| WUSS |
2026 |
A Flexible Metadata-Driven and Modular Approach to SDTM Automation [presentation] |
Ruili Shi,
Jiaying Zhang,
Charles Chen |
source |
15 |
| WUSS |
2026 |
From Raw to Compliant: Applying Domain-Specific SAS Macros for Data Cut-Off in Clinical Trials |
Ballari Sen |
source |
26 |
| PharmaSUG CN |
2026 |
ADICE: A Proposed ADaM Dataset Structure for Intercurrent Events in the Estimand Framework |
Lijie Zhu |
source |
11 |
| PharmaSUG CN |
2026 |
AI-Native Real-Time SDTM Mapping and Exploration Agent |
Hao Chen,
Xuejie Zhou,
Haomin Yang,
Qianwang Wang |
source |
13 |
| PharmaSUG CN |
2026 |
Modernizing the Vaccine TAUG: An End-to-End, Output-Driven Framework for Reactogenicity, Immunogenicity, Efficacy, and Reviewer-Ready Submissions |
Lin Chen,
Jialiang Liu |
source |
18 |
| PharmaSUG |
2026 |
ADaM Pet Peeves Part 2: More Things Programmers Do That Make Us Crazy |
Sandra Minjoe,
Nancy Brucken,
Alyssa Wittle,
Nate Freimark,
Richann J. Watson,
Paul K. Slagle,
Tatiana Sotingco |
source |
15 |
| PharmaSUG |
2026 |
AI-Augmented SDTM Review: A Practical Framework Enhanced by a Structured Prompt Library |
Vihar Patel |
source |
10 |
| PharmaSUG |
2026 |
AI-Driven Intelligent Platforms for ADaM Specification and Code: Empowering Clinical Data Analysis |
Tingting Zeng,
Jia He,
Yaohui Zhu,
Shuang Gao,
Jinling Li,
Nana Yang |
source |
11 |
| PharmaSUG |
2026 |
AI-First Leadership in Biometrics: Redefining Strategy, Teams and Execution in the Agentic AI Era |
Kevin Lee |
source |
7 |
| PharmaSUG |
2026 |
Bridging the Gap: Table-Driven SAS Programming as a Pathway to AI in Clinical Trials Statistical Programming |
James Sun,
Vijaya Nadella,
Daniel Qi |
source |
15 |
| PharmaSUG |
2026 |
Closing the Loop: Validating AI-Generated SDTM Mappings using CDISC CORE and Synthetic Data |
Pietro Belligoli,
Constantin Weberpals,
Yarhy Flores Lopez |
source |
7 |
| PharmaSUG |
2026 |
Following Your Footsteps: Maintaining Traceability in ADaM Datasets [presentation] |
Nancy Brucken,
Karl Miller |
source |
59 |
| PharmaSUG |
2026 |
Friction to Flow: LLM-Based Automation of Clinical Data Workflows |
Pankaj Attri,
Matthew J. Becker |
source |
8 |
| PharmaSUG |
2026 |
From Data Flood to Insight: Efficient SDTM Validation for High-Frequency Sources |
Seiko Yamazaki |
source |
6 |
| PharmaSUG |
2026 |
From Manual to Automated": An SAS and R-Based Toolkit for Scalable SDTM Generation |
Hardik Sheth,
Eldho Alias |
source |
8 |
| PharmaSUG |
2026 |
From Specification to SDTM at Speed: Deploying the SDTM Engine in Production |
Lynn Xiuling Zhang,
Jacques Lanoue,
Ulf Nielsen |
source |
11 |
| PharmaSUG |
2026 |
Handling multiple screenings and multiple enrollments in SDTM: CDISC and FDA Guidance |
Laura Williams,
Andrea Gardani |
source |
7 |
| PharmaSUG |
2026 |
Hero-in-the-Loop: A Super Squad Approach to SDTM Creation & Validation |
Julie Ann Hood |
source |
7 |
| PharmaSUG |
2026 |
Navigating Early Career Challenges in PK/ADA Statistical Programming |
Diyu Yang,
Sandeep Meesala |
source |
11 |
| PharmaSUG |
2026 |
Practical Lessons in AI-Assisted Metadata Conversion: From Database Specs to EDC and SDTM - Successes, Pitfalls, and Practical Implementation |
Jianlin Li,
Andy Shen |
source |
11 |
| PharmaSUG |
2026 |
The Next Frontier of Statistical Programming: Vibe Coding with AI Coding Agents into SAS, R & Python |
Kevin Lee,
Nathan Lee |
source |
7 |
| PharmaSUG |
2026 |
Virtual Data, Real Standards: Leveraging Data Simulation for Smarter Clinical Trials |
Sangeeta Shabadi,
Nitesh Patil,
Jonathan Henshaw |
source |
16 |
| PHUSE US |
2026 |
Automating SDTM Compliance: A Web-Based SDTM Quality Control Tool Enhancing Clinical Trial Data Integrity |
Indraneel Narisetty,
Gopal Reddy Palvatla |
source
poster source |
11 |
| PHUSE US |
2026 |
Building High-Quality SDTM from Real-World Data: Lessons and Solutions |
Peishan(Jenny) Han,
Lixiao Chen |
source
presentation source |
4 |
| PHUSE US |
2026 |
Case Study: Leveraging CDISC CORE for Proactive SDTM Compliance and Submission Readiness |
Shivani Gupta |
source
presentation source |
6 |
| PHUSE US |
2026 |
CDISC 360i Demo: Automating from Study Design to Submission |
Darren Moreland |
source
presentation source |
6 |
| PHUSE US |
2026 |
CDISC 360i: From Vision to Implementation - Lessons Learned and the Road Ahead [presentation] |
Peter Van Reusel |
source |
23 |
| PHUSE US |
2026 |
Electronic Clinical Data Submissions Across Global Regulatory Authorities |
Sampath Madanu |
source
presentation source |
12 |
| PHUSE US |
2026 |
Enhancing Clinical Trial Dataset Mapping with AI/ML Techniques: An Approach for CDISC Variable Prediction |
Parvee Kumar |
source
presentation source |
7 |
| PHUSE US |
2026 |
From Black Box to Glass Box: A Context-Aware Approach to SDTM Mapping Automation with Interactive Visual Validation |
Rostislav Markov,
Jacques Lanoue |
source
presentation source |
12 |
| PHUSE US |
2026 |
Incorporating Digital Health Technology (DHT) Data in SDTM - Challenges and Examples |
Swarupa Sudini,
Sandra VanPelt Nguyen |
source
poster source |
7 |
| PHUSE US |
2026 |
Mapping Minimal Residual Disease (MRD) Biomarker Data in Hematologic Malignancies: Clinical Significance and Data Standards in SDTM and ADaM |
Jyothi Nelakurthi |
source
presentation source |
8 |
| PHUSE US |
2026 |
Multi-Standard Submission - Process, Learnings and Recommendations for Best Practice |
Mukesh Garg |
source
presentation source |
8 |
| PHUSE US |
2026 |
Open Source Pavilion: Metadata-driven Automation Interactive [presentation] |
Orla Doyle,
Rammprasad Ganapathy |
source |
28 |
| PHUSE US |
2026 |
Optimising Trial Design Dataset Creation To Minimise P21 Compliance Issues |
Rama Kudaravalli |
source
presentation source |
6 |
| PHUSE US |
2026 |
Revolutionising Clinical Data Transformation: Harnessing GenAI and Open Source for Automated SDTM Conversion |
Hao (Harry) Chen,
Jian Hua Hang |
source
presentation source |
6 |
| PHUSE US |
2026 |
Rule-Based Auto-SDTM Mapping Software in Python, Which Automatically Generates Executable SAS or R Programs |
Carrie Zhang,
Bill Zhang |
source
presentation source |
9 |
| PHUSE US |
2026 |
SDTM Automation: Implementation, Rollout and Lessons Learnt |
Bruce Chambers,
Minda Quiroz |
source
presentation source |
6 |
| PHUSE US |
2026 |
SDTM Navigator: An Agent-Based LLM Framework for Automated Specification and Programming |
Benzi Alex Mathew |
source
presentation source |
3 |
| PHUSE US |
2026 |
SpecToSAS: AI-Powered SAS Code Generation from Study Specs |
Gargee Vaidya,
Lluis Gimenez |
source
presentation source |
12 |
| PHUSE APAC |
2026 |
Batch Execution of CDISC SDTM/ADaM Programs with R |
Batch Execution,
Denny Sebastian,
Mohin K Mohanan |
source
presentation source |
8 |
| PHUSE APAC |
2026 |
CDISC 360i In Action – Demonstrating the Shift to Fully Digital Standards [presentation] |
Darren Moreland,
Julie Smiley,
Bhavin Busa,
Peter Van Reusel |
source |
11 |
| PHUSE APAC |
2026 |
CDISC 360i – Lessons Learned and Road Ahead [presentation] |
Peter Van Reusel |
source |
26 |
| PHUSE APAC |
2026 |
Creating a clinical trial data package for Regulatory submission |
Pradip Sivaramakrishnan,
Anbarasan Durairajan |
source
poster source |
11 |
| PHUSE APAC |
2026 |
Elevating transparency in data standardization Applying XAI in SDTM, ADaM, and TLF Generation |
Shakila Jagadeesan |
source
presentation source |
10 |
| PHUSE APAC |
2026 |
Enhancing Clinical Data Standardization Through Intelligent Mapping of eCRF Forms and Items to SDTM |
Saransh Khandelwal,
Kedar Deshpande |
source
presentation source |
9 |
| PHUSE APAC |
2026 |
Evolving with SDTM-IG v3.4: What Clinical Data Professionals Need to Know |
Prashanth Jatothu,
Nagaraju Salugu |
source
presentation source |
6 |
| PHUSE EU |
2025 |
Automated QC Framework for Reliable ADNCA Dataset Generation with {admiral} |
Valentin Legras,
Lucy Aspridis |
source
presentation source |
4 |
| PHUSE EU |
2025 |
Efficient Conversion of SDTM/ADaM Specifications from Excel to Define-XML v2.1 Using Pinnacle 21 Community |
Hiromi Okada,
Seiko Yamazaki |
source
presentation source |
15 |
| PHUSE EU |
2025 |
From SDTM to a Graph-Based, Multi-Purpose Interface for Data |
Eva Kelty,
Catharina Dahlbo |
source
presentation source |
4 |
| PHUSE EU |
2025 |
Leveraging AI for Seamless SAS to R Migration: Challenges and Opportunities |
Milena Kraus,
Corrina Stoeckinger |
source
presentation source |
11 |
| PHUSE EU |
2025 |
On the Right Track: Managing Platform Modular Studies with a Central Metadata Switchboard |
Dubravka Georgijevic,
Carla Santillán |
source
presentation source |
7 |
| PHUSE EU |
2025 |
Robust Programming Strategies for Exposure to ADaM Datasets |
Susann Grill |
source
poster source |
13 |
| PHUSE EU |
2025 |
The Chicken, the Egg and the ADaM: Cracking the PRE-ADSL vs ADSL Sequence |
Carla Santillán,
Dubravka Georgijevic |
source
presentation source |
8 |
| PHUSE EU |
2025 |
The Show Must Go On: Best Practices for Submitting SDTM Data for Ongoing Studies |
Kristin Kelly |
source
presentation source |
8 |
| PHUSE EU |
2025 |
Turning Data into Deliverables: Automating Biometrics from Metadata to TFLs |
Inderjeet Arora |
source
presentation source |
9 |
| PHUSE EU |
2025 |
Untangling the Dependencies Web |
Rhys McCrosson |
source
presentation source |
12 |
| SESUG |
2025 |
Ensure complete raw data to SDTM mapping: a SAS macro approach for quality control |
Cally Davidson,
Eric Howard |
|
8 |
| SESUG |
2025 |
Obtaining Metadata Information on Data Transfers for Dataset Profiling |
Amy Zhang |
|
7 |
| SESUG |
2025 |
Title: Optimizing Clinical Research Efficiency through SDTM Dataset Splitting Using SAS: Insights from New SDTM Programmers |
Tiffany Bainter,
Maddie Hays |
|
5 |
| PharmaSUG |
2025 |
ADaM Pet Peeves: Things Programmers Do That Make Us Crazy |
Sandra Minjoe,
Nancy Brucken |
source |
13 |
| PharmaSUG |
2025 |
Checking Outside the Box: A Framework for Submission Success |
Julie Ann Hood,
Seiko Yamazaki |
source |
13 |
| PharmaSUG |
2025 |
Checking SDTM Datasets from Biostatistical Perspective |
Inka Leprince,
Elizabeth Li |
source |
14 |
| PharmaSUG |
2025 |
Getting under the "umbrella" of Specimen-based Findings Domains! |
Soumya Rajesh,
Kapila Patel |
source |
11 |
| PharmaSUG |
2025 |
Identification of Domains Containing Screen Failure Participants in SDTMs and ADaMs for Reviewer-s Guides |
Sumanjali Mangalarapu |
source |
5 |
| PharmaSUG |
2025 |
Integration Contemplation: Considerations for a Successful ISS/ISE from Planning to Execution |
Jennifer McGrogan,
Mario Widel |
source |
8 |
| PharmaSUG |
2025 |
Macro to Compare ADaM Spec Derivations Against Available SDTM Data |
Ingrid Shu,
Kexin Guan,
Jeff Xia |
source |
9 |
| PharmaSUG |
2025 |
Roadmap to Efficacy Analysis for Early Phase Oncology studies |
Dhruv Bansal,
Christiana Hawn,
