Standard implementation nuances exist across the multiple available versions of SDTM and ADaM. The project team will establish a framework for the collection, compilation, assessment, response to, and publishing of common SDTM and ADaM implementation challenges/nuances. This is important for sponsors who are still transitioning to newer versions of standards (e.g. SDTM), as well as the vast majority who have to govern multiple versions, even for a single product or application. This is a joint project between PHUSE and CDISC. Five primary categorical areas will be used for the FAQ.
Project Leads:
Bhavin Busa - bbusa@vitadatasciences.com
Aatiya Zaidi - aatiya.zaidi@gilead.com
Amy Palmer - apalmer@cdisc.org
Project Scope |
The Standards Implementation Nuances sessions at the March North America 2016 CSS and June EU 2016 CSS surfaced various common challenges amongst SDTM and ADaM implementers and consumers. In addition, there were many questions discussed related to data submissions requirements by various regulatory agencies around the world (e.g. FDA, PMDA, NMPA). It became very clear that the Industry is in need of a forum and subsequent knowledge-base (FAQ) to address these challenges. This project team was formed in June 2016 to collaborate with Subject Matter Experts (SMEs) from the industry, CDISC, and the FDA. The goal of this project team is to:
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| Project Leads | |
|---|---|
| Aatiya Zaidi, Gilead | aatiya.zaidi@gilead.com |
| Amy Palmer | TBC |
| Bhavin Busa, Clymb Clinical | bhavin@clymbclinical.com |
| Nicola Newton, PHUSE Project Assistant |
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| Objectives & Deliverables | Timelines |
|---|---|
Publish responses to questions received under: | Ongoing |
| Published Deliverables | Date |
| Integration Strategies in Support of ISS/ISE Submissions: Version 1.0 | 27-Oct-2020 |
| Best Practices for Submissions of Event Adjudication: Version 1.0 | 02-Dec-2019 |