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PGM Validation Plan

PROGRAM verification PLAN the data Analyst Group, Inc. Can help design an appropriate and cost-effective Quality Control program for your site. Introducing QC metric data to improve program verification performance.

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49 views10 pages

PGM Validation Plan

PROGRAM verification PLAN the data Analyst Group, Inc. Can help design an appropriate and cost-effective Quality Control program for your site. Introducing QC metric data to improve program verification performance.

Uploaded by

chsd
Copyright
© Attribution Non-Commercial (BY-NC)
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PPT, PDF, TXT or read online on Scribd
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Data Analyst Group, Inc.

Copyright 2007, All Rights Reserved


Inaccurate programming results can place both company
and patient at risk.

To protect both, the highest degree of SAS programming


results are offered here.

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The Data Analyst Group can help design an appropriate
and cost-effective quality control program for your
site.

What follows is a simple outline, stressing key points of


such a proposal.

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 Objectives of SAS quality control.
 Meeting objectives and the Risk Assessment Approach.
 Reviewing different program verification methods.

 Who does what: Roles and Responsibilities.


 Role of Biostatistician.
 Role of SAS developer programmer.
 Role of Quality Control programmer.

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Biostatistician creates specs then
Submits request

Interactive Process

SAS developer produces TLGs


Then submits verification request

Interactive Process

Quality Control programmer validates results

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 Stepwise description of program verification:
 Determine program verification methodology.
 Build SAS verification program.
 Compare verification results with SAS developer results.
 Resolve QC issues.
 Document verification results for each SAS program.
 Archive output and all SAS related programs.

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 Examples of good specifications:
 Statistical tables
 Listings
 Kaplan-Meir graphs
 Data analysis files

 Conclusions:
 Good specs = Good programming results

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 Introducing QC metric data:
 What is QC metric data?
 How does QC metric data relate to program verification?
 How is QC metric data collected?
 Use QC metrics to improve program verification performance.
 Use QC metric data to shorten QC verification times.
 Examples.

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 Provide QC training classes:
 ‘Keep It Simple Stupid,’ programming techniques.
 Writing re-useable SAS verification snippets of code.
 Standardizing QC programs.
 Developing verification macros.
 Identifying common ‘error types’ in TLG’s.

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Data Analyst Group, Inc.
[email protected]

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