Chris Kelly |
source |
23 |
| PharmaSUG |
2025 |
The Many Use Cases of Standardized Data and Metadata |
Sanjiv Ramalingam |
source |
4 |
| PharmaSUG |
2025 |
The Show Must Go On: Best Practices for Submitting SDTM Data for Ongoing Studies |
Kristin Kelly |
source |
9 |
| PharmaSUG |
2025 |
Updating Define-XML packages: Tips and A Comprehensive Checklist |
Qiong Wei,
Ji Qi,
Lixin Gao |
source |
10 |
| PharmaSUG |
2025 |
When PROC SORT Isn-t Enough: Implementing Horizontal Sorting in SAS |
Krutika Parvatikar,
Jeff Xia |
source |
5 |
| PharmaSUG |
2025 |
Which ADaM Data Structure Is Most Appropriate? Gray Areas in BDS and OCCDS. |
Veronica Gonzalez |
source |
15 |
| PharmaSUG |
2025 |
{sdtm.oak} V0.1 on CRAN, sponsored by CDISC COSA, part of Pharmaverse, is an EDC and Data Standard agnostic solution for developing SDTM datasets in R. |
Rammprasad Ganapathy |
source |
5 |
| PHUSE US |
2025 |
Accelerating Data Integration: Utilizing Python Scripts and Semantic Search for Variable Mapping in Multiple Studies |
Xiaopeng Li |
source
presentation source |
6 |
| PHUSE US |
2025 |
An Intuitive Way to Derive the Last Known Alive Date in R |
Marckenley Mercie,
Diana Tai |
source
presentation source |
12 |
| PHUSE US |
2025 |
Automating your safety data reconciliation: An approach towards reliable and efficient SAE reconciliation process |
Ritu Dogra |
source
presentation source |
11 |
| PHUSE US |
2025 |
Biomedical Concepts: What Are They and Why Should I Care? |
Stuart Malcolm |
source
presentation source |
7 |
| PHUSE US |
2025 |
Effortless SDTM Upversioning: Leveraging Open-Source R for Efficient Data Standardisation |
Ramya Gangadi |
source
presentation source |
7 |
| PHUSE US |
2025 |
Enable and Automate: A Technical Roadmap Defining CDISC's Path to End-to-End Automation |
Samuel Hume |
source
presentation source |
8 |
| PHUSE US |
2025 |
How Unique is it for the Subject Identifier in a Study To Have Multiple Screenings and Enrolments? |
Anahita Vyas,
Rama Kudaravalli |
source
presentation source |
8 |
| PHUSE US |
2025 |
Innovative Storage of SDTM Mappings as JSON: Boosting Efficiency and Data Consistency |
Rohan Parmar,
Edgar Manukyan |
source
presentation source |
5 |
| PHUSE US |
2025 |
Kraken: A Shiny Application for Visualising SDTM Data in Early-Phase Clinical Trials |
Rutu Patel |
source
presentation source |
12 |
| PHUSE US |
2025 |
Let's Talk Future: Automated Solution for Standard-Compliant Data, Mock Shells and TFL Generation Using Open-Source Platforms with AI |
Inderjeet Arora,
Abhijeet Arora |
source
presentation source |
8 |
| PHUSE US |
2025 |
Natural Language to Code: AI-Powered Automation for CDISC-Compliant Datasets |
Vina Ro |
source
presentation source |
5 |
| PHUSE US |
2025 |
Optimising SDTM and ADaM: Remediation Techniques for Data Accuracy |
Kishore Pothuri |
source
presentation source |
10 |
| PHUSE US |
2025 |
Standardised and Automated Template for Dose Escalation Decision-Making |
Jasmina Uzunovic,
Aditi Qamra |
source
presentation source |
6 |
| PHUSE US |
2025 |
The Show Must Go On: Best Practices for Submitting SDTM Data for Ongoing Studies |
Kristin Kelly |
source
presentation source |
8 |
| PHUSE US |
2025 |
Using the USDM and Ensuring Governance and Traceability to unlock the potential of Real-World Data sources for regulatory submissions |
Berber Snoeijer |
source
presentation source |
12 |
| PHUSE US |
2025 |
Utility Macro for Ensuring Consistent Updates of CRF Data in SDTM |
Naren Surampalli |
source
presentation source |
8 |
| PHUSE US |
2025 |
What's Up with icSDRG? Navigating Through an Example [poster] |
Srinivas Kovvuri,
Bidhya Basnet |
source |
1 |
| PHUSE US |
2025 |
{sdtm.oak} - SDTM Programming in R |
Rammprasad Ganapathy,
Shiyu Chen |
source
poster source |
5 |
| PHUSE EU |
2024 |
Accelerating Trial Startup: Automated Central Monitoring Visualisations and Safety Package Management |
Carsten Rødseth Barsøe,
Charlotte Bergknut |
source
presentation source |
4 |
| PHUSE EU |
2024 |
Behind the Blind: Enhancing Clinical Data Management with Python |
Niels Schrauwen |
source
presentation source |
5 |
| PHUSE EU |
2024 |
Data Traceability Map with R Shiny |
Alexander Mkrtchyan,
Sevak Kamalyan |
source
presentation source |
8 |
| PHUSE EU |
2024 |
Guidance Beyond the SDTM Implementation Guide |
Kristin Kelly |
source
presentation source |
10 |
| PHUSE EU |
2024 |
Harmonising FDA and PMDA Submission Requirements |
Luca Semeraro |
source
presentation source |
12 |
| PHUSE EU |
2024 |
Harmonization and Interoperability between OMOP CDM and CDISC SDTM |
Dhruba Sikdar |
source
presentation source |
8 |
| PHUSE EU |
2024 |
Leveraging 'Ensemble' Machine Learning Models to Drive Automation of Specification Generation and Data Mapping in Clinical Trial Data Submission |
Venu Mallarapu |
source
presentation source |
10 |
| PHUSE EU |
2024 |
Making SDTM/ADaM CRT Packages Submission Ready |
Phillip Spowart |
source
presentation source |
10 |
| PHUSE EU |
2024 |
OAK Productivity Experiment - How We Made SDTM Programming 5x Faster |
Amy Franklin,
Magdalena Krochmal |
source
presentation source |
5 |
| PHUSE EU |
2024 |
Our Road to Adopting CORE: an Implementation Journey in SDTM Dataset Validation |
Marisa Wyckmans |
source
presentation source |
7 |
| PHUSE EU |
2024 |
Synthesised Real-world Data: JSON and the Argonauts |
Anil Sekhari |
source
presentation source |
10 |
| PHUSE EU |
2024 |
The Challenges of Using Parent Study Data in a Long-Term Extension Study |
Kirsty Wall |
source
presentation source |
9 |
| PHUSE EU |
2024 |
The Significance of Generic Data Transfer Specification for Non-CRF Data in Clinical Trials |
Samaneh Sabiani,
Kristina Zweier |
source
presentation source |
9 |
| PHUSE EU |
2024 |
Working with Omics data - A Statistical Programmers perspective |
Adrian Czaban |
source
presentation source |
10 |
| SESUG |
2024 |
Applying Different Data Cutoff Dates for the Analysis of a Study Milestone |
Guowei Zhao,
Hong Qi |
source |
7 |
| WUSS |
2024 |
Automation of Submission of Programs in Analysis Data Reviewer's Guide for FDA and PMDA Submissions |
Junying Zhang |
source |
14 |
| PharmaSUG CN |
2024 |
A metadata-driven system to generate annotated CRF automatically |
Guojun Liufu,
Jun Wu,
Li Chen,
Zhen Peng,
Fushan Lai,
Hanjia Zheng |
source |
7 |
| PharmaSUG CN |
2024 |
An Automatic SDTM Platform: Create Your SDTM Since Case Report Form is Ready! |
Mingyue Zhu,
Wei Wang,
Mingfeng Zhou |
source |
12 |
| PharmaSUG CN |
2024 |
Automatic ADaM Network Analysis Extracting from Metadata/Define/Log with R Shiny |
Jun Zhai |
source |
10 |
| PharmaSUG CN |
2024 |
CDASH-SDTM Combo Model in SDTM Automation |
Chunpeng CZ Zhao |
source |
11 |
| PharmaSUG CN |
2024 |
Extracting Useful Information from XFDF Format of aCRF Annotations |
Tingting Zhang,
Yuan Sun |
source |
13 |
| PharmaSUG CN |
2024 |
The Imperative Role of Data Cut-Off (DCO) in Clinical Trials: Ensuring Integrity and Precision in Oncology |
Nana Yang,
Chunpeng CZ Zhao |
source |
6 |
| PharmaSUG |
2024 |
A New Approach to Automating the Creation of the Subject Visits (SV) Domain |
Xiangchen (Bob) Cui,
Jessie Wang,
Min Chen |
source |
24 |
| PharmaSUG |
2024 |
A Practical Approach to Automating SDTM Using a Metadata-Driven Method That Leverages CRF Specifications and SDTM Standards |
Xiangchen (Bob) Cui,
Min Chen,
Jessie Wang |
source |
23 |
| PharmaSUG |
2024 |
AutoSDTM Design and Implementation With SAS Macros |
Chengxin Li |
source |
10 |
| PharmaSUG |
2024 |
CDISC Therapeutic Area User Guides and ADaM Standards Guidance |
Karin LaPann |
source |
6 |
| PharmaSUG |
2024 |
Challenges and Considerations When Building e-Submission SDTM Data Packages |
Wei Duan |
source |
8 |
| PharmaSUG |
2024 |
Cultivating Success with Non-standard Investigator-sponsored Trial Data for FDA Submissions |
Jai Deep Mittapalli,
Jinit Mistry,
Venkatesulu Salla |
source |
9 |
| PharmaSUG |
2024 |
Enhanced Spider Plot in Oncology |
Ilya Krivelevich,
Cixin He,
Binbin Zhang-Wiener,
Wenyin Lin |
source |
14 |
| PharmaSUG |
2024 |
Game changer! The new CDISC ADaM domain ADNCA for PK/PD data analysis |
Santosh Ranjan |
source |
7 |
| PharmaSUG |
2024 |
Guidance Beyond the SDTM Implementation Guide |
Kristin Kelly,
Michael Beers |
source |
11 |
| PharmaSUG |
2024 |
Is a Participation-Level ADaM Dataset a Solution for Submitting Integration Data to FDA? |
Sandra Minjoe |
source |
7 |
| PharmaSUG |
2024 |
Protocol Amendments and EDC Updates: Downstream impact on Clinical Trial Data |
Anbu Damodaran,
Ram Gudavalli,
Kumar Bhimavarapu |
source |
11 |
| PharmaSUG |
2024 |
Source Data Quality Issues in PopPK/PD Dataset Programming: a Systematic Approach to Handle Duplicates |
Ibrahim Priyana,
Ellen Winckelmans |
source |
10 |
| PharmaSUG |
2024 |
Unravelling the SDTM Automation Process through the Utilization of SDTM Transformation Template |
Lakshmi Mantha,
Inbasakaran Ramesh |
source |
11 |
| PharmaSUG |
2024 |
Your Guide to Successfully Upversioning CDISC Standards |
David Neubauer,
Kapila Patel,
Toral Patel,
Soumya Rajesh |
source |
19 |
| PHUSE US |
2024 |
A Practical Approach to Automating SDTM Using a Metadata-Driven Method that Leverages eCRF Specifications and SDTM Programming Standards |
Xiangchen (Bob) Cui,
Min Chen |
source
presentation source |
12 |
| PHUSE US |
2024 |
Addressing Challenges in Structuring CDISC SDTM and ADaM Datasets to Report Adverse Events Spanning Two Treatment Periods |
Madhusudhan Reddy Papasani |
source
presentation source |
4 |
| 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 US |
2024 |
Demystifying Submissions to NMPA China [presentation] |
Hiral Raval,
Dyuthi Yellamraju |
source |
19 |
| PHUSE US |
2024 |
Effective Workflow Process: Rapid SDTMs and Compliance Dashboards |
Sunil Kumar Gupta,
Harinarayan Gopichandra |
source
poster source |
5 |
| PHUSE US |
2024 |
Eliminating SDTM Double Programming by Using a Validation Tool and Dummy Data |
Glenn Borgmans,
Tine Seeuws |
source
presentation source |
8 |
| PHUSE US |
2024 |
Guidance Beyond the SDTM Implementation Guide |
Michael Beers,
Blue Bell |
source
presentation source |
10 |
| PHUSE US |
2024 |
Journey of Reactogenicity Data from EDC to SDTM to Analysis Datasets |
Charumathy Sreeraman |
source
presentation source |
10 |
| PHUSE US |
2024 |
Mapping Real-World Data (RWD) to SDTM Samples for External Control Arm or Registry Studies |
Joe Xi,
Kevin Yang |
source
presentation source |
3 |
| PHUSE US |
2024 |
Post-Pandemic Trends in Study Designs |
Charumathy Sreeraman,
Jisha George |
source
presentation source |
7 |
| PHUSE US |
2024 |
Streamlining the Integration of SDTM Datasets from Multiple Studies: A Macro Approach |
Santosh Reddy Lekkala |
source
presentation source |
7 |
| PHUSE US |
2024 |
The Many Use Cases of Standardized Data and Metadata |
Sanjiv Ramalingam |
source
