Around the Data DOSE-y Doe: Using DOSExx Variables within ADaM Data Sets

About this session

Part of Session 5, Track A: Foundational Standards - Advanced Standards (Chair: Srinivasa Rao Mandava, Merck).

In the realms of pediatric, oncology, and diabetic trials, a challenge in capturing treatment and dose levels arises when protocol-planned dose levels are adjusted during the treatment period. How can data analysts choreograph the Analysis Data Model (ADaM) data sets to capture these nuanced dose levels? The treatment variables TRTxxP/N in the Subject-Level Analysis Dataset (ADSL) and their partners TRTP/N in Basic Data Structure (BDS) and Occurrence Data Structure (OCCDS) are designed to group subjects by treatments as columns in the summary tables. But we also need to preserve the dose level adjustments on a subject- and record-level basis. DOSExxP and DOSExxA are used in ADSL, while their counterparts, DOSEP and DOSEA, lead in the BDS and OCCDS data sets. Together, these harmonious variables pirouette across the ADaM data sets, capturing the very essence of the adjusted dose levels in a dance that seamlessly unfolds.

Speaker

• RW

  Richann Watson

  InkaStat Solutions

  Speaker