Genomic data collected as part of clinical research supports both development of quality patient care and improvements in patient outcomes. A new domain in the Study Data Tabulation Model Implementation Guide (SDTMIG) v3.4 for representation of genomic data, Genomics Findings (GF), has been developed based on current clinical research use cases and refinement of previous standards.
The GF domain supersedes the domain Pharmacogenomics/Genetics Findings (PF), which was deprecated as part of SDTMIG-Pharmacogenomics/Genetics (PGx) v1.0. Supporting Controlled terminology, including a Codetable Mapping File, and other materials to support stakeholder implementation have also been developed.
Join us for a webinar where we will discuss:
- A brief history of CDISC standards for genomic data to-date
- A walkthrough of the domain GF, including relationship to superseded domain PF
- A summary of planned future directions for refinements to GF and development of materials to support stakeholder implementation over time
- How you can be involved in continuous improvement of these standards!
- Glenn Barnes, Senior Consultant for Clinical Specimen and Data Management, CDISC
- Christine Connolly, Senior Project Manager, Standards Development, CDISC
- Dr. Erin Muhlbradt, Clinical/Biomedical Information Specialist, Enterprise Vocabulary Services, National Cancer Institute
- Jon Neville, Senior Standards Developer, CDISC