presentation source |
4 |
| PHUSE US |
2024 |
Transformative Strategies in People Leadership and Management for Organisational Success |
Bhanojinaidu Duppada,
Sumanth Goud Bheemagani |
source
presentation source |
8 |
| PHUSE US |
2024 |
Translating Data into Tableau Insights: Bridging the Gap Between Programmers and Medical Physicians |
Agnieszka Bel |
source
presentation source |
7 |
| PHUSE US |
2024 |
Unveiling the Potential of ADNCA via the CDISC ADaM IG: Revolutionising Pharmacokinetic Non-Compartmental Analysis Input Data Standardisation |
Saumilkumar Tripathi |
source
presentation source |
10 |
| PHUSE US |
2024 |
USUBJID Challenges: Representing Multiple Participations for Analysis and Reporting |
Emily Bernstein-Hanlon,
Sirisha Davuluri |
source
presentation source |
9 |
| PHUSE EU |
2023 |
Challenges in Oncology Modular studies: The Fortrea approach |
Francesca Dall'Acqua |
source
presentation source |
7 |
| PHUSE EU |
2023 |
Creating CORE Rules from Biomedical Concepts |
Johannes Ulander |
source
presentation source |
8 |
| PHUSE EU |
2023 |
Enhancing the Quality of Data Harmonisation - a Customisable Tool for Validation of Bespoke SDTM Implementation at the Infectious Diseases Data Observatory (IDDO) [poster] |
Sadie Kelly,
Dick Hung |
source |
1 |
| PHUSE EU |
2023 |
Experiencing the FDA CBER |
Merve Akram,
Angelo Tinazzi |
source
presentation source |
9 |
| PHUSE EU |
2023 |
Handling Multiple Screenings Using the New Domain DC (Demographics for Multiple Participations) at Merck - Implementation of a New Mapping Process [presentation] |
Kristina Zweier |
source |
21 |
| PHUSE EU |
2023 |
Implementation of MedDRA upgrade in SDTM: a SAS-based approach |
Mahmoud Abu Azoum |
source
presentation source |
5 |
| PHUSE EU |
2023 |
MINT+ Automation and Digitization of SDTM specification |
Magdalena Krochmal |
source
presentation source |
5 |
| PHUSE EU |
2023 |
Oak Garden - Metadata-Driven SDTM Automation in R |
Magdalena Krochmal,
Amy Franklin |
source
presentation source |
7 |
| PHUSE EU |
2023 |
Real-Time Safety and Medical Review by Integrating Data Visualisations with an SCE |
Shivoy Pandita,
Santhoshi Madeswaran |
source
presentation source |
8 |
| PHUSE EU |
2023 |
Slicing Codes: A Modular approach to ADaM programming |
Mahendran Venkatachalam |
source
presentation source |
10 |
| PHUSE EU |
2023 |
Standardisation in a fast growing environment; MDR, EDC and other abbreviations |
Louella Schoemacher,
Jasmine Kestemont |
source
presentation source |
6 |
| PHUSE EU |
2023 |
The Curious Case of Observational Studies - A Programmer's Dilemma |
Vikas Shokeen |
source
presentation source |
11 |
| PHUSE EU |
2023 |
Validating Outsourced Programming Tasks by Comparing SAS Datasets Without PROC COMPARE |
Herman Ament |
source
presentation source |
5 |
| SESUG |
2023 |
For Clinical Trials: A Faster and Smoother Approach to Create your SDTM and ADAM Define Specifications for Define.xml with SAS |
Star Nze |
source |
29 |
| PharmaSUG |
2023 |
'TUFF' LOVE: SDTM Pain Points Explained! |
Kristin Kelly,
Michael Beers |
source |
12 |
| PharmaSUG |
2023 |
A Macro Utility for CDISC Datasets Cross Checking |
Chao Su,
Jaime Yan,
Changhong Shi |
source |
9 |
| PharmaSUG |
2023 |
Automating SDTM: A metadata-driven journey. |
Keith Hibbetts |
source |
11 |
| PharmaSUG |
2023 |
Automation of Dataset Programming Based on Dataset Specification |
Liqiang He |
source |
7 |
| PharmaSUG |
2023 |
Automation of the SDSP CBER Appendix for Vaccine Studies |
Nicole Jones,
Pritesh Solanki |
source |
6 |
| PharmaSUG |
2023 |
Can We Do It Better? Real-Time Validation Of Sdtm Mapping Is Superior To Double Programming |
Daniel Rolo,
Bremer Louw |
source |
9 |
| PharmaSUG |
2023 |
Have Meaningful Relationships: An Example of Implementing SDTM Special Purpose Data Set RELREC with a Many-to-Many Relationship |
Kaleigh Ragan,
Richann J. Watson |
source |
11 |
| PharmaSUG |
2023 |
Integrated Trial Design Model Datasets? |
Christine McNichol |
source |
9 |
| PharmaSUG |
2023 |
Leverage and Enhance CDISC TAUGs to Build More Traceability for and Streamline Development of Efficacy ADaM in Oncology Studies |
Xiangchen (Bob) Cui |
source |
29 |
| PharmaSUG |
2023 |
SDTM Variables You Might Forget About |
Nadiia Pukhliar,
Dariia Tsyhanenko,
Iryna Kotenko |
source |
10 |
| PharmaSUG |
2023 |
Sound SDTM, Sound ADaM - Orchestrating SDTM and ADaM Harmonization |
Nancy Brucken,
David Neubauer,
Soumya Rajesh |
source |
8 |
| PharmaSUG |
2023 |
Standardization of Reactogenicity Data into Findings |
Charumathy Sreeraman |
source |
9 |
| PharmaSUG |
2023 |
Traceability: Not just about Data |
Rohit Nagpal,
Kavitha Mullela |
source |
11 |
| PharmaSUG |
2023 |
Working with Biomedical Concepts and SDTM Dataset Specializations for Define-XML using SAS Open CST |
Lex Jansen |
source |
23 |
| PHUSE US |
2023 |
Best Practice for Successful Adoption and Implementation of CDISC Data Standards [presentation] |
Gilbert Hunter,
Martin Johnston |
source
video |
25 |
| PHUSE US |
2023 |
Custom Domains ... the Gaps in Standardized Data |
Michael Beers |
source
presentation source |
8 |
| PHUSE US |
2023 |
Exploring the Possibility of Automating SDTM Domain Subject Visits (SV) |
Limna Salim |
source
presentation source |
8 |
| PHUSE US |
2023 |
Managing Deliverables in Oncology Basket Trials |
Hong Qi,
Mary N. Varughese |
source
presentation source |
6 |
| PHUSE US |
2023 |
SAS Macro for Converting Variable Attributes from XLSX Specifications to SDTM/ADAM SAS data sets |
Jinquan Wu |
source
presentation source |
8 |
| PHUSE US |
2023 |
Up-to-Date with Dates - Imputation Rules in R Compared to SAS |
Monika Ludwinska |
source
presentation source |
10 |
| PHUSE EU |
2022 |
An Approach to Effectively Reproduce TFLs When Performing ADaM Conversion [presentation] |
Amine Khemiri,
Caroline Pelckmans |
source
video |
19 |
| PHUSE EU |
2022 |
Automation of Standard ADaM Variables Through an R Package - GenAdam |
Mahesh Divakaran |
source
presentation source |
8 |
| PHUSE EU |
2022 |
Do It Yourself: Case Report Form (CRF) Annotation |
Caro Sluijter |
source
presentation source |
5 |
| PHUSE EU |
2022 |
How a Clinical Metadata Repository Facilitates Compliance with Industry Standards and Expedites Metadata Storage, Sharing, Analysis and Submission Times |
Gilbert Hunter |
source
presentation source |
2 |
| PHUSE EU |
2022 |
iCDM: Interactive Dashboards that Innovate Centralised Clinical Data Monitoring at Danone Nutricia Research |
Paul Vervuren,
Dennis Menkveld |
source
video
presentation source |
5 |
| PHUSE EU |
2022 |
Overcoming Challenges of Your Integrated Summary ISS/ISE Submissions |
Jenet Cp,
Akhil Vijayan |
source
presentation source |
7 |
| PHUSE EU |
2022 |
Protocol Deviation Programming [presentation] |
Oussama Zineddine,
Caroline Pelckmans |
source
video |
25 |
| PHUSE EU |
2022 |
Release Your Creativity on Your Company Laptop |
Johannes Ulander |
source
presentation source |
10 |
| PHUSE EU |
2022 |
Table of Contents (TOC) - An Application of PowerShell |
Sumit Pratap Pradhan,
Navneet Agnihotri |
source
video
presentation source |
6 |
| PHUSE EU |
2022 |
The Integration Dilemma |
Angelo Tinazzi |
source
video
presentation source |
15 |
| PHUSE EU |
2022 |
Title:Pixel Plots: Identify Missing Data, See High-level Patterns and Break Axis Constraints |
Paul Grimsey |
source
presentation source |
16 |
| PharmaSUG |
2022 |
A SAS Macro to Support the Supplemental Qualifier Section in cSDRG |
Jamuna Purma,
Bindya Bindya Vaswani |
source |
9 |
| PharmaSUG |
2022 |
Above and Beyond Lesion Analysis Dataset (ADTL) |
Raghava Pamulapati |
source |
11 |
| PharmaSUG |
2022 |
ADCM Macro Design and Implementation |
Chengxin Li,
Tingting Tian,
Toshio Kimura |
source |
7 |
| PharmaSUG |
2022 |
Checking Compliance of CDISC SDTM Datasets Utilizing SAS Procedures. |
Ballari Sen |
source |
17 |
| PharmaSUG |
2022 |
Clinical Classifications: Getting to know the new kid on the QRS block! |
Soumya Rajesh,
Michael Wise |
source |
9 |
| PharmaSUG |
2022 |
Following Your Footsteps: Maintaining Traceability in ADaM Datasets |
Nancy Brucken,
Karl Miller |
source |
58 |
| PharmaSUG |
2022 |
Lessons Learned from Using P21 to Create ADaM define.xml with Examples |
Yizhuo Zhong,
Christine S Teng,
Majdoub Haloui |
source |
8 |
| PharmaSUG |
2022 |
Making an ADaM Dataset Analysis-Ready |
Sandra Minjoe |
source |
10 |
| PharmaSUG |
2022 |
Real Time Oncology Review Readiness from Programming Perspective |
Binal Mehta,
Patel Mukesh |
source |
10 |
| PharmaSUG |
2022 |
Subjects Enrolled in Multiple Cohorts within a Study - Challenges and Ideas |
Peng Du,
Hongli Wang |
source |
7 |
| PHUSE US |
2022 |
Collection, Standardization, and Reporting of Adverse Events with Toxicity Changes Using CDISC Standards in Oncology Clinical Trials |
Madhusudhan Reddy Papasani,
Swathi Kotla,
Elisabeth Pyle |
source
video
presentation source |
12 |
| PHUSE US |
2022 |
How Rapid SDTM Data Conversion Enabled Early Insights into Vaccine Safety and Efficacy in COVID-19 Trials [presentation] |
Gilbert Hunter,
Rachael Yates |
source
video |
16 |
| PHUSE US |
2022 |
Metadata-driven Case Report Tabulation for Regulatory Submissions |
Jacques Lanoue,
Rajashekar Thota |
source
presentation source |
8 |
| PHUSE US |
2022 |
Vaccine Trials: The Basics You Need to Know [presentation] |
Prashanthi Selvakumar |
source |
11 |
| PHUSE EU |
2021 |
Advanced Excel Specification for Automatic SDTM Generation |
Aleksandra Gorbunova,
Ilya Mishchenko |
source
video
presentation source |
10 |
| PHUSE EU |
2021 |
Balancing Automation and Flexibility in Programming Processes |
Helen Nicholson,
Punitha Philip |
source
video
presentation source |
5 |
| PHUSE EU |
2021 |
F3: Fitness, FAIR & Filing [presentation] |
Bhupendra Mistry,
Nigel Montgomery |
source
video |
19 |
| PHUSE EU |
2021 |
How to Be Traceable in ADaM |
Angelo Tinazzi |
source
video
presentation source |
9 |
| PHUSE EU |
2021 |
Programming Infrastructure to Automate Process Flow for CSS [presentation] |
Archana Nayak,
Salvatore Saporito |
source
video |
22 |
| PHUSE EU |
2021 |
Real-world Data, CDISC SDTM, HL7 FHIR and the Future of Regulatory Submissions [presentation] |
Jozef Aerts |
source
video |
17 |
| PHUSE EU |
2021 |
Utilising LSAF for Data Management at a Belgian Biotech |
Louella Schoemacher |
source
video
presentation source |
7 |
| PHUSE US |
2021 |
ADaM Generator Tool [presentation] |
Gustav Bernard |
source
video |
45 |
| PHUSE US |
2021 |
Automation of a Web-based Metadata Repository for SAS Datasets with Selenium Technology [presentation] |
Eugene Tsykalov |
source
video |
14 |
| PHUSE US |
2021 |
Get Ready in One Click: Clean SDTM Datasets by Using Library Backend Rules [presentation] |
Annelies Van Zeveren,
Sofie Stynen |
source
video |
49 |
| PHUSE US |
2021 |
