PhUSE Archived Projects

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Data Validation and Quality Assessment

Standardizing data within the Inspection Site Selection Process (Re-launched in the
Optimizing the Use of Data Standards Working Group)

Challenges of Integrating and Converting Data across Studies


Pooling WHO Drug B3 Format - The FDA Data Standards Catalog requires the use of WHODrug dictionary codes for coded medications in March 2018. The WHODrug B3 format is different than the previous formats. Codes should include the drug product trade name (where available), the active ingredient(s) and the Anatomical Therapeutic Chemical (ATC) Class. This project team will create a white paper outlining best practices for creating an integrated database with medication data collected in different formats (B3 format and whatever format was applied previously).

Standards Implementation Issues with the CDISC Data Models

Development of Standard Scripts for Analysis and Programming

Non-Clinical Road-map and Impacts on Implementation

Linked Data & Graph Databases

Alternative Transport for the Next Generation

Application of SEND Data for Analysis

Investigating Endpoint Modeling - Biomarkers ADA data and Immunophenotyping

Test Submission Forum Group

Evaluation of Alternative Transport Formats

Statistical Computing Environment

Study Data Standardization Plan (SDSP)

Standardizing data within the Inspection Site Selection Process