DateOctober 23-24, 2024 LocationScottsdale, AZ

{sdtm.oak} – SDTM Programming in R V0.1 Release

Oct 24, Time: 15:30 – 16:00

Presented by:
Shiyu Chen
Data Solutions Engineer

{sdtm.oak} is an Electronic Data Capture system (EDC) and Data Standard agnostic solution that enables the pharmaceutical programming community to develop Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM) datasets in R. The reusable algorithms concept in ‘sdtm.oak’ provides a framework for modular programming and can potentially automate the conversion of raw clinical data to SDTM through standardized SDTM specifications. SDTM is one of the required standards for data submission to the Food and Drug Administration (FDA) in the United States and the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. SDTM standards are implemented following the SDTM Implementation Guide as defined by CDISC. This release allows the community to do modular programming of SDTM in R and can create most of the SDTM domains with a few exceptions. In future releases, we’ll focus on automating SDTM based on the standard spec/algorithms.

Admiral: An Open-Source R Package for Creating ADaM Datasets with Modularized Functions in a Readable and Easily-Constructable Manner

Oct 24, 16:00-16:30

Presented by:
Zelos Zhu
Data Solutions Engineer

Admiral is an R package designed to streamline the creation of Analysis Data Model (ADaM) datasets in clinical trials. It provides a modular toolbox of individual R functions that enable statistical programmers to build ADaM datasets efficiently. This open-source package fosters collaboration and industry-wide contributions, encouraging a consistent and reusable approach to ADaM development.
Admiral emerged to address diverse data analysis challenges across companies and therapeutic areas. By advocating an open-source framework, Admiral promotes shared solutions and a standardized ADaM approach. R was chosen for its open-source nature, popularity among statisticians, and strong data science community support. Regulatory acceptance of R-based submissions further underscores its reliability.
Admiral provides example scripts and templates for specific ADaM structures like ADSL, BDS, and OCCDS, along with thorough documentation and unit tests. The package reached version 1.0.0 by early 2024, reflecting its stability. Ongoing maintenance and documentation improvements aim to enhance user experience and package compatibility.

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