Pinnacle 21: Improving the Data Fitness Score for eSubmission |
Renu Motwani |
source
video
presentation source |
9 |
| PHUSE US |
2021 |
The Encoding Dilemma |
Angelo Tinazzi |
source
video
presentation source |
10 |
| PHUSE US |
2021 |
VALSPEC Utility to Validate CDISC Specifications [presentation] |
Aman Bahl,
Hrideep Antony |
source
video |
12 |
| PharmaSUG |
2021 |
A Lead Programmer-s Guide to a Successful Submission |
Pranav Soanker,
Santosh Shivakavi |
source |
8 |
| PharmaSUG |
2021 |
A Unique Way to Identify the Errors in SDTM Annotations Using SAS |
Xingxing Wu,
Bala Dhungana |
source |
9 |
| PharmaSUG |
2021 |
ADaM Implementation Guide for Medical Devices |
Julia Yang,
Silvia Faini,
Karin LaPann |
source |
11 |
| PharmaSUG |
2021 |
Archival Tool: Automation using PowerShell |
Sumit Pratap Pradhan |
source |
9 |
| PharmaSUG |
2021 |
Generating FDA-ready Submission Datasets directly from EHRs |
Jozef Aerts |
source |
9 |
| PharmaSUG |
2021 |
Generating Synthetic CDISC Clinical Trial Data. |
Jose C. Lacal |
source |
14 |
| PharmaSUG |
2021 |
Multiple Successful Submissions of Medical Device Clinical Trial Data in the US and China using CDISC |
Phil Hall,
Tikiri B. Karunasundera,
Subendra Maharjan,
Vijaya Vegesna |
source |
10 |
| PharmaSUG |
2021 |
PROC FUTURE PROOF v1.1 - Linked Data |
Amy Gillespie,
Susan Kramlik,
Suhas R. Sanjee,
Jindřich Mynarz,
Danfeng Fu |
source |
12 |
| PharmaSUG |
2021 |
Types of Devices in Therapeutic Area User Guides |
Carey G. Smoak |
source |
7 |
| PharmaSUG |
2021 |
Where-s Waldo? An SDTM Crawler |
Derek P. Morgan |
source |
9 |
| PHUSE EU |
2020 |
Advancing SDTM Annotation Through Automation [presentation] |
Anja Kreis,
Wolfgang Rohnert |
source
video |
20 |
| PHUSE EU |
2020 |
Clean Data One Click Away: Using Backend Library Rules to Clean on SDTM Datasets |
Annelies Van Zeveren,
Glenn Borgmans |
source
video
presentation source |
46 |
| PHUSE EU |
2020 |
Don't UnderMine the Value of Your CRF - with Perl Regular Expressions [presentation] |
John McDade |
source
video |
22 |
| PHUSE EU |
2020 |
Let CDISC Be |
Roxane Debrus,
Silvia Faini |
source
video
presentation source |
8 |
| PHUSE EU |
2020 |
Let food be thy medicine and medicine be thy food |
Fatima Kassim |
source
video
presentation source |
8 |
| PHUSE EU |
2020 |
Pooling lab data to support FDA submission: keep it clear and simple |
Joske van Schijndel |
source
video |
5 |
| PHUSE EU |
2020 |
The Good? The Bad? Or the Ugly? CDISC eSubmission Packages in Practice [presentation] |
Artur Krupa |
source
video |
26 |
| PHUSE EU |
2020 |
The TransCelerate Hackathon: Accelerating Development [presentation] |
Johannes Ulander |
source
video |
26 |
| SESUG |
2020 |
Check the aCRF through Programming |
Hengwei Liu,
Daiichi Sankyo |
source |
12 |
| PharmaSUG |
2020 |
A Novel Solution for Converting Case Report Form Data to SDTM using Configurable Transformations |
Sara Shoemaker,
Matthew Martin,
Robert Kleemann,
David Costanzo,
Tobin Stelling |
source |
12 |
| PharmaSUG |
2020 |
An Effective Management Approach for a First-Time Study Lead |
Himanshu Patel,
Jeff Xia |
source |
10 |
| PharmaSUG |
2020 |
CDISC Standards for Medical Devices: Historical Perspective and Current Status |
Carey G. Smoak |
source |
8 |
| PharmaSUG |
2020 |
Data Review: What's Not Included in Pinnacle 21? |
Jinit Mistry,
Lyma Faroz,
Hao Meng |
source |
7 |
| PharmaSUG |
2020 |
Data Transformation: Best Practices for When to Transform Your Data |
Janet E. Stuelpner,
Olivier Bouchard,
Mira Shapiro |
source |
4 |
| PharmaSUG |
2020 |
Ensuring Consistency Across CDISC Dataset Programming Processes |
Jennifer K. Fulton |
source |
10 |
| PharmaSUG |
2020 |
Generating ADaM compliant ADSL Dataset by Using R |
Vipin Kumpawat,
Lalitkumar Bansal |
source |
9 |
| PharmaSUG |
2020 |
Improving the Quality of Define.xml: A Comprehensive Checklist Before Submission |
Ji Qi,
Yan Li,
Lixin Gao |
source |
8 |
| PharmaSUG |
2020 |
Is Your Dataset Analysis-Ready? |
Kapila Patel,
Nancy Brucken |
source |
10 |
| PharmaSUG |
2020 |
MKADRGM: A Macro to Transform Drug-Level SDTM Data into Traceable, Regimen-Level ADaM Data Sets |
Sara McCallum |
source |
34 |
| PharmaSUG |
2020 |
Overcoming Pitfalls of DS: Shackling the 'Elephant in the room' |
Soumya Rajesh,
Michael Wise |
source |
9 |
| PharmaSUG |
2020 |
PROC Future Proof; |
Amy Gillespie,
Susan Kramlik,
Suhas R. Sanjee |
source |
8 |
| PharmaSUG |
2020 |
Simplifying PGx SDTM Domains for Molecular biology of Disease data (MBIO). |
Sowmya Srinivasa Mukundan,
Charumathy Sreeraman |
source |
6 |
| PharmaSUG |
2020 |
Successful US Submission of Medical Device Clinical Trial using CDISC |
Phil Hall |
source |
6 |
| PharmaSUG |
2020 |
Untangling the Subject Elements Domain |
Christine McNichol |
source |
8 |
| PharmaSUG |
2020 |
Updates in SDTM IG V3.3: What Belongs Where - Practical Examples |
Lucas Du,
William Paget,
Lingyun Chen,
Todd Case |
source |
8 |
| PHUSE US |
2020 |
Automating Module 5 Packaging with Customizable Metadata |
Dhananjay Chhatre,
Kevin Miller |
source
presentation source |
6 |
| PHUSE US |
2020 |
Case Study: Integrated SDTM to Integrated ADaM to TLFs |
Kishore Pothuri |
source
presentation source |
6 |
| PHUSE US |
2020 |
Complexities in Adhering to Data Standards for ISS NDA Submissions |
Vidya Muthukumar |
source
presentation source |
3 |
| PHUSE US |
2020 |
Confusing Data Validation Rules Explained, Part 2 |
Michael Beers,
Blue Bell |
source |
6 |
| PHUSE US |
2020 |
Data Exchange in Clinical Trial - Programming Perspective |
Chao Wang |
source
presentation source |
5 |
| PHUSE US |
2020 |
Data Standards Used for Electronic Submission of Real-World Evidence in New Drug Application (NDA) |
Nicole Thorne,
Kathy Wu |
source
presentation source |
10 |
| PHUSE US |
2020 |
Efficacy ADaMs in Oncology - Step by Step (Dataset by Dataset) |
Ilya Krivelevich,
Ran Xie |
source
presentation source |
8 |
| PHUSE US |
2020 |
Feature of SDTM Mapping and Conversion Using NLP |
Eric Weising,
Shiva Katepalli |
source
presentation source |
3 |
| PHUSE US |
2020 |
Handling Duplicate Records in SDTM for Effective Resolution and Explanation in Data Submission |
Varun Debbeti |
source
presentation source |
8 |
| PHUSE US |
2020 |
How to reduce programming time for ADaM Creation? - Presenting STAG, a Tool Based Approach |
Diganta Bose |
source
presentation source |
16 |
| PHUSE US |
2020 |
Let Us Trace Back to the Beginning from the End |
Madhusudhan Reddy Papasani,
Swathi Kotla |
source
presentation source |
12 |
| PHUSE US |
2020 |
The JumpStart Traceability Assessment |
Tejas Patel,
Sarah Ferkov |
source |
10 |
| PHUSE US |
2020 |
Untangling the Subject Elements Domain |
Christine McNichol |
source
presentation source |
7 |
| PHUSE EU |
2019 |
ADSL - Friend or Foe? |
Jørgen Mangor Iversen |
source
presentation source |
8 |
| PHUSE EU |
2019 |
An Introduction to Python: The SAS Programmer's Guide |
Bradley Harris |
source
presentation source |
8 |
| PHUSE EU |
2019 |
CDISC 360: Continuing the Journey Towards End-to-End Automation |
Peter Van Reusel |
source
presentation source |
3 |
| PHUSE EU |
2019 |
Deconstructing SDTM - Starting Again |
Johannes Ulander |
source
presentation source |
5 |
| PHUSE EU |
2019 |
Early experiences using SDTM to organize clinical data collected using a physical activity tracker |
Martin Gram,
Gianluca Mortari |
source
presentation source |
13 |
| PHUSE EU |
2019 |
End-to-end SDTM Automation: A Metadata-centric Approach (winner) |
Roman Radelicki |
source
presentation source |
12 |
| PHUSE EU |
2019 |
Fake it Till You Make it with Global SDTM Laboratory Submissions [presentation] |
Éanna Kiely |
source |
31 |
| PHUSE EU |
2019 |
Formedix On: Advanced Metadata Management and Data Conversion [presentation] |
Kevin Burges |
source |
47 |
| PHUSE EU |
2019 |
Harmonising SDTM at the Source: Two Years Later |
Helen Scanlon,
Sue Huxtable |
source
presentation source |
11 |
| PHUSE EU |
2019 |
How Can We Ensure Our Study Data is F.A.I.R. (Findable, Accessible, Interoperable and Reusable)? |
Alana Harris |
source
presentation source |
4 |
| PHUSE EU |
2019 |
Making data mapping process easier and smarter with SAS and R |
Andrii Artemchuk |
source
presentation source |
10 |
| PHUSE EU |
2019 |
Mapping Raw Data to SDTM Define Using the SAS Clinical Standards Toolkit |
Andrew Bullivant |
source
presentation source |
7 |
| PHUSE EU |
2019 |
Poster PP25 An Algorithm for Prioritizing Time Constrained Clinical Trial Activities |
Andy Richardson |
source
poster source |
7 |
| PHUSE EU |
2019 |
SDTM Validation Tool |
Anamaria Calai |
source
presentation source |
12 |
| PHUSE EU |
2019 |
The Trials and Tribulations of Automated SDTM Delivery |
Edward R. Jones |
source
presentation source |
5 |
| PHUSE EU |
2019 |
TS does not mean T(o) S(uffer) - A hands-on guideline for a better understanding of the TS domain |
Kristina Zweier |
source
presentation source |
14 |
| PHUSE EU |
2019 |
Work Less - Do More: An Automated Approach to Define-XML Validation |
Kai Wanke |
source
presentation source |
8 |
| PharmaSUG |
2019 |
An Automated, Metadata Approach to Electronic Dataset Submissions |
Janette Garner |
source |
8 |
| PharmaSUG |
2019 |
Auto-Annotate Case Report Forms with SAS and SAS XML Mapper |
Yating Gu |
source |
7 |
| PharmaSUG |
2019 |
Automate the Process to Ensure the Compliance with FDA Business Rules in SDTM Programming for FDA Submission |
Xiangchen (Bob) Cui,
Hao Guan,
Min Chen,
Letan (Cleo) Lin |
source |
16 |
| PharmaSUG |
2019 |
Best Practices for ISS/ISE Dataset Development |
Bharath Donthi,
Lingjiao Qi |
source |
9 |
| PharmaSUG |
2019 |
Common Pinnacle 21 Report Issues: Shall we Document or Fix? |
Ajay Gupta |
source |
11 |
| PharmaSUG |
2019 |
Compare and conquer SDTM coding |
Phaneendhar Gondesi |
source |
5 |
| PharmaSUG |
2019 |
Dataset Specifications: Recipes for Efficiency and Quality |
David A. Scocca |
source |
7 |
| PharmaSUG |
2019 |
Homogenizing Unique and Complex data into Standard SDTM Domains with TAUGs |
Sowmya Srinivasa Mukundan,
Charumathy Sreeraman |
source |
10 |
| PharmaSUG |
2019 |
Implementing CDISC Standards for Device-Drug Studies |
Karin LaPann,
Wenying Tian |
source |
10 |
| PharmaSUG |
2019 |
Implementing Laboratory Toxicity Grading for CTCAE Version 5 |
Keith Shusterman,
Mario Widel |
source |
11 |
| PharmaSUG |
2019 |
Interactive TLFs - A Smarter Way to Review your Statistical Outputs |
Bhavin Busa |
source |
5 |
| PharmaSUG |
2019 |
Joining the SDTM and the SUPPxx Datasets |
David W. Franklin |
source |
9 |
| PharmaSUG |
2019 |
Leveraging Intermediate Data Sets to Achieve ADaM Traceability |
Yun (Julie) Zhuo |
source |
12 |
| PharmaSUG |
2019 |
More Traceability: Clarity in ADaM Metadata and Beyond |
Wayne Zhong,
Richann J. Watson,
Daphne E. Ewing,
Jasmine Zhang |
source |
26 |
| PharmaSUG |
2019 |
