| PharmaSUG |
2026 |
SDTMIG v4.0: Are You Ready For It? |
|
source |
12 |
| PHUSE US |
2026 |
SDTMIG v4.0: Are You Ready For It? |
|
source
presentation source |
10 |
| PHUSE EU |
2025 |
The Show Must Go On: Best Practices for Submitting SDTM Data for Ongoing Studies |
|
source
presentation source |
8 |
| PharmaSUG |
2025 |
The Show Must Go On: Best Practices for Submitting SDTM Data for Ongoing Studies |
|
source |
9 |
| PHUSE US |
2025 |
The Show Must Go On: Best Practices for Submitting SDTM Data for Ongoing Studies |
|
source
presentation source |
8 |
| PHUSE EU |
2024 |
Guidance Beyond the SDTM Implementation Guide |
|
source
presentation source |
10 |
| PharmaSUG |
2024 |
Guidance Beyond the SDTM Implementation Guide |
Michael Beers |
source |
11 |
| PharmaSUG |
2023 |
'TUFF' LOVE: SDTM Pain Points Explained! |
Michael Beers |
source |
12 |
| PharmaSUG |
2022 |
Explanations in the Study Data Reviewer's Guide: How's It Going? |
|
source |
9 |
| PHUSE US |
2022 |
Explanations in the Study Data Reviewer's Guide: How's It Going? [presentation] |
|
source
video |
13 |
| PHUSE US |
2022 |
Preparing Vaccine Studies for Regulatory Submissions [presentation] |
|
source |
30 |
| PHUSE EU |
2020 |
Getting It Right: Refinement of SEND Validation Rules [presentation] |
|
source
video |
29 |
| PHUSE EU |
2020 |
SDTM Trial Summary Domain Puzzle: Are These the Right Pieces? [presentation] |
|
source
video |
24 |
| PharmaSUG |
2020 |
Getting It Right: Refinement of SEND Validation Rules |
|
source |
7 |
| PHUSE US |
2020 |
Getting It Right: Refinement of SEND Validation Rules |
Blue Bell |
source
presentation source |
6 |
| PHUSE EU |
2019 |
Considerations When Representing Multiple Subject Enrollments in SDTM |
Blue Bell |
source
presentation source |
7 |
| PharmaSUG |
2019 |
Considerations When Representing Multiple Subject Enrollments in SDTM |
Mike Hamidi |
source |
8 |
| PHUSE US |
2019 |
Considerations When Representing Multiple Subject Enrollments in SDTM |
|
source
presentation source |
6 |
| PHUSE EU |
2018 |
Best Practice for Explaining Validation Results in the Study Data Reviewer's Guide |
Michael Beers |
source
presentation source |
8 |
| PHUSE US |
2018 |
Best Practices for Explaining Validation Results in the Study Data Reviewer's Guide |
|
source
presentation source |
6 |
| PharmaSUG |
2018 |
Best Practice for Explaining Validation Results in the Study Data Reviewer's Guide |
|
source |
6 |
| PharmaSUG |
2018 |
SDTM EX and EC: Considerations When Submitting Exposure Data |
Jerry Salyers |
source |
8 |
| PharmaSUG |
2017 |
Documenting Traceability for the FDA: Clarifying the Legacy Data Conversion Plan & Introducing the Study Data Traceability Guide |
David C. Izard,
Jane Lozano |
source |
9 |
| PharmaSUG |
2016 |
Considerations and Conventions within the Therapeutic Area User Guides (TAUGs) |
Jerry Salyers,
Fred Wood |
source |
8 |
| PharmaSUG |
2016 |
SDTM Trial Summary Domain: Putting Together the TS Puzzle |
Jerry Salyers,
Fred Wood |
source |
13 |
| PharmaSUG |
2015 |
SDTM TE, TA, and SE Domains: Demystifying the Development of SE |
Fred Wood,
Jerry Salyers |
source |
6 |
| PharmaSUG |
2014 |
Considerations in the Submission of Exposure Data in SDTM-Based Datasets |
Fred Wood,
Jerry Salyers,
Richard Lewis |
source |
6 |
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