| PharmaSUG CN |
2026 |
DualBookmarker: A Python Tool to Create Dual Bookmarks for Annotated CRF |
Xianhua Zeng |
source |
4 |
| PHUSE US |
2026 |
CDISC 360i: From Vision to Implementation - Lessons Learned and the Road Ahead [presentation] |
Peter Van Reusel |
source |
23 |
| PHUSE APAC |
2026 |
CDISC 360i – Lessons Learned and Road Ahead [presentation] |
Peter Van Reusel |
source |
26 |
| PHUSE US |
2025 |
Automating SDTM Annotated CRF (aCRF) Creation |
David Postma, Christine Rossin |
source presentation source |
6 |
| PHUSE US |
2024 |
Data Handling through CDISC Standards in Master Protocols: A Focus on Rescreened and Re-Enrolled Subjects |
Swathi Kotla, Madhusudhan Reddy Papasani |
source presentation source |
7 |
| PHUSE EU |
2023 |
It's Easy Peasy Submitting Data to the China NMPA - Really? |
Nigel Montgomery, Chenkai Lv |
source presentation source |
10 |
| PHUSE EU |
2022 |
Do It Yourself: Case Report Form (CRF) Annotation |
Caro Sluijter |
source presentation source |
5 |
| PHUSE EU |
2022 |
SDTM Hackathon - To Find a Metadata-driven Software System that will Allow BMS to Automatically Generate Mapped SDTM Datasets [poster] |
Rashad Rasul, Nicole Thorne |
source |
1 |
| PharmaSUG |
2022 |
Automatic CRF Annotations Using Python |
Lijun Chen, Jin Shi, Tong Zhao |
source |
12 |
| PharmaSUG |
2022 |
eCOA and SDTM: Bring Order to the Wild West |
Vincent Allibone, Franklin E. Menius, Monali Khanna |
source |
8 |
| PHUSE US |
2021 |
China Center for Drug Evaluation, NMPA Electronic Study Data Submission Requirements [presentation] |
Majdoub Haloui, Yanhong Li |
source video |
16 |
| PharmaSUG |
2021 |
Easing the Process of Creating CRF Annotations |
Samadi Karunasundera, Jun Wang |
source |
7 |
| PharmaSUG |
2021 |
First Time Creating a Submission Package? Don-t Worry, We Got You Covered! |
Lyma Faroz |
source |
10 |
| PHUSE EU |
2020 |
Data Integrity & Standards in the Clinical Data Pipeline [presentation] |
Mark Wheeldon, Raj Indupuri |
source video |
30 |
| PHUSE EU |
2020 |
Digital Data Flow - A Solution for Study Start-up and Amendments [presentation] |
Palanipandiyan Chokkalingam, Srinivasan Mahalingam |
source video |
22 |
| PHUSE EU |
2020 |
Don't UnderMine the Value of Your CRF - with Perl Regular Expressions [presentation] |
John McDade |
source video |
22 |
| PHUSE EU |
2020 |
Last Mile Problem to Manage Data Transformation for Analysis & Reporting [presentation] |
Deven Babre, Rajaram Venkatesan |
source video |
19 |
| PHUSE US |
2020 |
Let Us Trace Back to the Beginning from the End |
Madhusudhan Reddy Papasani, Swathi Kotla |
source presentation source |
12 |
| PHUSE EU |
2019 |
Automating the blankcrf.pdf and define.xml with your database build |
John McDade |
source poster source |
6 |
| PharmaSUG |
2019 |
Auto-Annotate Case Report Forms with SAS and SAS XML Mapper |
Yating Gu |
source |
7 |
| PharmaSUG |
2019 |
Validating Hyperlinks in SDTM define.xml Using Python |
Brandon L. Welch, Gregory Weller |
source |
8 |
| PHUSE US |
2019 |
DR3 - A Tool to Create Define-XML (SDTM/ADaM with ARM) [presentation] |
Eric Weising |
source |
7 |
| PHUSE US |
2019 |
The Importance of Work Instructions When Creating Reviewer's Guides |
Jennifer McGrogran |
source poster source |
8 |
| PHUSE US |
2019 |
The Last Time? Efficiently Scheduling the Pieces of Your Submission Deliverables |
Charity Quick, Emily Canosa |
source poster source |
5 |
| PHUSE US |
2019 |
ValueListDefs, MethodDefs and WhereClauses: How to Define Data Traceability in a Metadata Repository |
Judith Goud |
source presentation source |
11 |
| PHUSE EU |
2018 |
Automating SDTM - Get it Prepared with Your Voice |
Akhil Vijayan, Anoop Ambika |