Pacemaker Guy: De-Mystifying a Business Use Case for SDTM Standard and Medical Device Domains |
Carey G. Smoak,
Donna Sattler,
Fred Wood |
source |
10 |
| PharmaSUG |
2019 |
Practices in CDISC End-to-End Streamlined Data Processing |
Chengxin Li |
source |
14 |
| PharmaSUG |
2019 |
Process optimization for efficient and smooth e-data submissions to both FDA and PMDA |
Eri Sakai,
Malla Reddy Boda,
Akari Kamitani,
Yoshitake Kitanishi |
source |
13 |
| PharmaSUG |
2019 |
Raising the Bar: CDASH implementation in a biometrics CRO |
Julie Barenholtz |
source |
4 |
| PharmaSUG |
2019 |
The Application of SAS-Excel Handshake in DDT |
Maggie Ci Jiang |
source |
7 |
| PharmaSUG |
2019 |
Tool Development Methods for Implementing and Converting to New Controlled Terminology in SDTM datasets |
Martha O'Brien,
Keith Shusterman |
source |
10 |
| PharmaSUG |
2019 |
Vendor's Guide to Consistent, Reliable, and Timely CDISC Deliverables |
Dharmendra Tirumalasetti,
Santosh Reddy Lekkala,
Bhavin Busa |
source |
5 |
| PharmaSUG |
2019 |
What-s New in the SDTMIG v3.3 and the SDTM v1.7 |
Fred Wood |
source |
13 |
| PharmaSUG |
2019 |
When biomarker drives primary endpoint: An oncology case study of SDTM design using multiple myeloma. |
Girish Kankipati,
Bhargav Koduru |
source |
5 |
| PHUSE US |
2019 |
CDISC in Phase I/II Studies: Case Studies in Adopting Standards |
Emily Woolley,
Amber Randall Scharp |
source
presentation source |
7 |
| PHUSE US |
2019 |
Check Your Data: Tools for Automating Data Assessment |
Paul Stutzman |
source
presentation source |
10 |
| PHUSE US |
2019 |
End-to-End SDTM Automation: A Metadata-centric Approach |
Roman Radelicki,
Swapna Pothula |
source
presentation source |
12 |
| PHUSE US |
2019 |
Evolving CDISC to the Next Decades: The CDISC Proof of Concept |
Peter Van Reusel,
Samuel Hume |
source
presentation source |
3 |
| PHUSE US |
2019 |
Formedix On: Advanced Metadata Management Now With Data! [presentation] |
Kevin Burges,
Steven Benham |
source |
45 |
| PHUSE US |
2019 |
From Source Data to SDTM: Enabling a Semi-automated Conversion |
Pieter Blomme |
source
presentation source |
4 |
| PHUSE US |
2019 |
Managing Complexity Towards Submission |
Johannes Ulander |
source
presentation source |
26 |
| PHUSE US |
2019 |
Simplifying the Integration Riddle |
Deepak Ananthan,
Karthik Raja Subbiah |
source
presentation source |
6 |
| PHUSE US |
2019 |
Stay Relaxed... A Utility to Auto-create Specification! |
Kaveri Pachiappan |
source
poster source |
7 |
| PHUSE US |
2019 |
Streamline Process: To Generate SDTM Programs by Automation |
Hemalatha Elumalai |
source
poster source |
8 |
| 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 |
A Critique of the Use of the Medical Device SDTM Domains in the Therapeutic Area User Guides |
Carey G. Smoak |
source
presentation source |
8 |
| PHUSE EU |
2018 |
Automating SDTM - Get it Prepared with Your Voice |
Akhil Vijayan,
Anoop Ambika |
source
presentation source |
8 |
| PHUSE EU |
2018 |
Can You Cut It? Implementing the Data Cut-off |
Lewis Meares |
source
presentation source |
9 |
| PHUSE EU |
2018 |
Easing Your Pain with Biomedical Concepts |
Kirsten Langendorf |
source
presentation source |
12 |
| PHUSE EU |
2018 |
How to Manage Changes to CDISC Standards |
Sune Dandanell,
Mikkel Traun |
source
presentation source |
4 |
| PHUSE EU |
2018 |
How to Write ADaM Specifications Like a Ninja |
Caroline Francis |
source
poster source |
5 |
| PHUSE EU |
2018 |
Implementation of Data Cut Off in Analysis of Clinical Trials |
Ann Croft |
source
presentation source |
13 |
| PHUSE EU |
2018 |
Into the Fire Linking CDISC & FHIR |
David Iberson-Hurst |
source
presentation source |
11 |
| PHUSE EU |
2018 |
Optimizing the Traceability Method in ADaM Parallel Conversions |
Roxane Debrus |
source
presentation source |
15 |
| PHUSE EU |
2018 |
Overcoming Resistance to Technology Change: A Linked Data Perspective |
Tim P. Williams |
source
presentation source |
8 |
| PHUSE EU |
2018 |
Please Put Your Data in an Upright Position - Or How to Tackle Verticalisation |
Kristina Zweier |
source
presentation source |
9 |
| PHUSE EU |
2018 |
SAS and UNIX: Rerun Your Batches in a Smarter Way |
Yaroslav Haiovyi |
source
presentation source |
19 |
| 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 |
The interpretation and development of SDTM standards for non-submission purposes |
Paul Vervuren |
source
presentation source |
11 |
| PHUSE EU |
2018 |
ValueListDefs, MethodDefs and WhereClauses: How to Define Data Traceability in a Metadata Repository |
Judith Goud |
source
presentation source |
11 |
| SESUG |
2018 |
A Macro to Add SDTM Supplemental Domain to Standard Domain |
Pratap Singh Kunwar |
source |
6 |
| SESUG |
2018 |
A User Defined SDTM Data Quality Checking and Tracking System |
Zemin Zeng,
Yunzhi Ling |
source |
6 |
| SESUG |
2018 |
Are You Ready for It? Preparing for Your Next Technical Interview |
Christine McNichol |
source |
6 |
| SESUG |
2018 |
SDTM - Just a Walk in the (Theme) Park, Exploring SDTM in the Most Magical Place on Earth |
Magical Place |
source |
10 |
| SESUG |
2018 |
Tips on Developing SDTM Datasets for Complex Long-Term Safety Studies |
Yunzhi Ling,
Helen Wang |
source |
7 |
| MWSUG |
2018 |
Avoiding Sinkholes: Common Mistakes During ADaM Data Set Implementation |
Richann J. Watson |
|
15 |
| WUSS |
2018 |
CDISC in Phase I/II Studies: Approaches to adopting standards for CSR deliverables |
Emily Woolley,
Amber Randall |
source |
9 |
| PHUSE US |
2018 |
Automated Creation of Submission-Ready Artifacts |
Lourdes Devenney,
Silas McKee |
source
presentation source |
5 |
| PHUSE US |
2018 |
Business-based Value in an MDR |
Manori Turmel,
Brooke Hinkson |
source
presentation source |
11 |
| PHUSE US |
2018 |
Comparing and Contrasting Differences between the PHUSE SDSP and CBER Checklist |
Janet Low,
Pritesh Solanki |
source
presentation source |
5 |
| PHUSE US |
2018 |
Confusing Data Validation Rules Explained |
Michael Beers |
source
presentation source |
5 |
| PHUSE US |
2018 |
Easing Your Pain with Biomedical Concepts |
Kirsten Langendorf |
source
presentation source |
13 |
| PHUSE US |
2018 |
How do I have ONE Interpretation of CDISC for all my Studies? |
Mor Meyerovich |
source
presentation source |
5 |
| PHUSE US |
2018 |
It's Time To Change |
David Iberson-Hurst |
source |
14 |
| PHUSE US |
2018 |
Secure Data Office: An Independent Team that Can Come to the Rescue in Blinded Trials |
Annelies Van Zeveren,
Yana Hoorne |
source
presentation source |
9 |
| PHUSE US |
2018 |
Split-Coalesce Tumor Data Handling Woes and Safety-Efficacy Dilemma |
Idya Muthukumar |
source
presentation source |
11 |
| PHUSE US |
2018 |
Supporting a Data Review and Visualization Application with SDTM |
Deepika Sunkara,
Jagadish Dhanraj |
source
presentation source |
6 |
| PHUSE US |
2018 |
The First and Last Words of ADaM |
Susan J. Kenny |
source |
4 |
| PHUSE US |
2018 |
The Untapped Potential of the Protocol Representation Model |
Jeffrey M. Abolafia,
Frank C. DiIorio |
source
presentation source |
10 |
| PHUSE US |
2018 |
Transforming Clinical Trials with Linked Data |
Tim P. Williams,
Armando Oliva |
source
presentation source |
9 |
| PHUSE US |
2018 |
Want Submission-Ready Datasets Package from the Get-Go? |
Kishore Pothuri,
Bhavin Busa |
source |
7 |
| PharmaSUG |
2018 |
A Critique of the Use of the Medical Device SDTM Domains in Therapeutic Area User Guides |
Carey G. Smoak |
source |
10 |
| PharmaSUG |
2018 |
A time saving approach to track data issues |
Aishhwaryapriya Elamathivadivambigai |
source |
8 |
| PharmaSUG |
2018 |
An alternate way to create the standard SDTM domains |
Sunil Kumar Pusarla |
source |
8 |
| PharmaSUG |
2018 |
Are You Ready for It? Preparing for Your Next Technical Interview |
Christine McNichol |
source |
6 |
| PharmaSUG |
2018 |
Automatically Configure SDTM Specifications Using SAS and VBA |
Xingxing Wu |
source |
15 |
| PharmaSUG |
2018 |
Automation of STDM dataset integration and ADaM dataset formation |
Rinki Jajoo,
William Wei |
source |
11 |
| PharmaSUG |
2018 |
Avoiding Sinkholes: Common Mistakes During ADaM Data Set Implementation |
Richann J. Watson,
Karl Miller |
source |
18 |
| PharmaSUG |
2018 |
Challenges in Implementing Device Related ADaM and SDTM Standards in a Drug-Device Study |
Wenying Tian,
Maureen Maunsell,
Karin LaPann |
source |
9 |
| PharmaSUG |
2018 |
Complexity in collection of PGx data and challenges in mapping to SDTM |
Rama Kudaravalli |
source |
9 |
| PharmaSUG |
2018 |
Confusing Data Validation Rules Explained |
Michael Beers |
source |
6 |
| PharmaSUG |
2018 |
Dosing In NONMEM Datasets an Enigma |
Sree Harsha Sreerama Reddy,
Vishak Subramoney |
source |
11 |
| PharmaSUG |
2018 |
Generating Define.xml from Pinnacle 21 Validator |
Pinky Anandani |
source |
15 |
| PharmaSUG |
2018 |
Implementation of ADaM Basic Data Structure on Genetic Variation Data for Pharmacogenomics Studies |
Linghui Zhang |
source |
10 |
| PharmaSUG |
2018 |
Implementation of Data Cut Off in Analysis of Clinical Trials |
Mei Dey |
source |
15 |
| PharmaSUG |
2018 |
Improving Metadata Compliance and Assessing Quality Metrics with a Standards Library |
Veena Nataraj,
Erica Davis |
source |
9 |
| PharmaSUG |
2018 |
Know your PET: From the Scans to SDTM Datasets |
Balavenkata Pitchuka,
Bhargav Koduru |
source |
8 |
| PharmaSUG |
2018 |
Standardization Efforts at Medtronic, its benefits and Lessons Learned |
Firdouse Fathima |
source |
4 |
| PharmaSUG |
2018 |
Stay ahead of the game: Know the SDTM compliance check reject messages before creating your SDTM datasets |
Lixiang Larry Liu,
Yuqin Li |
source |
6 |
| PharmaSUG |
2018 |
Traceability: Some Thoughts and Examples for ADaM Needs |
Richann J. Watson,
Kent Letourneau,
Wayne (Weizhen) Zhong,
Sandra Minjoe |
source |
18 |
| PharmaSUG |
2018 |
Want Submission-Ready Datasets Package from the Get-Go? |
Kishore Pothuri,
Bhavin Busa |
source |
8 |
| SESUG |
2017 |
Challenges and Solutions for Handling Re - screened Subjects in SDTM |
Charity Quick,
Paul Nguyen |
source |
6 |
| SESUG |
2017 |
One Project, Two Teams: The Unblind Leading the Blind |
Kristen Reece Harrington |
source |
5 |
| SESUG |
2017 |
Timing Variables In Clinical Trials: Avoiding Common Mistakes And Dealing With Unforeseen Issues |
Gregory Weller |
source |
4 |
| PHUSE EU |
2017 |
Breaking the Mould: Clinical Trials Data as RDF |
Tim P. Williams,
Armando Oliva |
source
presentation source |
6 |
| PHUSE EU |
2017 |
GUI Method of Mapping SDTM from Raw Data |
Elisa Natale |
source
presentation source |
7 |
| PHUSE EU |
2017 |
Mapping of Gastrointestinal Tolerance Data to SDTM |
Lieke Gijsbers |
source
presentation source |
5 |
| PHUSE EU |
2017 |
Robust Study Database Build: An Effective Start Towards Creation of Quality SDTMs |
Onkar Tajarekar |
source
presentation source |
