WG5 11JAN2012

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When: 08:00 , 11Jan2011
Place: TC
Facilitator: Scott Getzin
Scribe: Sally Cassells
Attendance:
Agenda: Introductions
Review Objectives
Brainstorm Charter Ideas

Introduction

Who's here?

Scott Getzin Lilly Sally Cassells Next Step Clinical Systems LLC Hamming Tu Octagon Research Joy Li FDA Mat Soukup FDA Mark Walderhaug FDA

Overview

Developed a list of topics for charter

Charter Topics

Developing standards for specifying analysis and validating them. (standards for analysis specs)

Standards for data transformations (standard ways for flip the data) or standards for documenting data transformations?

Standards ways to derive the data from SDTM or ADaM

New Analysis procedure – what is the information to describe what is going on… A process to registering analysis code, managing code, testing and publishing the code. And what is the metadata to describe the analysis code (inputs, outputs, derivations, processing)

Establishing core set of validation rules for SDTM and ADaM, and then specific rules for TA areas.

Perhaps establishing a library of algorithms (standard)?

Don’t what people using the scripts that they do not understand… Need to have them well described enough for them to understand

Follow up

Sally will draft charter based on brainstorming results.


Last revision by Scassells,02/20/2012