PharmaSUG SDE2018presentation·NC·Sharing Solutions of e-Submissions: Making it Happen, Making it Matter
ADaM 2018: What’s New and What’s Coming 04 North America · RTP, NC
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Conference Papers
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PharmaSUG SDE2018presentation·NC·Sharing Solutions of e-Submissions: Making it Happen, Making it Matter
ADaM Structures for Integration: A Preview 05 North America · RTP, NC
PharmaSUG SDE2018presentation·NC·Sharing Solutions of e-Submissions: Making it Happen, Making it Matter
A Framework for Implementing [Conflicting] FDA Guidance 06 North America · RTP, NC
PharmaSUG SDE2018presentation·NC·Sharing Solutions of e-Submissions: Making it Happen, Making it Matter
Preparing ADaM Datasets and Related Files for FDA Submission 07 North America · RTP, NC
PharmaSUG SDE2018presentation·NC·Sharing Solutions of e-Submissions: Making it Happen, Making it Matter
Define XML Expectations from Various Clients, Tools and Industry Groups 08 North America · RTP, NC
PharmaSUG SDE2018presentation·NC·Sharing Solutions of e-Submissions: Making it Happen, Making it Matter
CDISC Standards: Evolving to Meet Submission Needs 09 North America · RTP, NC
PharmaSUG SDE2016presentation·NC·A CDISC Grab Bag
SEND (The Standard for the Exchange of Nonclinical Data): History, Basics, and Comparisons with Clinical Data 01 North America · RTP, NC
PharmaSUG SDE2016presentation·NC·A CDISC Grab Bag
Associated Persons Domains – Who? What? Where? When? Why? How? 02 North America · RTP, NC
PharmaSUG SDE2016presentation·NC·A CDISC Grab Bag
The Protocol Representation Model: The Forgotten CDISC Model 03 North America · RTP, NC
PharmaSUG SDE2016presentation·NC·A CDISC Grab Bag
CDISC: Interoperability and Beyond… 04 North America · RTP, NC
PharmaSUG SDE2016presentation·NC·A CDISC Grab Bag
My Attempt to Rid the Clinical World of Excel 05 North America · RTP, NC
PharmaSUG SDE2016presentation·NC·A CDISC Grab Bag
ADaM Grouping: Groups, Categories, and Criteria. Which Way Should I Go? 06 North America · RTP, NC
PharmaSUG SDE2016presentation·Chicago·Applying CDISC Standards to Clinical Trials: Experience and Feedback
Proper Parenting: A Guide in Using ADaM Flag/Criterion Variables and When to Create a Child Dataset 01 North America · Chicago, IL
PharmaSUG SDE2016presentation·Chicago·Applying CDISC Standards to Clinical Trials: Experience and Feedback
Using CDISC to Support the Healthy Birth, Growth & Development Knowledge Integration (Gates Foundation Project) 02 North America · Chicago, IL
PharmaSUG SDE2016presentation·Chicago·Applying CDISC Standards to Clinical Trials: Experience and Feedback
An Efficient Way to Create the SDTM TS Domain 03 North America · Chicago, IL
PharmaSUG SDE2016presentation·Chicago·Applying CDISC Standards to Clinical Trials: Experience and Feedback
DS- Disposition, the Role of One Domain 04 North America · Chicago, IL
PharmaSUG SDE2016presentation·Chicago·Applying CDISC Standards to Clinical Trials: Experience and Feedback
No USUBJID? No Problem!: Handling OpenCDISC Reports That Don’t Provide USUBJID 05 North America · Chicago, IL
PharmaSUG SDE2016presentation·Chicago·Applying CDISC Standards to Clinical Trials: Experience and Feedback
Applying SDTM and ADaM to the Construction of Datamarts in Support of Cross-indication Regulatory Requests 06 North America · Chicago, IL
PharmaSUG SDE2016presentation·Chicago·Applying CDISC Standards to Clinical Trials: Experience and Feedback
Some Sightings While Traveling the Road of ADaM Spec Review 07 North America · Chicago, IL
PharmaSUG SDE2016presentation·Chicago·Applying CDISC Standards to Clinical Trials: Experience and Feedback
Considerations in ADaM Occurrence Data: Handling Crossover Records for Non-Typical Analysis 08 North America · Chicago, IL