9 |
| PHUSE EU |
2017 |
SDTM Domains by Query - is it Possible? |
Johannes Ulander |
source
presentation source |
8 |
| PHUSE EU |
2017 |
Streamline SDTM Development and QC |
Stephen Gormley |
source
presentation source |
9 |
| PHUSE EU |
2017 |
The Secure Data Office Concept |
Annemie Van Dijck |
source
presentation source |
9 |
| PHUSE EU |
2017 |
The Untapped Potential of the Protocol Representation Model |
Jeffrey M. Abolafia,
Frank C. DiIorio |
source
presentation source |
10 |
| PHUSE EU |
2017 |
Use of Fast Healthcare Interoperability Resources (FHIR) in the Generation of Real-World Evidence |
Trisha Simpson,
Regina Zopf |
source
presentation source |
12 |
| PHUSE EU |
2017 |
Visualising CDSIC SDTM for Monitoring and Review |
Philip Bartle |
source
presentation source |
11 |
| PHUSE EU |
2017 |
Worst CDISC Implementation Processes - How to Avoid Some Very Basic Mistakes in SDTM ADaM Define |
Hannes Engberg Reader,
Michale Riech |
source
presentation source |
10 |
| WUSS |
2017 |
Avoiding Sinkholes: Common Mistakes During ADaM Data Set Implementation |
Richann J. Watson,
Karl Miller |
source |
15 |
| PharmaSUG CN |
2017 |
Assigning VISITNUM and EPOCH [presentation] |
Na Duan,
Ru He |
|
32 |
| PharmaSUG CN |
2017 |
Constructive Practice of Generating ADaM Datasets |
Amos Shu |
|
7 |
| PharmaSUG |
2017 |
A novel method to track mapping of all CRF variables into SDTM datasets. |
Aishhwaryapriya Elamathivadivambigai |
source |
7 |
| PharmaSUG |
2017 |
A SASsy Study of eDiary Data |
Amie Bissonett |
source |
5 |
| PharmaSUG |
2017 |
An Efficient Solution to Efficacy ADaM Design and Implementation |
Chengxin Li,
Zhongwei Zhou |
source |
7 |
| PharmaSUG |
2017 |
Check Your Data: Tools for Automating Data Assessment |
Paul Stutzman |
source |
12 |
| PharmaSUG |
2017 |
Gray Areas of ADaM and Ways to Provide Color [presentation] |
Susan J. Kenny,
Sandra Minjoe,
Nate Freimark,
Jack Shostak,
John K. Troxell,
Deborah J. Bauer |
source |
38 |
| PharmaSUG |
2017 |
Harmonizing CDISC Data Standards across Companies: A Practical Overview with Examples |
Keith Shusterman,
Prathima Surabhi,
Binoy Varghese |
source |
6 |
| 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 |
One Project, Two Teams: The Unblind Leading the Blind |
Kristen Reece Harrington |
source |
5 |
| PharmaSUG |
2017 |
Planning to Pool SDTM by Creating and Maintaining a Sponsor-Specific Controlled Terminology Database |
Cori Kramer,
Ragini Hari,
Keith Shusterman |
source |
7 |
| PharmaSUG |
2017 |
RELREC - SDTM Programmer-s Bermuda Triangle |
Charumathy Sreeraman |
source |
12 |
| PharmaSUG |
2017 |
SDTM - Just a Walk in the (Theme) Park, Exploring SDTM in the Most Magical Place on Earth |
Christine McNichol |
source |
9 |
| PharmaSUG |
2017 |
The Benefits of Traceability Beyond Just From SDTM to ADaM in CDISC Standards |
Maggie Ci Jiang |
source |
8 |
| PharmaSUG |
2017 |
The Untapped Potential of the Protocol Representation Model |
Frank C. DiIorio,
Jeffrey M. Abolafia |
source |
10 |
| SGF |
2017 |
Automate Validation of CDISC SDTM with SAS |
Sy J. Truong |
source |
11 |
| SGF |
2017 |
Automatically Map CDASH Data to the Study Data Tabulation Model (SDTM) Structure |
Hao Xu,
Hong Chen |
source |
18 |
| SESUG |
2016 |
SDTM What? ADaM Who? A Programmer's Introduction to CDISC |
Venita DePuy |
source |
9 |
| PHUSE EU |
2016 |
DIY: Create Your Own SDTM Mapping Framework |
Bas van Bakel |
source
presentation source |
11 |
| PHUSE EU |
2016 |
Efficiency comes From Reusability and Repeatability |
Hanming Tu,
Dave Evans |
source
presentation source |
10 |
| PHUSE EU |
2016 |
From SDTM to Displays, through ADaM & Analysis Results Metadata, a Flight on Board Metadata Airlines |
Omar Sefiani,
Stéphane Bouget |
source
presentation source |
10 |
| PHUSE EU |
2016 |
Get a JumpStart on Clinical Data Analysis and Visualisation with Standard Scripts |
Jared Slain,
Hanming Tu |
source
presentation source |
20 |
| PHUSE EU |
2016 |
Japanese Electronic Submission in CDISC Formats |
Takashi Kitahara |
source
presentation source |
8 |
| PHUSE EU |
2016 |
Protocol Representation: The Forgotten CDISC Model |
Jeffrey M. Abolafia,
Frank C. DiIorio |
source
presentation source |
10 |
| PHUSE EU |
2016 |
QC of the aCRF Using SAS |
Rune Pedersen,
Niels Both |
source
presentation source |
12 |
| PHUSE EU |
2016 |
Use of Fast Healthcare Interoperability Resources (FHIR) in the Generation of Real World Evidence (RWE) |
Regina Zopf,
Jeffrey M. Abolafia,
Bhargava Reddy |
source
presentation source |
12 |
| MWSUG |
2016 |
Pre-Data Checks for SDTM Development |
Abhinav Srivastva |
|
10 |
| WUSS |
2016 |
Are you ready for Dec 17th, 2016 - CDISC compliant data submission? |
Kevin Lee |
source |
6 |
| WUSS |
2016 |
Why and What Standards for Oncology Studies (Solid Tumor, Lymphoma and Leukemia)? |
Kevin Lee |
source |
7 |
| PharmaSUG |
2016 |
A Macro to Automatically Flag Baseline in SDTM |
Taylor Markway |
source |
8 |
| PharmaSUG |
2016 |
A Practical Approach to Re-sizing Character Variable Lengths for FDA Submission Datasets (both SDTM and ADaM) |
Xiangchen (Bob) Cui,
Min Chen |
source |
19 |
| PharmaSUG |
2016 |
A SAS Macro Tool to Automate Generation of Define.xml V2.0 from SDTM Specification for FDA Submission |
Min Chen,
Xiangchen (Bob) Cui |
source |
24 |
| PharmaSUG |
2016 |
Automatic Consistency Checking of Controlled Terminology among SDTM Datasets, Define.xml, and NCI/CDISC Controlled Terminology for FDA Submission |
Min Chen,
Xiangchen (Bob) Cui |
source |
13 |
| PharmaSUG |
2016 |
Building Efficiency and Quality in SDTM Development Cycle |
Kishore Pothuri,
Bhavin Busa |
source |
6 |
| PharmaSUG |
2016 |
Consider Define.xml Generation during Development of CDISC Dataset Mapping Specifications |
Vara Prasad Reddy Sakampally,
Bhavin Busa |
source |
6 |
| PharmaSUG |
2016 |
Creating Time to Event ADaM Dataset for a Complex Efficacy Endpoint in Multiple Sclerosis Therapeutic Area |
Ittai Rambach |
source |
8 |
| PharmaSUG |
2016 |
Efficient Safety Assessment in Clinical Trials using the Computer-generated AE Narratives of JMP Clinical |
Richard C. Zink,
Drew Foglia |
source |
13 |
| PharmaSUG |
2016 |
Good versus Better SDTM: Data Listings |
Mario Widel,
Henry B. Winsor |
source |
11 |
| PharmaSUG |
2016 |
Handling Interim and Incomplete Data in a Clinical Trials Setting |
Paul Stutzman |
source |
13 |
| PharmaSUG |
2016 |
Importance of Niche Provider for Successful NDA Submission: Rescue Case Study |
Aparna Poona,
Bhavin Busa,
Tim Southwick |
source |
9 |
| PharmaSUG |
2016 |
Preparing Legacy Format Data for Submission to the FDA - When & Why Must I Do It, What Guidance Should I Follow? |
David C. Izard |
source |
11 |
| PharmaSUG |
2016 |
SDTM Automation with Standard CRF Pages |
Taylor Markway |
source |
10 |
| PharmaSUG |
2016 |
Strategic Considerations for CDISC Implementation |
Amber Randall,
William Coar |
source |
6 |
| PharmaSUG |
2016 |
Tips and tricks when developing Trial Design Model Specifications that provide Reductions in Creation time |
Ruth Marisol Rivera Barragan |
source |
10 |
| PharmaSUG |
2016 |
To IDB or Not to IDB: That is the Question |
Kjersten Offenbecker,
Beth Seremula |
source |
7 |
| PharmaSUG |
2016 |
Transforming Biomarker Data into an SDTM based Dataset |
Kiran Cherukuri |
source |
7 |
| PHUSE EU |
2015 |
Errors Beyond Open CDISC Validator |
Gayatri Karkera,
Nehan Mohan |
source
presentation source |
4 |
| PHUSE EU |
2015 |
How a Clinical Data Repository can Support Pharmacovigilance |
Panteleo Nacci |
source
presentation source |
7 |
| PHUSE EU |
2015 |
Improving CDISC SDTM Data Quality & Compliance Right from the Beginning |
Bharat Chaudhary,
Padamsimh Balekundri |
source
presentation source |
9 |
| PHUSE EU |
2015 |
PHUSE De-identification Working Group: Providing identification Standards to CDISC Data Models |
Jean-Marc Ferran,
Khaled El Eman |
source
presentation source |
13 |
| 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 CN |
2015 |
Tips for efficient CDISC eCRT production |
Lanting Li,
Yu Zhu,
Yuejuan Meng,
Huan Zhu |
|
11 |
| PharmaSUG |
2015 |
A Toolkit to Create a Dynamic Excel Format Metadata to Assist SDTM Mapping Process |
Huei-Ling Chen,
Helen Wang |
source |
11 |
| PharmaSUG |
2015 |
Begin with the End in Mind - Using FDA Guidance Documents as Guideposts when Planning, Delivering and Archiving Clinical Trials |
David C. Izard |
source |
12 |
| PharmaSUG |
2015 |
Considerations in Conforming Data from Multiple Implantable Medical Devices to CDISC Standards Using SAS |
Julia Yang |
source |
9 |
| PharmaSUG |
2015 |
DIABETES: Submission Data Standards and Therapeutic End Points |
Naveed M Khaja |
source |
9 |
| PharmaSUG |
2015 |
Improving Data Quality - Missing Data Can Be Your Friend! |
Julie Chen |
source |
12 |
| PharmaSUG |
2015 |
SDTM TE, TA, and SE Domains: Demystifying the Development of SE |
Kristin Kelly,
Fred Wood,
Jerry Salyers |
source |
6 |
| PharmaSUG |
2015 |
Subset without Upsets: Concepts and Techniques to Subset SDTM Data |
Jhelum Naik,
Sajeet Pavate |
source |
6 |
| PharmaSUG |
2015 |
The Implementation of Display Auto-Generation with Analysis Results Metadata Driven Method |
Chengxin Li |
source |
11 |
| PharmaSUG |
2015 |
Tips on Creating a Strategy for a CDISC Submission |
Rajkumar Sharma |
source |
5 |
| PharmaSUG |
2015 |
Using SAS Clinical Data Integration to Roundtrip a Complete Study Study Metadata (Define-XML) and Study Data (Dataset-XML) |
Ken Ellis |
source |
19 |
| SESUG |
2014 |
SDTM What? ADaM Who? A Programmer's Introduction to CDISC |
Venita DePuy |
source |
9 |
| PHUSE EU |
2014 |
ADaM Conversions: The Good, The Bad and The Ugly |
Carla Santillán,
Jessica Minuke |
source
presentation source |
11 |
| PHUSE EU |
2014 |
Discover Define-XML |
Mark Wheeldon,
Kevin Burges |
source
presentation source |
12 |
| PHUSE EU |
2014 |
From ODM to SDTM: An End-to-End Approach Applied to Phase I Clinical Trials |
Alexandre Mathis |
source
presentation source |
5 |
| PHUSE EU |
2014 |
Implementation of Oncology Specific SDTM Domains |
Jacintha Eben |
source
presentation source |
8 |
| PHUSE EU |
2014 |
Looking for SDTM Migration Specialist |
Angelo Tinazzi |
source
presentation source |
12 |
| PHUSE EU |
2014 |
SDTM in Business Intelligence |
Mike Collinson |
source
presentation source |
3 |
| PHUSE EU |
2014 |
SDTM Mapping Becomes more EASY with SAS Clinical Data Integration |
Saumilkumar Tripathi |
source
presentation source |
8 |
| PharmaSUG CN |
2014 |
Brief Introduction of Oncology Domains in SDTMIG,Version 3.2 |
Haishan Kadeerbai |
|
3 |
| PharmaSUG CN |
2014 |
Submission of Pharmacokinetics (PK) Data in a CDISC Compliant Format |
Yu Zhu |
|
9 |
| PharmaSUG |
2014 |
A Toolkit to Check Dictionary Terms in SDTM |
Huei-Ling Chen,
Helen Wang |
source |
8 |
| PharmaSUG |
2014 |
