Data Consistency: SEND Datasets and the Study Report

This project identifies and addresses inconsistencies between the study report and the SEND datasets, with the aim of determining which are acceptable and which are not. The project seeks to develop potential solutions for companies to fix those that are not deemed acceptable.

Data Visualisation as an Enabler for Nonclinical Safety Signal Detection 

The overall objective of this project is to explore how data visualisation can be used as a means for enabling safety signal detection within the scope of nonclinical data. To augment this, algorithms for assisting in the identification of safety signals will be identified in the literature (and from the public domain) and considered for investigation as case examples using suitable data, such as may be available from research databases. The intent is for the project to utilise existing software visualisation tools (including HistoGraphic, which was developed in the team’s preceding project) to demonstrate potential safety signal detection using the identified algorithms or visual cues. The project will not expand into the development and/or evaluation of visualisation software. A key project deliverable will be to reinforce the importance of promoting standardised nonclinical safety data in SEND format (e.g. LB, MI & MA domain data) as a signal alert enabler. 

Demystifying Define-XML Codelist Handling for Nonclinical Studies 

The goal of this project is to provide recommendations for specific problems/questions encountered when fulfilling the Define-XML codelist section for a nonclinical study. The scope includes exploration of published general information (clinical or nonclinical) about implementing codelists in Define-XML and relating this to specific challenges expressed by nonclinical data stakeholders, such as whether there is a relationship to operational procedures on the data collected (i.e. glossaries) and what is the appropriate granularity. The project includes exploration for the codelist content of Define-XML files associated with SEND datasets and how this is used by the FDA as a consumer of the Define-XML file. The result of this project is expected to be recommendations to the public on best practices for fulfilling the codelist section of the Define-XML for SEND study submissions. 

Industry SEND Progress Survey 

This project creates an electronic survey sponsored by PhUSE, with up to 15 multiple choice questions and an option to provide additional free text information. The survey is sent out to PhUSE members, requesting a 30-day response time, then the responses are compiled and distributed to PhUSE members and the results made available on the PhUSE Wiki.

Modeling Endpoints: How to Model Anti-Drug Antibody Data in Nonclinical Studies

The goal of this project is to provide recommendations for modeling anti-drug antibody data utilising SENDIG v3.0 and SENDIG v3.1 domains and variables; to create a landscape of possible solutions and provide recommendations; to consider appropriateness for visualisation for ADA at a high level; and to investigate the current SDTM practices and recommendations.

Nonclinical Script Assessment 

Analysis scripts for SEND data would be valuable tools. Can existing clinical scripts be used to help develop nonclinical scripts? What is the best process for prioritising, developing and releasing analysis scripts for SEND data?

Nonclinical Study Data Reviewer's Guide

This project is to evolve the Nonclinical Study Data Reviewer's Guide (nSDRG), based on comments from a public PhUSE review, plus to adapt it to updates of the FDA Technical Conformance Guide. The project continues to check and align with the SDRG template and guide developed by the Optimizing the Use of Data Standards Working Group for clinical studies.

SEND Implementation User Group 

New users implementing SEND start out with only the implementation guide as a resource. Having additional places to turn to for assistance (e.g. forums, the Wiki, FAQ and the PhUSE website) substantially helps new users navigate the pitfalls of SEND implementation, offering them the opportunity to ask questions, receive answers and to discuss and learn more about common implementation issues.