© 2010 PAREXEL International | Confidential

An Introduction to SDTM

Laurent Marais

Sorcery and other approaches

An Introduction to SDTMAn Introduction to SDTM

22CONFIDENTIAL

Why SDTM?

• How does study data look?• What is wrong with this look?• What is the alternative?• How does the alternative look?• Why does it look like this?• What are the advantages?

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How does study data look?

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How does study data look?

• Study data typically suffers from:• Creative study design• A very thorough, micro managing sponsor

• Questions every decision made to simplify rest of study• Changes commonly used conventions

• Creative CRF design• Creative database design

• One piece of data stored in many fields• Many pieces of data stored in one field• Many different CRF panels to one dataset

• Creative data provided by the site

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What is wrong with this look?

• Nothing – beautiful to look at – very artistic• Can cause many phone calls from stats on a regular basis

– excellent to keep communications channels open• Protocol will be read a few times to understand how the

data relates to the study

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What is the alternative?

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What is the alternative?

• Sorcerers' Data Transfer Mechanism• Study Data Tabulation Model

• Study Data• Tabulation Model

• To arrange in tabular form • Condense and list.

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How does the alternative look?

• Standard domains• Standard fields

• Standard attributes (name, label, type and length)• Standard ways of representing data

• Standard terminology• Repeating terms and units in standard format

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1010

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How does the alternative look?VSTESTCD

VSTEST

VSPOS

VSORRES

VSORRESU

SYSBP Systolic Blood Pressure Sitting 154 mmHg

DIABP Diastolic Blood Pressure Sitting 44 mmHg

PULSE Pulse Rate Sitting 72 bpm

RESP Respiration Rate Sitting 12 BREATHS/MIN

TEMP Temperature 34.7 C

HEIGHT Height 157 cm

WEIGHT Weight 90.5 kg

ABC 001-001 BASELINE 1 1999-06-19 08:45 Sitting

STUDYID

SUBJID

VSSTAT

VSTPT

VSDAT

VSTIM

VSPOS

SYSBP

DIABP

PULSERESP

TEMP

HEIGHT

WEIGHT

154 44 72 12 34.7 157 90.5

VSTPT

BASELINE 1

BASELINE 1

BASELINE 1

BASELINE 1

BASELINE 1

BASELINE 1

BASELINE 1

VSDTC

1999-06-19T08:45

1999-06-19T08:45

1999-06-19T08:45

1999-06-19T08:45

1999-06-19T08:45

1999-06-19T08:45

1999-06-19T08:45

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Why does it look like this?

• No need to add additional fields• More information can be stored for each piece of

information • Unit• Standardized and numeric result• Is this the baseline value?• Normal range• Normal range indicator (High/Low/Normal)• Interpretation for this result (NCS/CS in SUPP)

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What are the advantages?

• Trial design clear • Easy to understand trial

• Standard way of representing the data• Data can be found where expected• Easy to analyze – standard terminology

• Standard software can evaluate the data• OpenCDISC Evaluator• Standard data validation implementations

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Questions

• How long does it take to map a study?• Depends on:

• Software used• Previously mapped studies• Experience• Study design• 1 day – 6 months

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Questions

• What are typical mistakes made?• Not all datasets transferred• Program logic drops records• Incorrect terminology• Visit / Time point structure inconsistent• Supplemental data does not refer to original• Expected / required fields missing

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Questions

• Where can the standard terminology be found?• It can be found at www.cdisc.org

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Questions

• Are there software available to simplify the mapping process?• Yes, commercial software packages are available• Custom solutions are also common in companies

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Questions

• How are mistakes picked up?• OpenCDISC Evaluator• Web SDM – Oracle (Phase Forward)• Data QC• Logical/functional QC by experienced person• Sorcery