Adopted Changes for SDTMIG v3.1.3 and 2013 OpenCDISC Upgrades |
Yi Liu,
Stephen Read |
source |
17 |
| PharmaSUG |
2014 |
CDISC Electronic Submission |
Kevin Lee |
source |
6 |
| PharmaSUG |
2014 |
CDISC Mapping and Supplemental Qualifiers |
Arun Raj Vidhyadharan,
Sunil Mohan Jairath |
source |
6 |
| PharmaSUG |
2014 |
Discover Define-XML |
Mark Wheeldon,
Kevin Burges |
source |
12 |
| PharmaSUG |
2014 |
Forging New SDTM Standards for In-Vitro Diagnostic (IVD) Devices: A Use-Case |
Carey G. Smoak,
Smitha Krishnamurthy,
Mansi Singh,
Sy J. Truong |
source |
6 |
| PharmaSUG |
2014 |
OpenCDISC Validator Implementation: A Complex Multiple Stakeholder Process |
Terek J. Peterson,
Gareth Adams |
source |
9 |
| PharmaSUG |
2014 |
Referencing Medical Device Data in Standard SDTM domains |
Timothy L Bullock,
Ramkumar Krishnamurthy |
source |
7 |
| PharmaSUG |
2014 |
Route to SDTM Implementation in In-Vitro Diagnostic Industry: Simple or Twisted |
Carey G. Smoak,
Sofia Shamas,
Chowdagam Chaitanya,
Don Lim,
Girish Rajeev |
source |
10 |
| PharmaSUG |
2014 |
The New Tradition: SAS Clinical Data Integration |
Vincent J. Amoruccio,
Janet E. Stuelpner |
source |
18 |
| SGF |
2014 |
Converting Clinical Database to SDTM: The SAS Implementation |
Hong Chen |
source |
5 |
| PHUSE EU |
2013 |
Evolving Regulatory Guidance on the Submission of Standardised Data [presentation] |
James R. Johnson |
source |
25 |
| PHUSE EU |
2013 |
Interpreting CDISC ADaM IG Through Users Interpretation |
Angelo Tinazzi |
source
presentation source |
12 |
| PHUSE EU |
2013 |
One Vision, Many Interpretations? |
Todd Case |
source
presentation source |
3 |
| PHUSE EU |
2013 |
SDTM Oncology Domains: From Patient to Data to Narrative |
Kennenth Stolzfus |
source
presentation source |
4 |
| PHUSE EU |
2013 |
Standardising the Standards - The Benefits of Consistency |
Nathan James |
source
presentation source |
6 |
| PHUSE EU |
2013 |
Standards Governance - A First Insight |
Claudia Meurer |
source
presentation source |
6 |
| NESUG |
2013 |
The ADaM Solutions to Non-endpoints Analyses |
Chengxin Li |
|
12 |
| PharmaSUG |
2013 |
A Generic Concept to Handle SDTM (and other CDISC) Data Sets |
Peter Schaefer |
source |
8 |
| PharmaSUG |
2013 |
Data Standards Will Be Required: Challenges for Medical Device Submissions |
Carey G. Smoak,
Kit Howard,
Fred Wood,
Rhonda Facile |
source |
5 |
| PharmaSUG |
2013 |
Derived observations and associated variables in ADaM datasets |
Arun Raj Vidhyadharan |
source |
7 |
| PharmaSUG |
2013 |
From Standards that Cost To Standards that Save: Cost Effective Standards Implementation |
Jeffrey M. Abolafia,
Frank C. DiIorio |
source |
9 |
| PharmaSUG |
2013 |
Just Press the Button: Generation of SAS Code to Create Analysis Datasets directly from an SAP - Can it be Done? |
Endri Endri,
Rowland Hale |
source |
8 |
| PharmaSUG |
2013 |
Leveraging SDTM Standards to Cut Datasets at Any Visit |
Anthony L. Feliu,
Stephen W. Lyons |
source |
12 |
| PharmaSUG |
2013 |
Mapping Unique Aspects of Implantable Medical Device Study Data to CDISC SDTM Medical Device Domains |
Timothy L Bullock,
Sini Nair,
Ramkumar Krishnamurthy,
Todd M. Gross |
source |
12 |
| PharmaSUG |
2013 |
Programming Validation Tips prior to using OpenCDISC validator |
Dany Guerendo |
source |
12 |
| PharmaSUG |
2013 |
SDTM Harmonization in the Absence of CDASH - A Modularized Approach to Domain Programming |
Annie S. Guo |
source |
12 |
| PharmaSUG |
2013 |
Some Strategies for Validating Your Data before Submission |
Frank L. Roediger,
Sandeep Juneja |
source |
8 |
| PharmaSUG |
2013 |
Standardizing the Standards: A Road Map for Establishing, Implementing and Unifying Standards in Your Organization |
Amy Caison,
Jhelum Naik,
Tammy Jackson |
source |
9 |
| PharmaSUG |
2013 |
Traceability in the ADaM Standard |
Ed Lombardi |
source |
8 |
| SGF |
2013 |
Developing Your SDTM Programming Toolkit |
David A. Scocca |
source |
10 |
| SGF |
2013 |
From SDTM to ADaM |
Bob Lan,
Regan Li,
Sai Ma,
Suwen Li |
source
pdf |
7 |
| SGF |
2013 |
Using the ADaM ADAE Structure for Non-AE Data |
Mario Widel,
Sandra Minjoe |
source |
13 |
| SCSUG |
2012 |
POSTER: ADaM Implications of the CDER Data Standards Common Issues Document |
Sandra Minjoe |
source |
6 |
| PHUSE EU |
2012 |
Considerations for CSR Output Production from ADaM Datasets |
Andrew Noller |
source
presentation source |
1 |
| PHUSE EU |
2012 |
Cost Effective Standards Implementation: A New Paradigm for the Drug Development Life Cycle |
Jeff Abolafio,
Frank C. DiIorio |
source
presentation source |
9 |
| PHUSE EU |
2012 |
Interpreting ADaM Standards with OpenCDISC |
Trupti Bal,
Madhura Paranjape |
source
presentation source |
8 |
| PHUSE EU |
2012 |
Mapping the Company's Legacy Data Model to SDTM |
Anja Feuerbacher,
Bruce Rogers |
source
presentation source |
7 |
| SESUG |
2012 |
A SAS Macro Approach to Assign CTCAE Grades to Laboratory |
Mei Dey,
Lisa Pyle |
source |
10 |
| SESUG |
2012 |
The SDTM Programming Toolkit |
David A. Scocca |
source |
10 |
| WUSS |
2012 |
Developing Integrated Summary of Safety Database using CDISC Standards |
Rajkumar Sharma |
source |
7 |
| PharmaSUG |
2012 |
"Analysis-ready" - Considerations, Implementations, and Real World Applications |
Ellen (Zihui) Lin,
Beiying Ding |
source |
6 |
| PharmaSUG |
2012 |
A Complex ADaM dataset? Three different ways to create one. |
Kevin Lee |
source |
11 |
| PharmaSUG |
2012 |
ADaM Implications from the "CDER Data Standards Common Issues" and SDTM Amendment 1 Documents |
Sandra Minjoe |
source |
6 |
| PharmaSUG |
2012 |
An Innovative ADaM Programming Tool for FDA Submission |
Xiangchen (Bob) Cui,
Min Chen,
Tathabbai Pakalapati |
source |
25 |
| PharmaSUG |
2012 |
Automatic Consistency Checking of Controlled Terminology and Value Level Metadata between ADaM Datasets and Define.xml for FDA Submission |
Xiangchen (Bob) Cui,
Min Chen |
source |
15 |
| PharmaSUG |
2012 |
Automatic Detection and Identification of Variables with All Missing Values in SDTM/ADaM Datasets for FDA Submission |
Min Chen,
Xiangchen (Bob) Cui |
source |
7 |
| PharmaSUG |
2012 |
CDISC ADaM Application: Does All One-Record-per-Subject Data Belong in ADSL? |
Sandra Minjoe |
source |
10 |
| PharmaSUG |
2012 |
Common Misunderstandings about ADaM Implementation |
Nate Freimark,
Susan J. Kenny,
Jack Shostak,
John K. Troxell |
source |
10 |
| PharmaSUG |
2012 |
Creating an Integrated Summary of Safety Database using CDISC ADaM : Challenges, Tips and Things to Watch Out |
Rajkumar Sharma |
source |
7 |
| PharmaSUG |
2012 |
Creating Analysis Data Marts from SDTM Warehouses |
Frank L. Roediger |
source |
9 |
| PharmaSUG |
2012 |
Metadata: Some Fundamental Truths |
Frank C. DiIorio |
source |
10 |
| PharmaSUG |
2012 |
SDTM Domain Development on the Critical Path - Strategies for Success |
David C. Izard |
source |
5 |
| PharmaSUG |
2012 |
SDTM Domain Mapping with Structured Programming Methodology |
Chengxin Li,
Jing-Wei Gao,
Nancy Bauer |
source |
8 |
| PharmaSUG |
2012 |
Seven New SDTM Domains for Medical Devices |
Carey G. Smoak,
Fred Wood,
Rhonda Facile,
Kit Howard |
source |
4 |
| PharmaSUG |
2012 |
Transform Incoming Lab Data into SDTM LB Domain with Confidence |
Anthony L. Feliu |
source |
27 |
| SGF |
2012 |
Automatic Consistency Checking of Controlled Terminology and Value Level Metadata between ADaM Datasets and Define.xml for FDA Submission |
Xiangchen (Bob) Cui,
Min Chen |
source |
15 |
| SGF |
2012 |
Examples of Building Traceability in CDISC ADaM Datasets for FDA Submission |
Xiangchen (Bob) Cui,
Hongyu Liu,
Tathabbai Pakalapati |
source |
14 |
| SGF |
2012 |
SUPPQUALWhere's My Mommy? |
Sandra VanPelt Nguyen |
source |
8 |
| SESUG |
2011 |
Resolving OpenCDISC Error Messages Using SAS |
John R. Gerlach |
source |
11 |
| WUSS |
2011 |
How to easily convert clinical data to CDISC SDTM |
Ale Gicqueau |
source |
9 |
| WUSS |
2011 |
Use CDISC SDTM as a data middle-tier to streamline your SAS infrastructure |
Kalyani Chilukuri |
source |
8 |
| PHUSE EU |
2011 |
"Overnight" Conversion to SDTM Datasets - Ready for SDTM Submission |
Niels Mathiesen |
source
presentation source |
7 |
| PHUSE EU |
2011 |
A SAS macro to check SDTM domains against controlled terminology |
Guido Wendland |
source
presentation source |
10 |
| 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 |
Extension of the Six Steps Approach: How to go from an SDTM finding domain to an ADaM-compliant AD |
Carl Herremans,
Qian Wang |
source
poster source |
5 |
| PHUSE EU |
2011 |
FDA CDER Common Data Standards Issues: Evolution of SDTM Submission Standards |
Peter Van Reusel,
Tina Apers |
source
presentation source |
3 |
| PHUSE EU |
2011 |
SDTM Domain QS: Challenges and Pitfalls - an Interpretation Guide to the Implementation Guide |
Knut Mueller |
source
presentation source |
6 |
| PHUSE EU |
2011 |
SDTM Implementation Guide - Clear as Mud: Strategies for Developing Consistent Company Standards |
Brian Mabe |
source
presentation source |
5 |
| PHUSE EU |
2011 |
Study Composer: a CRF design tool enabling the re-use of CDISC define.xml metadata |
Philippe Verplancke |
source
presentation source |
5 |
| PHUSE EU |
2011 |
Three Unique Case Studies - On the Trail of the Holy Grail of SDTM Implementation |
Kenneth Stoltzfus |
source
presentation source |
6 |
| MWSUG |
2011 |
How to Use SDTM Definition and ADaM Specifications Documents to Facilitate SAS Programming |
Yan Liu |
|
5 |
| NESUG |
2011 |
A Validation Macro to Check Compliance of CDISC SDTM Data |
Hany Aboutaleb |
|
13 |
| NESUG |
2011 |
Automating SDTM File Creation: Metadata Files Speeding the Process |
Daphne E. Ewing |
|
7 |
| NESUG |
2011 |
Metadata: Some Fundamental Truths |
Frank C. DiIorio |
|
9 |
| PharmaSUG |
2011 |
A Cost-Effective SDTM Conversion for NDA Electronic Submission |
Xiangchen (Bob) Cui,
Scott E. Moseley,
Min Chen |
source |
12 |
| PharmaSUG |
2011 |
Brave New World: How to Adapt to the CDISC Statistical Computing Environment |
Jeffrey M. Abolafia,
Frank C. DiIorio |
source |
11 |
| PharmaSUG |
2011 |
Confessions of a Clinical Programmer: Dragging and Dropping Means Never Having to Say You're Sorry When Creating SDTM Domains |
Janet E. Stuelpner,
Jack Shostak |
source |
12 |
| PharmaSUG |
2011 |
Creating SDTM Datasets from Legacy Data |
Fred Wood |
source |
6 |
| PharmaSUG |
2011 |
Efficiencies Realized in Building and Utilizing ADaM from SDTM |
Shirish Nalavade,
Parag Shiralkar |
source |
5 |
| PharmaSUG |
2011 |
Ensuring Consistent Data Mapping Across SDTM-based Studies - a Data Warehouse Approach |
Annie S. Guo |
source |
12 |
| PharmaSUG |
2011 |
From SAP to BDS: The Nuts and Bolts |
Nancy Brucken,
Paul K. Slagle |
source |
9 |
| PharmaSUG |
2011 |
Method to Derive Reproducible SDTM Relationship Datasets |
Suwen Li,
Sai Ma,
Regan Li,
Bob Lan |
source |
9 |
| PharmaSUG |
2011 |
