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annotated crf

69 papers and 12 presentations; 78 titles.

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Conference × Year × Title × Authors Extras Pages
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

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