| PharmaSUG |
2020 |
Trial Sets in Human Clinical Trials |
|
source |
13 |
| PharmaSUG |
2019 |
Pacemaker Guy: De-Mystifying a Business Use Case for SDTM Standard and Medical Device Domains |
Carey G. Smoak, Donna Sattler |
source |
10 |
| PharmaSUG |
2019 |
What-s New in the SDTMIG v3.3 and the SDTM v1.7 |
|
source |
13 |
| PHUSE EU |
2017 |
Considerations and Conventions in the Submission of the SDTM Tumor and Response Domain |
Jerry Salyers |
source presentation source |
7 |
| PharmaSUG |
2017 |
Considerations and Conventions in the Submission of the SDTMIG Tumor and Response Domains |
Jerry Salyers |
source |
7 |
| PharmaSUG |
2017 |
Considerations in Submitting Standardized Electronic Data Under the Animal Rule: The Use of Domains in the SDTMIG and the SENDIG |
|
source |
7 |
| PharmaSUG |
2016 |
Considerations and Conventions within the Therapeutic Area User Guides (TAUGs) |
Jerry Salyers, Kristin Kelly |
source |
8 |
| PharmaSUG |
2016 |
SDTM Trial Summary Domain: Putting Together the TS Puzzle |
Kristin Kelly, Jerry Salyers |
source |
13 |
| PharmaSUG |
2016 |
The Standard for the Exchange of Nonclinical Data (SEND): History, Basics, and Comparisons with Clinical Data |
|
source |
10 |
| PharmaSUG |
2015 |
Considerations in Submitting Non-Standard Variables: Supplemental Qualifiers, Findings About, or a Custom Findings Domain |
Jerry Salyers, Richard Lewis |
source |
6 |
| PharmaSUG |
2015 |
SDTM TE, TA, and SE Domains: Demystifying the Development of SE |
Kristin Kelly, Jerry Salyers |
source |
6 |
| PharmaSUG |
2015 |
What to Expect in SDTMIG v3.3 |
|
source |
10 |
| PharmaSUG |
2014 |
Considerations in Creating SDTM Trial Design Datasets |
Jerry Salyers, Richard Lewis, Kimberly Minkalis |
source |
9 |
| PharmaSUG |
2014 |
Considerations in the Submission of Exposure Data in SDTM-Based Datasets |
Jerry Salyers, Richard Lewis, Kristin Kelly |
source |
6 |
| PharmaSUG |
2014 |
Data Standards Development for Therapeutic Areas: A Focus on SDTM-Based Datasets |
Diane Wold, Rhonda Facile, Wayne Kubick |
source |
10 |
| PharmaSUG |
2013 |
Considerations in Data Modeling when Creating Supplemental Qualifiers Datasets in SDTM-Based Submissions |
|
source |
12 |
| PharmaSUG |
2013 |
Considerations in the Use of Timing Variables in Submitting SDTM-Compliant Datasets |
Jerry Salyers, Richard Lewis |
source |
6 |
| PharmaSUG |
2013 |
Data Standards Will Be Required: Challenges for Medical Device Submissions |
Carey G. Smoak, Kit Howard, Rhonda Facile |
source |
5 |
| PharmaSUG |
2012 |
Considerations in the Submission of Exposure Data in an SDTM-Compliant Format |
Jerry Salyers, Richard Lewis |
source |
4 |
| PharmaSUG |
2012 |
Considerations in the Submission of Pharmacokinetics (PK) Data in an SDTM-Compliant Format |
Peter Schaefer, Richard Lewis |
source |
8 |
| PharmaSUG |
2012 |
Seven New SDTM Domains for Medical Devices |
Carey G. Smoak, Rhonda Facile, Kit Howard |
source |
4 |
| PharmaSUG |
2011 |
Creating SDTM Datasets from Legacy Data |
|
source |
6 |
| PharmaSUG |
2011 |
The Standard for the Exchange of Nonclinical Data (SEND): History and Basics |
Lou Ann Kramer |
source |
9 |
| PharmaSUG |
2011 |
Trials and Tribulations of SDTM Trial Design |
Mary Lenzen |
source |
5 |
| PharmaSUG |
2010 |
Checking for SDTM Compliance: The Need for Human Involvement |
Adrienne Boyance |
|
8 |
| WUSS |
2009 |
The CDISC Study Data Tabulation Model (SDTM): History, Perspective, and Basics |
|
source |
9 |
| PharmaSUG |
2009 |
Data Conversion to SDTM: What Sponsors Can Do to Facilitate the Process |
|
|
6 |
| PharmaSUG |
2008 |
The CDISC Study Data Tabulation Model (SDTM): History, Perspective, and Basics |
|
|
8 |
| PharmaSUG |
2007 |
Evolution and Implementation of the CDISC Study Data Tabulation Model (SDTM) |
PharmaSUG Annual Meeting, Tom Guinter |
|
47 |
| PharmaSUG |
2007 |
Evolution and Implementation of the CDISC Study Data Tabulation Model (SDTM) |
Tom Guinter |
|
7 |
| PharmaSUG |
2006 |
Evolution and Implementation of the CDISC Study Data Tabulation Model (SDTM) |
Tom Guinter |
|
6 |