"Overnight" Conversion to SDTM Datasets mathiesen & - - PowerPoint PPT Presentation

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"Overnight" Conversion to SDTM Datasets mathiesen & - - PowerPoint PPT Presentation

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Simplicity without Compromise "Overnight" Conversion to SDTM Datasets mathiesen & mathiesen AG fr informatik Simplicity without Compromise Why CDISC / SDTM ? FDA is strongly encouraging sponsors to submit data in standard

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Simplicity without Compromise

mathiesen & mathiesen

AG für informatik

"Overnight"

Conversion to

SDTM Datasets

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Simplicity without Compromise

Why CDISC / SDTM ? FDA wants SDTM

FDA is strongly encouraging sponsors to submit data in standard form as a key part of its efforts to continue with advancement of review efficiency and quality.* *CDER Common Data Standards Issues Document, May 2011

mathiesen & mathiesen

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Simplicity without Compromise

SDTM Manually or ....

Automated "Overnight" - cost efficient and you get SDTM for "free"

Clivax is designed for both

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  • 1. Your eCRF generates SDTM
  • 2. Conversion from Your Legacy Data
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Source: Dave Iberson-Hurst, CDISC

Infrastructure

Simplicity

FDA

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  • 1 Appl.

Clivax

  • 5 Applications
  • Setup

16 Weeks

  • 1 Day
  • SDTM

Mapping

  • Legacy

Converting

1.5 Man year

  • 7 Days

Without IT Specialists

100% Browser Based

  • "Free"

Not necessary

Simplicity

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Simplicity without Compromise

Legacy Data SDTM Conversion Project

Rawmaterials with 500.000 data points. Source Oracle System. Format SAS. Final SDTM Datasets 177.000 data points. 18 Domains. 7 Supp Domains.

mathiesen & mathiesen

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Simplicity without Compromise

Independent Clinical Research Consulting ICRC-Weyer GmbH, Berlin Specialist in CDISC / SDTM

Cooperation

CRO: mathiesen & mathiesen AG, Basel Developer of CLIVAX Software:

mathiesen & mathiesen

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Simplicity without Compromise

Legacy Data / SAS

mathiesen & mathiesen

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Simplicity without Compromise

SDTM Data / XML

Domain EG and SuppDomain SUPPEG

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Simplicity without Compromise

SDTM

Domain and Suppdomain

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Simplicity without Compromise

5 Conversion Steps (Without Programming)

  • 1. Define Study
  • 2. Import Raw Data
  • 3. Assign Issues
  • 4. Integrate Assigned Data in System
  • 5. Use Share, Domain

Legacy Data

Study Structure Analysis Export SDTM

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Simplicity without Compromise

Study Structure Analysis I

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Simplicity without Compromise

Study Structure Analysis II

Working Documents XLS Domains and SuppDomains

ECG Electrocardiography

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Simplicity without Compromise

5 Conversion Steps (Without Programming)

  • 1. Define Study
  • 2. Import Raw Data
  • 3. Assign Issues
  • 4. Integrate Assigned Data in System
  • 5. Use Share, Domain

Legacy Data

Study Structure Analysis Export SDTM

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Simplicity without Compromise

1.1 Define Study

mathiesen & mathiesen

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Simplicity without Compromise

1.2 Study Assign to CDISC

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Simplicity without Compromise

1.3 CDISC / SHARE Activate

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Simplicity without Compromise

5 Conversion Steps (Without Programming)

  • 1. Define Study
  • 2. Import Raw Data
  • 3. Assign Issues
  • 4. Integrate Assigned Data in System
  • 5. Use Share, Domain

Legacy Data

Study Structure Analysis Export SDTM

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Simplicity without Compromise

  • 2. Upload / Import Raw Data
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Simplicity without Compromise

5 Conversion Steps (Without Programming)

  • 1. Define Study
  • 2. Import Raw Data
  • 3. Assign Issues
  • 4. Integrate Assigned Data in System
  • 5. Use Share, Domain

Legacy Data

Study Structure Analysis Export SDTM

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Simplicity without Compromise

  • 3. Assign Issues
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Simplicity without Compromise

3.1 Assign Domain

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Simplicity without Compromise

3.2 Assign Visits

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Simplicity without Compromise

5 Conversion Steps (Without Programming)

  • 1. Define Study
  • 2. Import Raw Data
  • 3. Assign Issues
  • 4. Integrate Assigned Data in System
  • 5. Use Share, Domain

Legacy Data

Study Structure Analysis Export SDTM

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Simplicity without Compromise

  • 4. Integrate Assigned Data in System
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Simplicity without Compromise

5 Conversion Steps (Without Programming)

  • 1. Define Study
  • 2. Import Raw Data
  • 3. Assign Issues
  • 4. Integrate Assigned Data in System
  • 5. Use Share, Domain

Legacy Data

Study Structure Analysis Export SDTM

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Simplicity without Compromise

5.1 Use Share, SDTM Domain Structure

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Simplicity without Compromise

5.2 Assign SDTM Parameters

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Simplicity without Compromise

5.3 Assign SDTM Parameters II

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Simplicity without Compromise

5.4 SDTM / Supplement Domain - Bind

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Simplicity without Compromise

5.5 SDTM / Interpretation - QVAL

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Simplicity without Compromise

5.6 SDTM / QLABEL, QORIG, QEVAL

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Simplicity without Compromise

5 Conversion Steps (Without Programming)

  • 1. Define Study
  • 2. Import Raw Data
  • 3. Assign Issues
  • 4. Integrate Assigned Data in System
  • 5. Use Share, Domain

Legacy Data

Study Structure Analysis Export SDTM

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Simplicity without Compromise

6.1 SDTM Deliver / Export

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Simplicity without Compromise

6.2 SDTM Deliver / Export

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Simplicity without Compromise

Data obtained as "native" as possible

(from the eCRF structure retained)

Data cleaning from a high quality Unique parameter names makes life easier

(according to the CDISC philosophy)

Legacy Data SDTM

Source of related data from the same SAS table

(avoid mixing domains)

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Experience / Optimizing

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Simplicity without Compromise

  • 1. Speed up the Clinical Trial Process
  • 2. SDTM ready before "Start" of Data Input
  • 3. SDTM always "Included" and "Free" of charge
  • 4. All managed by your Clinical Trial team
  • 5. Without IT Specialists

Legacy Data SDTM ("Overnight")

Clivax delivers SDTM

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Simplicity without Compromise

www.clivax.com Peter Merian-Strasse 45

mathiesen & mathiesen

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niels.mathiesen@m-m.ag 4002 Basel

+41 61 271 69 42

Questions and Contact

You will find us at

Stand Number 17