source presentation source |
8 |
| PHUSE EU |
2018 |
Guideline for Submission-ready aCRF |
Christina Paul, Eva Bervar |
source poster source |
5 |
| PHUSE EU |
2018 |
Post-processing PDFs with Ghostscript |
Jonathan North |
source presentation source |
8 |
| PHUSE EU |
2018 |
Stop Copying CDISC Standards |
Craig Parry |
source poster source |
21 |
| PHUSE EU |
2018 |
The "CDISC Stupidario" (the CDISC Nonsense) |
Angelo Pinazzi |
source poster source |
11 |
| PHUSE EU |
2018 |
ValueListDefs, MethodDefs and WhereClauses: How to Define Data Traceability in a Metadata Repository |
Judith Goud |
source presentation source |
11 |
| PharmaSUG |
2018 |
Automatically Configure SDTM Specifications Using SAS and VBA |
Xingxing Wu |
source |
15 |
| PharmaSUG |
2017 |
Leveraging Study Data Reviewer-s Guide (SDRG) in Building FDA-s Confidence in Sponsor-s Submitted Datasets |
Xiangchen (Bob) Cui, Min Chen, Letan (Cleo) Lin |
source |
10 |
| PharmaSUG |
2017 |
Takeaways from Integrating Studies Conducted by Bristol-Myers Squibb (BMS) and ONO |
Yan Wang |
source |
2 |
| PHUSE EU |
2016 |
Fast Track to Define-XML v2.0 - SDTM and ADaM |
Jörn Bilow |
source presentation source |
4 |
| PharmaSUG |
2016 |
Don-t Agonize, Organize: Maximizing efficiency and effectiveness of SAS Programming in Clinical Trials projects, by using Project Management Organizing Methodologies |
Shefalica Chand |
source |
8 |
| PHUSE EU |
2015 |
Automating Production of the blankcrf.pdf in a CRO Environment |
Jonathan North |
source presentation source |
10 |
| PHUSE EU |
2015 |
Developing annotated CRF: SAS, Excel and patience as your friends |
Ilias Pyrnokokis |
source presentation source |
8 |
| PharmaSUG CN |
2015 |
Generating Define.xml Using SAS By Element-by-Element And Domain-by-Domian Mechanism |
Lina Qin |
|
12 |
| PharmaSUG CN |
2015 |
SDTM Electronic Submissions to FDA: Guidelines and Best Practices |
Christina Chang, Kyle Chang |
|
6 |
| PharmaSUG |
2015 |
A Unique Way to Annotate Case Report Forms (CRFs) in PDF, Using Forms Data Format (FDF) Techniques |
Boxun Zhang, Tyler Kelly |
source |
6 |
| PharmaSUG |
2015 |
Process and Programming Challenges in Producing Define.xml |
Mike Molter |
source |
13 |
| PharmaSUG |
2015 |
SDTM Annotations: Automation by implementing a standard process |
Geo Joy, Andre Couturier |
source |
11 |
| PHUSE EU |
2014 |
A Day in the Life of a Data Sharing Specialist [presentation] |
Kelly Mewes |
source |
29 |
| PHUSE EU |
2014 |
A New Era: Open Access to Clinical Trial Data [presentation] |
Guillaume Breton |
source |
21 |
| PHUSE EU |
2014 |
Discover Define-XML |
Mark Wheeldon, Kevin Burges |
source presentation source |
12 |
| PHUSE EU |
2014 |
Looking for SDTM Migration Specialist |
Angelo Tinazzi |
source presentation source |
12 |
| PharmaSUG |
2014 |
Challenges of Processing Questionnaire Data from Collection to SDTM to ADaM and Solutions Using SAS |
Karin LaPann, Terek J. Peterson |
source |
20 |
| SGF |
2014 |
Challenges of Processing Questionnaire Data from Collection to SDTM to ADaM and Solutions Using SAS |
Karin LaPann, Terek J. Peterson |
source |
19 |
| PHUSE EU |
2013 |
Define-XML v2 - What's New |
Lex Jansen |
source presentation source |
15 |
| SGF |
2013 |
A Practical Approach to Creating Define.XML by Using SDTM Specifications and Excel functions |
Amos Shu |
source pdf |
7 |
| PHUSE EU |
2012 |
SAS Clinical Standards Toolkit: define.xml and Value Level Metadata |
Gene Lightfoot |
source presentation source |
27 |
| PHUSE EU |
2012 |
Validation to define.xml |
Sam Tomioka, Steven Huang |
source poster source |
8 |
| PharmaSUG |
2012 |
Using the SAS Clinical Standards Toolkit 1.4 for define.xml creation |
