ADaM 3.0 Update Part 3: New Content

About this session

Part of Session 3, Track A: Foundational Standards - ADaM (Chair: Harivardhan Jampala, Sumitomo Pharma).

With a quick overview of what ADaM 3.0 will contain, which is covered in detail in Part 1 of this ADaM 3.0 Update presentation series, this presentation focuses on new material included in ADaM v3.0. We will walk through new variables not previously part of any normative ADaM documents. We will describe what we have done with PARQUAL, a variable provisionally used in some CDISC example documents and mentioned in the USFDA Pilot OHOP Safety Team Standard Data Requests document. We will cover the new ADaM concept of Analysis Topic. Additionally, since new content comes with new opportunities for conformance rules, we will give a preview of what rules are being added or modified based on this new content. This is presented by two active ADaM 3.0 Consolidation sub-team members, one who is a former ADaM team lead, and the other who is the ADaM Conformance sub-team lead.

Speakers

• SM

  Sandra Minjoe

  ICON

  Speaker

• AW

  Alyssa Wittle

  Atorus Research

  Speaker