
17-Jul-15
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