| PharmaSUG |
2025 |
What comes first, the chicken (ADSL) or the egg (ADNCA)? Modularize your covariate creation to support flexible analysis dataset implementation! |
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source |
6 |
| PharmaSUG |
2024 |
Study Start Date - Let-s Get it Right! |
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6 |
| PHUSE US |
2023 |
Working Together: The Evolving Relationship of Biostatistics & Regulatory for Support of Study Data Standardization Plans and BIMO Reviewer's Guides |
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source presentation source |
3 |
| PHUSE US |
2019 |
Machine-readable Data Not Required for the EMA...Really? |
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source presentation source |
4 |
| PharmaSUG |
2017 |
Documenting Traceability for the FDA: Clarifying the Legacy Data Conversion Plan & Introducing the Study Data Traceability Guide |
Kristin Kelly, Jane Lozano |
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9 |
| PharmaSUG |
2016 |
Preparing Legacy Format Data for Submission to the FDA - When & Why Must I Do It, What Guidance Should I Follow? |
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11 |
| PharmaSUG |
2015 |
Begin with the End in Mind - Using FDA Guidance Documents as Guideposts when Planning, Delivering and Archiving Clinical Trials |
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12 |
| PharmaSUG |
2012 |
SDTM Domain Development on the Critical Path - Strategies for Success |
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source |
5 |
| NESUG |
2010 |
The 5 Biggest Challenges of ADaM |
Terek J. Peterson |
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11 |
| PharmaSUG |
2010 |
Help! The EX Domain is Now an Analysis Dataset! What Do I Do?!? |
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4 |
| PharmaSUG |
2007 |
Managing the CRO Relationship to Effectively Request and Receive CDISC STDM and ADaM Deliverables |
Kenneth Eng, Terek J. Peterson |
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8 |
| PharmaSUG |
2005 |
A Technique for Producing Sorted Columns with a Hanging First Line Using PROC REPORT |
David C. Chen |
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6 |
| PharmaSUG |
2004 |
Automation of Patient Narratives Using SAS and Analysis Datasets |
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6 |
| PharmaSUG |
2002 |
An Automation System for Generating Case Report Form Tabulations |
Shi-Tao Yeh |
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6 |
| PharmaSUG |
2001 |
_hitlist Macro - A Tool to Obtain Consistent Results in an Integrated Database |
Diane E. Foose |
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4 |
| PharmaSUG |
2001 |
Pre-requisite to Effective Validation: Evaluating Your Clinical Trials Software Development Environment Using SEI's Capability Maturity Model for Software |
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8 |