Lex Jansen |
source |
30 |
| PHUSE EU |
2011 |
Ensuring Compliant and Consistent Data Mappings for SDTM-based Studies - an ICON Approach |
Jennie McGuirk, Steven Thacker |
source presentation source |
16 |
| PHUSE EU |
2011 |
Study Composer: a CRF design tool enabling the re-use of CDISC define.xml metadata |
Philippe Verplancke |
source presentation source |
5 |
| PharmaSUG |
2011 |
A Regular Language: The Annotated Case Report Form |
Ryan Wilkins, Joel Campbell |
source |
9 |
| PharmaSUG |
2011 |
Using the SAS Clinical Standards Toolkit for define.xml creation |
Lex Jansen |
source |
20 |
| PHUSE EU |
2010 |
Define.xml - Tips and Techniques for Creating CRT-DDS |
Julie A. Maddox, Mark Lambrecht |
source presentation source |
10 |
| PHUSE EU |
2010 |
New CDISC migration strategies and tools: determining the best approach and employing automated data mapping [presentation] |
Michael Weitz, Lauren Spiess |
source |
29 |
| PharmaSUG |
2010 |
Accessing and using the metadata from the define.xml |
Lex Jansen |
|
22 |
| SGF |
2010 |
Understanding the define.xml File and Converting It to a Relational Database |
Lex Jansen |
source |
20 |
| PHUSE EU |
2009 |
Experiences and lessons learned from a first SDTM submission project |
Paul Vervuren, Bas van Bakel |
source presentation source |
12 |
| PHUSE EU |
2009 |
From raw data to submission: A metadata-driven, repository-based process of data conversion to CDISC |
Dimitri Kutsenko |
source presentation source |
7 |
| PHUSE EU |
2009 |
Using SAS Macros to simplify preparation and validation of SDTM data, Annotated CRFs and Define.xml in a metadata driven environment |
Niels Both |
source presentation source |
10 |
| PharmaSUG |
2009 |
Converting the define.xml to a Relational Database to Enable Printing and Validation |
Lex Jansen |
|
18 |
| PharmaSUG |
2009 |
Understanding the define.xml and converting it to a relational database |
Lex Jansen |
|
17 |
| SGF |
2009 |
A SAS Programmer's Guide to Generating Define.xml |
Michael J. Molter |
source |
24 |
| PHUSE EU |
2008 |
Using the SAS XML Mapper and ODS to create a PDF representation of the define.xml |
Lex Jansen |
source |
21 |
| NESUG |
2008 |
Using the SAS XML Mapper and ODS PDF to create a PDF representation of the define.xml (that can be printed) |
Lex Jansen |
presentation |
20 |
| PharmaSUG |
2008 |
A SAS based solution for define.xml |
Monika Kawohl |
|
18 |
| PharmaSUG |
2008 |
Cost-Effective Solution to Automating the Creation of CDISC define.xml: Using SAS Data _Null_ with Relational Data Model via SAS/AF Application |
Annie S. Guo |
|
12 |
| PharmaSUG |
2008 |
Using the SAS XML Mapper and ODS PDF to create a PDF representation of the define.xml (that can be printed) |
Lex Jansen |
|
20 |
| PHUSE EU |
2007 |
A SAS based solution for define.xml |
Monika Kawohl |
source |
18 |
| PHUSE EU |
2005 |
ODM & define.xml |
David Iberson-Hurst |
source |
58 |
| PharmaSUG |
2004 |
Using SAS to Speed up Annotating Case Report Forms in PDF Format |
Dirk Spruck |
|
7 |
| PharmaSUG |
2003 |
10 Things Every Programmer Should Know About Electronic Submissions |
Greg Silva |
|
4 |
| PharmaSUG |
2003 |
Clinical Data Standards - An eSubmissions Perspective |
Shy Kumar |
|
6 |
| PharmaSUG |
2003 |
Using RTF, EPS and PDFMARK to Automate the Creation of Your DEFINE.PDF Document for Electronic Submissions |
Dirk Spruck, Aventis Behring |
|
6 |
| PharmaSUG |
2001 |
ESUB11, an Application to Automate the Production of Item 11 For NDA Electronic Submissions |
Margaret Hung |
|
8 |
| SUGI |
1999 |
Annotated Case Report Form Automation System |
Anthony M. Cavaliere, Shi-Tao Yeh |
source |
5 |