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Dear RTP CDISC members,
The next meeting of the RTP CDISC User's Group will be held next week.
The next meeting of the RTP CDISC User's Group will be held next week.
When: June 14th, 2006 from 2:00 to 4:45.
Where: SAS Institute, Building F, Room 202
Please RSVP to: Frank@...
Please note: Attendees are required to stop at the guard booth at the main SI entrance. If you're on the RSVP list, the guard will check your name off and give you directions. If you are NOT on the list, tell the guard you're attending the CDISC meeting and tell him/her that David
Handlesman is the meeting contact person.
The meeting will focus on two key concepts and tools for
developing CDISC-compliant submissions: metadata and PROC CDISC.
Agenda
==================
** Welcome **
The Design and Use of Metadata: Part Fine Art, Part Black Art
- Frank DiIorio, CodeCrafters, Inc. and Jeff Abolafia, Rho Inc.
The complexity of even small pharmaceutical projects can be
daunting. Consider the deliverables: patient profiles, listings,
domain and analysis data sets, Define files, tables, and figures.
Even in a single study, these routinely total hundreds of files.
For NDA submissions, these are but a single piece of a larger
“puzzle.”
Consider as well the documentation and human resources pushing
the study through its life cycle. Project managers need to
monitor the completion status of the files. Statisticians and
analysts have to identify data requirements and lay out “dummy”
displays. Programmers have to write the programs to create the
data and reports using specifications that are often, to be kind,
“fluid.” Creation of high-quality output requires coordination of
effort and clear and immediate communication of results. Rho has
migrated much of the requisite project management and data and
display specifications to carefully designed and utilized
metadata. By moving items that describe data sets and displays
from documents and low-level programs into data sets, we have
realized significant gains in productivity and quality of output.
This paper describes the current use of metadata at Rho. It:
o Discusses the motivation for using metadata
o Describes the metadata architecture
o Identifies tools that access the tables
o Presents examples, comparing metadata and non metadata-driven programs
The paper is largely conceptual and nearly code-free. While we
emphasize application development in the pharmaceutical industry,
we feel the underlying concepts regarding metadata design and
implementation are valid across industries.
** Break **
An Introduction to PROC CDISC
- Anthony Friebel, SAS Institute
(formal abstract not available) When accepting our invitation to
present at the meeting, Tony said he would cover several topics:
a shortCDISC standards overview, a discussion of the ins and outs
of PROC CDISC, followed by a live demo of the PROC and time for
questions. The new version of PROC CDISC will generate a CDISC-
compliant Define.XML file, which segues nicely into the third
part of the meeting ...
Define File Panel Discussion
Panelists will discuss their experiences creating the all-
important "Define" file. There will probably be at least as many
approaches to this task as there are presenters, so should be
be a valuable overview.
Speaker Bios
============
Jeff Abolafia is currently the head of the Submissions Department
at Rho, Inc. Previously Jeff was a member of the faculty in the
Department of Biostatistics at the University of North Carolina
at Chapel Hill, as well as, the Director of the Statistical
Computing Division at the Collaborative Studies Coordinating
Center. Jeff has used SAS for over twenty-five years and is the
author of several SUGI/SESUG papers. His areas of interest
include electronic submissions, clinical trials, statistical
computing, and research data management.
A SAS programmer since 1975, Frank DiIorio is President of
CodeCrafters, Inc. and the author of "SAS Applications
Programming: A Gentle Introduction" and "Quick Start to Data
Analysis with SAS." He is past President of the SouthEast
SAS Users Group, and co-chaired its 1994 and 1996 conferences. A
native New Yorker, he has lived in Chapel Hill, North Carolina
since 1974 and believes its claim to being the "Southern Part of
Heaven."
Anthony “T” Friebel is a more than twenty-five years veteran of
computing disciplines and is the XML Strategist for SAS Platform
R&D. He has been a participating member of the CDISC working
groups since 1999, is the 2005 ODM Team Outstanding Achievement
award winner, was a principal contributor on the CDISC CRT-DDS
(aka define.xml) standard, and is a technical member of the
ADaM/SDTM Pilot project team.
The meeting will focus on two key concepts and tools for
developing CDISC-compliant submissions: metadata and PROC CDISC.
Agenda
==================
** Welcome **
The Design and Use of Metadata: Part Fine Art, Part Black Art
- Frank DiIorio, CodeCrafters, Inc. and Jeff Abolafia, Rho Inc.
The complexity of even small pharmaceutical projects can be
daunting. Consider the deliverables: patient profiles, listings,
domain and analysis data sets, Define files, tables, and figures.
Even in a single study, these routinely total hundreds of files.
For NDA submissions, these are but a single piece of a larger
“puzzle.”
Consider as well the documentation and human resources pushing
the study through its life cycle. Project managers need to
monitor the completion status of the files. Statisticians and
analysts have to identify data requirements and lay out “dummy”
displays. Programmers have to write the programs to create the
data and reports using specifications that are often, to be kind,
“fluid.” Creation of high-quality output requires coordination of
effort and clear and immediate communication of results. Rho has
migrated much of the requisite project management and data and
display specifications to carefully designed and utilized
metadata. By moving items that describe data sets and displays
from documents and low-level programs into data sets, we have
realized significant gains in productivity and quality of output.
This paper describes the current use of metadata at Rho. It:
o Discusses the motivation for using metadata
o Describes the metadata architecture
o Identifies tools that access the tables
o Presents examples, comparing metadata and non metadata-driven programs
The paper is largely conceptual and nearly code-free. While we
emphasize application development in the pharmaceutical industry,
we feel the underlying concepts regarding metadata design and
implementation are valid across industries.
** Break **
An Introduction to PROC CDISC
- Anthony Friebel, SAS Institute
(formal abstract not available) When accepting our invitation to
present at the meeting, Tony said he would cover several topics:
a shortCDISC standards overview, a discussion of the ins and outs
of PROC CDISC, followed by a live demo of the PROC and time for
questions. The new version of PROC CDISC will generate a CDISC-
compliant Define.XML file, which segues nicely into the third
part of the meeting ...
Define File Panel Discussion
Panelists will discuss their experiences creating the all-
important "Define" file. There will probably be at least as many
approaches to this task as there are presenters, so should be
be a valuable overview.
Speaker Bios
============
Jeff Abolafia is currently the head of the Submissions Department
at Rho, Inc. Previously Jeff was a member of the faculty in the
Department of Biostatistics at the University of North Carolina
at Chapel Hill, as well as, the Director of the Statistical
Computing Division at the Collaborative Studies Coordinating
Center. Jeff has used SAS for over twenty-five years and is the
author of several SUGI/SESUG papers. His areas of interest
include electronic submissions, clinical trials, statistical
computing, and research data management.
A SAS programmer since 1975, Frank DiIorio is President of
CodeCrafters, Inc. and the author of "SAS Applications
Programming: A Gentle Introduction" and "Quick Start to Data
Analysis with SAS." He is past President of the SouthEast
SAS Users Group, and co-chaired its 1994 and 1996 conferences. A
native New Yorker, he has lived in Chapel Hill, North Carolina
since 1974 and believes its claim to being the "Southern Part of
Heaven."
Anthony “T” Friebel is a more than twenty-five years veteran of
computing disciplines and is the XML Strategist for SAS Platform
R&D. He has been a participating member of the CDISC working
groups since 1999, is the 2005 ODM Team Outstanding Achievement
award winner, was a principal contributor on the CDISC CRT-DDS
(aka define.xml) standard, and is a technical member of the
ADaM/SDTM Pilot project team.
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