Biospecimens Team Launches, Seeks Additional Volunteers
CDISC has kicked-off a new SDS sub-team called the Biospecimens Team led by volunteers Christine Connolly and Oliver Karch of Merck. The team is responsible for futher exploring domains Biospecimen Events (BE), Biospecimen Findings (BS), and Related Specimens (RELSPEC) provisionally published in the Study Data Tabulation Model Implementation Guide for Pharmacogenomics and Pharmacogenetics (SDTMIG-PGx). These domains are used to record events, attributes, and relationships between specimens. If appropriate this team may work to further develop these domains for formal publication in the SDTMIG and/or other CDISC standards.
The CDISC Biospecimen Team is looking for volunteers to evaluate and potentially build upon current SDTM standards for sample collection, handling, and derivation. Use cases for discussion include submission of data to regulatory authorities and broader industry applications, such as molecular characteristics, pre-analytics, quality, tracking and storage of collected and subsequent derived samples, which may not be present in regulatory submissions.