How to deal with data from local labs

© 2010 PAREXEL International | Confidential

Laboratory Data Transfer with SDTM to the LB
domain

• Overview of topics:

• Challenge getting lab results into LB

• SDTM Requirements
• Data provided by Central Laboratories
• Data provided by Local Laboratories

• Standardized units

• Conversion factors

• Non-Convertible Units

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SDTM Requirement

• The task: beside the original result and original unit coming from the
DB add
• LBTESTCDs when the lab test is not part of the CT
• Original ranges
• You need ONE standard unit per lab parameter
• Standardized section, including
• Converted result (if the standardized unit is different to the original unit)
• Standardized unit
• Converted ranges (if the standardized unit is different to the original unit)
• Reference range identicators
• Test methods and other supplemental information

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Variable Conversion

•Need to convert all data from Original to Standard

Original Variable Standardized Variable

LBSTRESC
Results LBORRES
LBSTRESN

Units LBORRESU LBSTRESU

LBORNRLO LBSTNRLO
Ranges LBORNRHI LBSTNRHI

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Data provided by Central Laboratories

• Central Laboratories are normally uncomplicated

• Standardized exports from their database

• Normally already only a single unit per test

• Ranges attached to values consistent with the timepoint of the test

• Reference range identicators in place

• Additional information often given

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Data provided by Local Laboratories

• Local Laboratories are a challenge:

• Result and unit entered in CRF, Ranges often collected separately

• Every site could have their own unit per lab parameter

• Conversion of „local“ unit to selected „standard“ unit needed

• Define conversion factors per original unit which is different

• Variability of syntax of local units

• This includes similar units such as g/L == mg/mL

or semantic differences such as x10^6/L == 10E6/L == 10^6/L

• Use of „other unit“ fields

• Both original and standard unit must be mapped to Controlled Terminology

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Example for Multiple Units per Parameter

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Data provided by Local Laboratories (2)

• Need to collect the ranges per investigator per lab parameter

• Need to collect each range per gender and age of the subject

• Ranges have to be consistent with the unit of the value

• Ranges sometimes are valid only for a period - have to be updated

• Ranges may be from their lab, but they may have other references.

• Inconstitencies between result units and range units possible

• Data validation necessary for results out of range

• Investigator assessments must be included

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Data provided by Local Laboratories (3)

• Other interesting things that could happen…

• The site changes the unit and/or ranges from visit to visit per subject

• Typos of units which has been entered per hand

• Do you know „LAKHS/CMM“ ?

• Handle exotic local units – and find conversion factors

• Identify the meaning for some abbrivated units

• You have to spend lots of resources to get the local lab part into a good shape

• Paper CRFs are much harder to handle than eDC eCRFs

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Standardized units

• You need ONE standard unit per lab parameter

• Who determines this standard unit?

• There is no library to check for the correct unit per parameter

• Only for some lab parameter a „SI unit“ is defined

• Often a misunderstanding between „SI unit“ and „standardized unit“

• Different terms and syntax for the same unit

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Standardized units (2)

• Sponsor defined the standard unit for „his“ submission

• Standard Unit must be defined -> sponsor specific

• often SI where available, but might be protocol or CRF driven as well

• Not all sponsors have such standardized unit per lab parameter
=> some times „standardized unit” per study

• Another problem: use of the same LBTEST for different LBCATs

• E.g. Glucose (GLUC) for Chemestry and Urinalysis

• Should the same LBTESTCD/LBTEST for the different categories?

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Conversion factors

• Same problems and questions

• Who determines this conversion factors?

• There is no library to check for the correct conversion factors

• Need to validate each conversion factor

• Has to be hardcoded in the transfer program

• New data could mean: update of transfer program - because of new units

• Has to be used for values and ranges

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What would make our life easier…

•General consideration: each sponsor should have a lab model defined,

e.g. a library, that defines…

• LBTESTCDs for non-CT lab parameter

• Laboratory categories for each lab test (need a concept of categorizing tests)

• Standardized units per lab parameter

• Conversion factors

•Question: is there a need to create such library within CDISC?

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Special Issue: Non-Convertible Units

• Check for mixture of absolute and relative results for one parameter

• e.g. Basophils: given in “X 10*9/L” and “%”

• There are two different SDTM CT entries for Basophils:

• absolute Basophils BASO
• relative Basophils/Leukocytes BASOLE

• Depending on the original unit use the correct LBTESTCD/LBTEST

• Never convert such values since these are two separate parameters

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Special Issue: Non-Convertible Units - Example

• Incorrect dataset
LBTESTCD LBTEST LBORRES LBORRESU LBSTRESC LBSTRESN LBSTRESU
BASO Basophils 0 % 0 0 X 10*9/L
BASO Basophils 0 % 0 0 X 10*9/L
BASO Basophils 1 PER 100 BLOOD CELLS 1 1 X 10*9/L
BASO Basophils 1 PER 100 BLOOD CELLS 1 1 X 10*9/L
BASO Basophils 2 PER 100 BLOOD CELLS 2 2 X 10*9/L
BASO Basophils 0.028 X 10*9/L 0.028 0.028 X 10*9/L
BASO Basophils 0.041 X 10*9/L 0.041 0.041 X 10*9/L
BASO Basophils 0.056 X 10*9/L 0.056 0.056 X 10*9/L

• Correct dataset
LBTESTCD LBTEST LBORRES LBORRESU LBSTRESC LBSTRESN LBSTRESU
BASOLE Basophils/Leukocytes 0 % 0 0%
BASOLE Basophils/Leukocytes 0 % 0 0%
BASOLE Basophils/Leukocytes 1 PER 100 BLOOD CELLS 1 1%
BASOLE Basophils/Leukocytes 1 PER 100 BLOOD CELLS 1 1%
BASOLE Basophils/Leukocytes 2 PER 100 BLOOD CELLS 2 2%
BASO Basophils 0.028 X 10*9/L 0.028 0.028 X 10*9/L
BASO Basophils 0.041 X 10*9/L 0.041 0.041 X 10*9/L
BASO Basophils 0.056 X 10*9/L 0.056 0.056 X 10*9/L

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It’s not only LB…

• This standardized requirement may occurs for all Finding Domains

• Everywhere using different units for one parameter check for issues
• e.g. VS domain:
• Temperature collected in °C and °F
• Weight collected in kg and lbs
• Height collected in cm and inch

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Thank you

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