Medical Devices  

See also CDISC Strategies and SAS® Clinical Standard Toolkit for more details.

(Required by 2020) CDISC Standards    CDISC Implementation Guide

Cardio Vascular Implementation Guide       TAVR




1. Medical Device and Diagnostic Industry 101, Carey Smoak

2. CDISC for the Medical Device and Diagnostic Industry, Carey Smoak

3. Regulatory Submissions for Medical Devices and Diagnostics: The Basics, Carey Smoak

4. CDISC for the Medical Device and Diagnostic Industry: An Update, Carey Smoak

5. Mission Possible: A Proposed SDTM Domain for the Medical Device and Diagnostic Industry, Carey Smoak


6. Seven New SDTM Domains for Medical Devices, Carey Smoak, Fred Wood, Rhonda Facile, Kit Howard


7. Data Standards Will Be Required: Challenges for Medical Device Submissions, Carey Smoak, Kit Howard, Fred Wood, Rhonda Facile


8. Forging New SDTM Standards for In-Vitro Diagnostic (IVD) Devices: A Use-Case Carey Smoak, Smitha Krishnamurthy, Mansi Singh, Sy Truong


9. Route to SDTM Implementation in In-Vitro Diagnostic Industry: Simple or Twisted, Carey Smoak, Sofia Shamas, Chowdagam Chaitanya, Don Lim, Girish Rajeev

 

10.  Referencing Medical Device Data in Standard SDTM domains Timothy L Bullock,
Ramkumar Krishnamurthy


11. Adaptive Designs for Medical Device Clinical Studies, FDA Guide


12. Considerations in Conforming Data from Multiple Implantable Medical Devices to CDISC Standards Using SAS®, Julia Yang [ADTTE]


13. SAS® as a Tool to Manage Growing SDTM+ Repository for Medical Device Studies, Julia Yang


14. Silicon Valley BioTalks - CDISC for Medical Device Companies


15. Tackling Clinical Lab Data in Medical Device Environment, Juan Wu, Min Lai


16. Time to Event Analysis in the Pharmaceutical and Medical Device Industries, Helen M. Chmiel, Evan L. Ritzema


17. Mapping Unique Aspects of Implantable Medical Device Study Data to CDISC SDTM Medical Device Domains, Timothy L Bullock, Sini Nair, Ramkumar Krishnamurthy, Todd M Gross


18. A Critique of Implementing the Submission Data Tabulation Model (SDTM) for Drugs and Medical Devices, Carey Smoak


19. SDTMs in a Medical Device Trial – A First Attempt Phil Hall


20. Developing ADaM Dataset for Cardiovascular Outcome Studies, Joanne Zhou, Rakesh Kumar, David Wade, David Chen


21. A Critique of the Use of the Medical Device SDTM Domains in Therapeutic Area User Guides Carey Smoak 


22. Device Domains: Examples of their Use in Clinical Trials, Oksana Voevutska 


23. Challenges in Implementing Device Related ADaM and SDTM Standards in a Drug-Device Study, Wenying Tian, Maureen Maunsell, Karin LaPann


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