Methods of Building Traceability for ADaM Data |
Songhui Zhu,
Lin Yan |
source |
9 |
| PharmaSUG |
2011 |
Resolving OpenCDISC Error Messages Using SAS |
Virginia Redner,
John R. Gerlach |
source |
10 |
| PharmaSUG |
2011 |
Truncation, Variable Association, Controlled Terminology, and Some Other Pitfalls in the SDTM Mapping Process |
Na Li,
Gary de Jesus,
Daniel Bonzo |
source |
8 |
| PharmaSUG |
2011 |
Using the ADaM Basic Data Structure for Survival Analysis |
Nancy Brucken,
Sandra Minjoe,
Mario Widel |
source |
5 |
| PharmaSUG |
2011 |
Validating Controlled Terminology in SDTM Domains |
John R. Gerlach |
source |
12 |
| SGF |
2011 |
Confessions of a Clinical Programmer: Dragging and Dropping Means Never Having to Say You're Sorry When Creating SDTM Domains |
Janet E. Stuelpner,
Jack Shostak |
source |
12 |
| SGF |
2011 |
Using SAS to Incorporate the SDTM for a Study Funded by the NIH |
Fenghsiu Su,
Bradford Jackson,
Kaming Lo,
Sumihiro Suzuki,
Karan Singh,
David Coultas |
source |
8 |
| NESUG |
2010 |
Automating SDTM File Creation: Metadata Files Speeding the Process |
Daphne E. Ewing |
|
7 |
| NESUG |
2010 |
Date Conversions in SDTM and ADaM Datasets |
Lily Zhang,
Lili Chen,
Huei-Ling Chen |
|
8 |
| NESUG |
2010 |
Outsourced Data Integration Project with CDISC SDTM and ADaM Deliverables |
Margaret M. Coughlin,
Christine S Teng |
|
11 |
| NESUG |
2010 |
SAS and open source tools for CDISC SDTM compliance checks for regulatory submissions |
Sandeep Kottam,
Peter Loonan,
Sree Lakshmi Kalyani Tripuraneni |
|
4 |
| NESUG |
2010 |
The 5 Biggest Challenges of ADaM |
Terek J. Peterson,
David C. Izard |
|
11 |
| WUSS |
2010 |
Automation of 'makefile' for Use in Clinical Development |
Nalin Tikoo |
source |
7 |
| PHUSE EU |
2010 |
BeST - Bioequivalence Study Template |
Pekka Heikkilä |
source
presentation source |
9 |
| PHUSE EU |
2010 |
CDISC integration in a clinical data management system |
Peter Van Reusel |
source
presentation source |
13 |
| PHUSE EU |
2010 |
From ACE to ZINC |
Paul Vervuren |
source |
8 |
| PHUSE EU |
2010 |
How to go From an SDTM Findings Domain to an ADaM-Compliant Analysis Dataset: An Example |
Carl Herremans |
source
presentation source |
8 |
| PharmaSUG |
2010 |
Applying ADaM Principles in Developing a Response Analysis Dataset |
Mei Dey,
Lisa Pyle |
|
8 |
| PharmaSUG |
2010 |
Checking for SDTM Compliance: The Need for Human Involvement |
Fred Wood,
Adrienne Boyance |
|
8 |
| PharmaSUG |
2010 |
Editing SAS Metadata - Automated From CSV Files Using XML String in SAS Data Integration Studio |
Annie S. Guo |
|
11 |
| PharmaSUG |
2010 |
From SAP to ADaM: The Nuts and Bolts |
Nancy Brucken,
Paul K. Slagle |
|
9 |
| PharmaSUG |
2010 |
Help! The EX Domain is Now an Analysis Dataset! What Do I Do?!? |
David C. Izard |
|
4 |
| PharmaSUG |
2010 |
How to validate SDTM SUPPQUAL Data Set |
Kevin Lee |
|
4 |
| PharmaSUG |
2010 |
In-Depth Review of Validation Tools to Check Compliance of CDISC SDTM-Ready Clinical Datasets |
Bhavin Busa,
Kimberly Lindfield |
|
52 |
| PharmaSUG |
2010 |
In-Depth Review of Validation Tools to Check Compliance of CDISC SDTM-Ready Clinical Datasets |
Bhavin Busa,
Kimberly Lindfield |
|
8 |
| PharmaSUG |
2010 |
Insights into ADaM |
Matthew J. Becker |
|
9 |
| PharmaSUG |
2010 |
Medical Device and Diagnostic Industry 101 |
Carey G. Smoak |
|
5 |
| PharmaSUG |
2010 |
Quality in a World of "Standards" with Differences! |
Sandra VanPelt Nguyen |
|
9 |
| PharmaSUG |
2010 |
The 5 Biggest Challenges of ADaM |
Terek J. Peterson |
|
11 |
| PharmaSUG |
2010 |
The CDISC/FDA Integrated Data Pilot: A Final Summary of Findings, Reviewer Feedback, and Recommendations Implementing CDISC Standards Within and Across Studies |
Chris Decker |
|
20 |
| SGF |
2010 |
Automating SDTM File Creation: Speeding Up the Process with Metadata Files |
Daphne E. Ewing |
source |
7 |
| SGF |
2010 |
Using PROC CONTENTS Output to Perform Quality Control Checks on SDTM Data Sets |
Jennifer M. Srivastava |
source |
6 |
| SESUG |
2009 |
Mapping Nested e-CRF Data into SDTM Domains |
Venkata Sekhar Bhamidipati,
Kristi L. Garner |
source |
5 |
| PHUSE EU |
2009 |
ETL and the Clinical Programmer - They don't have to be Enemies! |
Chris Decker,
Christopher R. Olinger |
source |
11 |
| 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 |
Generate Define.xml & Define.pdf from Metadata Environment |
Rohit Banga |
source
presentation source |
11 |
| PHUSE EU |
2009 |
Implementation of ADaM standards NOT driven by a submission |
Karin Fleischer |
source
presentation source |
7 |
| PHUSE EU |
2009 |
Insights into ADaM |
Matthew J. Becker |
source
presentation source |
9 |
| PHUSE EU |
2009 |
SDTM Validation: How can we do it right? |
Peter Van Reusel |
source
presentation source |
8 |
| PHUSE EU |
2009 |
The CDISC/FDA Integrated Data Pilot: A Case Study in Implementing CDISC Standards to support an Integrated Review |
Chris Decker |
source
presentation source |
15 |
| 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 |
| NESUG |
2009 |
A Proposed SDTM Implementation of Response Data for Solid Tumor Trials in Oncology |
Mei Dey,
Elisabeth Pyle |
|
18 |
| WUSS |
2009 |
CDISC Implementation on a Rheumatoid Arthritis Project Partnership |
Patricia L. Gerend,
Oliver LeConte,
Michelle Zhang,
Chris Price |
source |
9 |
| WUSS |
2009 |
The CDISC Study Data Tabulation Model (SDTM): History, Perspective, and Basics |
Fred Wood |
source |
9 |
| PharmaSUG |
2009 |
Clinically Significant Data Integration Studio |
Chris Decker,
Stephen Baker |
|
12 |
| PharmaSUG |
2009 |
Data Conversion to SDTM: What Sponsors Can Do to Facilitate the Process |
Fred Wood |
|
6 |
| PharmaSUG |
2009 |
Implementation Plan for CDISC SDTM & ADaM Standards at MedImmune |
Alan Meier |
|
11 |
| PHUSE EU |
2008 |
CDISC: Implementation Strategies for SDTM |
Brian Mabe |
source |
5 |
| PHUSE EU |
2008 |
Implementing CDISC at Boehringer Ingelheim |
Michael Knoessl,
Peter Leister |
source |
5 |
| PHUSE EU |
2008 |
In at the Deep-End (thoughts on mapping multiple studies into CDISC for an ISS/ISE) |
Andrew Noller |
source |
7 |
| PHUSE EU |
2008 |
Let SAS HELP Help You |
Catriona O'Hare |
source |
8 |
| PHUSE EU |
2008 |
Practical application of SAS Clinical Data Integration Server for conversion to SDTM data |
Mark Lambrecht,
Peter Van Reusel |
source |
9 |
| PHUSE EU |
2008 |
The application of SDTM in a disease (oncology)-oriented organization |
Angelo Tinazzi,
Enrica Paschetto |
source |
8 |
| PharmaSUG |
2008 |
A SAS based solution for define.xml |
Monika Kawohl |
|
18 |
| PharmaSUG |
2008 |
A Toolkit for CDISC Implementation |
Robert T. Stemplinger |
|
6 |
| PharmaSUG |
2008 |
Case Study: Analysis and Metrics of End-to-End Legacy Data Conversions into SDTM, ADaM, and Define.xml |
Robert T. Stemplinger |
|
5 |
| PharmaSUG |
2008 |
Experiences Submitting CDISC SDTM and Janus Compliant Datasets |
Carol Vaughn,
Gregory Ridge,
William Friggle |
|
10 |
| PharmaSUG |
2008 |
Mission Possible: A Proposed SDTM Domain for the Medical Device and Diagnostic Industry |
Carey G. Smoak |
|
2 |
| PharmaSUG |
2008 |
SDTM, Plus or Minus |
Barry R. Cohen |
|
6 |
| PharmaSUG |
2008 |
The CDISC Study Data Tabulation Model (SDTM): History, Perspective, and Basics |
Fred Wood |
|
8 |
| PharmaSUG |
2008 |
Validating CDISC SDTM-Compliant Submission-Ready Clinical Datasets with an In-House SAS Macro-Based Solution |
Bhavin Busa,
Sheila Vince,
Jameelah Aziz |
|
12 |
| SGF |
2008 |
Practical Methods for Creating CDISC SDTM Data Sets from Existing Data |
Robert W. Graebner |
source |
11 |
| PHUSE EU |
2007 |
A SAS based solution for define.xml |
Monika Kawohl |
source |
18 |
| PHUSE EU |
2007 |
All roads lead to SDTM - which one shall we take? |
Ian Fisher,
Donna Thompson |
source |
9 |
| PHUSE EU |
2007 |
Considerations for CDISC Implementation |
Robert T. Stemplinger,
Jackie Lane |
source |
4 |
| PharmaSUG |
2007 |
A Harmonized, Report-Friendly SDTM and ADaM Data Flow |
Aileen L. Yam |
|
4 |
| PharmaSUG |
2007 |
A Scalable Platform For Clinical Trials - Interoperability And Automation In A Web-Based Environment |
John R. Gerlach,
Maulik Shah |
|
11 |
| PharmaSUG |
2007 |
Considerations for CDISC Implementation |
Robert T. Stemplinger |
|
4 |
| PharmaSUG |
2007 |
Customizing SAS Data Integration Studio to Generate CDISC Compliant SDTM 3.1 Domains |
Tatyana Kovtun,
John Markle,
Christopher Treglio |
|
12 |
| PharmaSUG |
2007 |
Evolution and Implementation of the CDISC Study Data Tabulation Model (SDTM) |
PharmaSUG Annual Meeting,
Fred Wood,
Tom Guinter |
|
47 |
| PharmaSUG |
2007 |
Evolution and Implementation of the CDISC Study Data Tabulation Model (SDTM) |
Fred Wood,
Tom Guinter |
|
7 |
| PharmaSUG |
2007 |
From CRF Data to DEFINE.XML: Going "End to End" with Metadata |
Frank C. DiIorio,
Jeffrey M. Abolafia |
|
20 |
| PharmaSUG |
2007 |
Managing the CRO Relationship to Effectively Request and Receive CDISC STDM and ADaM Deliverables |
Kenneth Eng,
David C. Izard,
Terek J. Peterson |
|
8 |
| PharmaSUG |
2007 |
SDTM, Plus or Minus |
Barry R. Cohen |
|
6 |
| PharmaSUG |
2007 |
Strategies and Practical Considerations for Creating CDISC SDTM Domain Data Sets from Existing CDM Data Sets |
Robert W. Graebner |
|
12 |
| PharmaSUG |
2007 |
Taking a Walk on the Wildside: Use of the PROC CDISC-SDTM 3.1 Format |
William C. Csont,
Howard M. Proskin |
|
6 |
| SGF |
2007 |
The Electronic Project: Effectively Using Metadata throughout the Project Life Cycle |
Jeffrey M. DiIorio,
Frank Abolafia |
source |
18 |
| PHUSE EU |
2006 |
Using CDISC Models for the Analysis of Safety Data |
Susan J. Kenny,
Edward D. Helton |
source |
10 |
| SESUG |
2006 |
A Relational Understanding of SDTM Tables |
John R. Gerlach |
source |
10 |
| NESUG |
2006 |
Using SAS Data Integration Studio to Convert Clinical Trials Data to the CDISC SDTM Standard |
Barry R. Cohen |
|
8 |
| PharmaSUG |
2006 |
Evolution and Implementation of the CDISC Study Data Tabulation Model (SDTM) |
Tom Guinter,
Fred Wood |
|
6 |
| PharmaSUG |
2006 |
Imputing ISO8601 Dates From Character Variables Containing Partial Dates |
John R. Gerlach |
|
4 |
| PharmaSUG |
2006 |
Using SAS ETL Studio to Convert Clinical Trials Data to the CDISC SDTM |
Barry R. Cohen |
|
10 |
| PHUSE EU |
2005 |
Customer oriented CDISC implementation |
Edelbert Arnold,
Ulrike Plank |
source
poster source |
13 |
| PHUSE EU |
2005 |
Visions of a Drug Development Data Warehouse |
Paul Vervuren |
source |
7 |
| PharmaSUG |
2005 |
Implementation of the CDISC SDTM at the Duke Clinical Research Institute |
Jack Shostak |
|
12 |
| PharmaSUG |
2005 |
Strategies for Implementing SDTM and ADaM Standards |
Susan J. Kenny,
Michael A. Litzsinger |
|
8 |
| PharmaSUG |
2005 |
The Role of Analysis Datasets in Successful FDA Advisory Meetings |
Sandy Chang |
|
9 |
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