CDISC Methodologies for FDA Sumission Papers

CDISC Methodologies for FDA Submission Papers

The following will list potential papers for considerations for the new section within WUSS.

Potential Papers

No	Author Name	Author Information	Paper	Status
1	Ted Guo, Ph.D.	U.S. Food and Drug Administration, Rockville, MD	Bells and Whistles for One-Line Text Box to Create a Smarter Where Clause Detecting and Investigating Drug-Induced Liver Injury During Clinical Trials SAS/AF Applications as Review Tools	Contact Wei Chang Raoul send Carey Wei contact Carey will contact Carey will make phone call
2	Sandra Minjoe	Genentech, Inc., South San Francisco, CA	Implementing CDISC When You Already Have Standards: A Case Study	No Show Declined
3	Ian Fleming	Genentech	The Second CDISC Pilot Project A Metastandard for Integrating Databases	Carey Email but no response yet. Raoul talked at SGF, and willing. Carey will make phone call
4	Carey Smoak	Carey Smoak, Roche Molecular Systems, Inc., Pleasanton, CA	Mission Possible: A Proposed SDTM Domain for the Medical Device and Diagnostic Industry	call himself.
5	Robert Stemplinger	ICON Clinical Research, Redwood City , CA	Case Study: Analysis and Metrics of End-to-End Legacy Data Conversions into SDTM, ADaM, and Define.xml A Toolkit for CDISC Implementation	Email Request on 4/24 Declined 4/30
6	Steven Michaelson	SimulStat Inc., San Diego, CA	CDISC: Pains and Pitfalls to Dataset Creation	No Show Declined
7	Fred Wood	Principal Consultant, Octagon Research Solutions	The CDISC Study Data Tabulation Model (SDTM): History, Perspective, and Basics	Potential Invited Carey will make phone call
8	Anna Kunina	CV Therapeutics	Integration of SDTM File Creation into Study Analysis: A Practical Approach	Email Request on 4/24 Has declined and not attending.
9	Clinton Brownley	Independent Consultant	BRIDGing CDASH to SAS: How Harmonizing Clinical Trial and Healthcare Standards May Impact SAS Users	Email Request on 4/24 Clinton confirmed 4/24 Sy will confirm make phone call Sent acceptance letter June 19
10a	Barrie Nelson First Amgen Choice			Raoul has talked Sy will make phone call. June 16: Sy to call
10b	David Edwards		The Submission Data File System - Automating the Creation of CDISC SDTM and ADaM Datasets	Raoul initial contact to Marcus but he declined. Not heard from David yet. Carey will make phone call Raoul.. then David June 16: Sy email Raoul to contact and ask David.
11	Diane Androvich Second Amgen Choice			Carey will contact
12	Li Zheng		Business Metrics for an End-to-End Legacy Data Conversion	Email Request on 4/24 Sy will make phone call June 16: Sy to call
13	Host: Sy Truong John Brega Patty Gerend Fred Wood Barrie Nelson Carey Smoak Robert Stemplinger Anna Kunina	Panel Discussion	Panel Discussion on Practical Hands on DEFINE.XML Examples	Sy will call after abstract Sy will email Raoul about registration wavier.
14a	Patty Gerend	Invited Speaker	CDISC Implementation on a Rheumatoid Arthritis Project Partnership	Email Request on 4/24 Sy will make phone call as invited Sent acceptance letter June 19
14b	Peggy Wooster			Carey will call Peggy declined 4/27

         Declined and no show
         Invited or prospective invited
         Confirmed
         To be emailed acceptance letter
         Already emailed acceptance letter

Tentative Schedule

Schedule	Author Name	Author Information	Paper
1:00 to 1:50	Carey Smoak	Carey Smoak, Roche Molecular Systems, Inc., Pleasanton, CA	Mission Possible: A Proposed SDTM Domain for the Medical Device and Diagnostic Industry
2:00 to 2:20	Clinton Brownley	Independent Consultant	BRIDGing CDASH to SAS: How Harmonizing Clinical Trial and Healthcare Standards May Impact SAS Users
2:30 to 3:20	Patty Gerend	Invited Speaker	Technical Considerations for End-to-End Conversion of Legacy Data Business Metrics for an End-to-End Legacy Data Conversion
3:30 to 4:30	Sy Truong (host) John Brega Patty Gerend Robert Stemplinger Anna Kunina Fred Wood Barrie Nelson Carey Smoak		Panel Discussion Panel Discussion on Practical Hands on DEFINE.XML Examples

last updated on June 16.2009