Nonclinical Topics

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Data Consistency: SEND Datasets and the Study Report: Identify and address inconsistencies between the study report and the SEND datasets. Determine which would be acceptable and which are not. Develop potential solutions for how companies go about fixing the ones that are not deemed acceptable.

Data Visualisation an an Enabler for Nonclinical Safety Signal Detection: The overall objective 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 utilize existing software visualization 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 standardized 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 will include exploration of published general information (clinical or nonclinical) about implementing code lists in define.xml and relating this to specific challenges expressed by nonclinical data stakeholders, such as: Is there a relationship to operational procedures on the data collected (i.e. glossaries)? What is the appropriate granularity? The project will include exploration for the codelist content of define.xml files associated with SEND datasets and how this is used by 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 codelist section of the definition.xml for SEND study submissions. 

Industry SEND Progress Survey: To create an electronic survey sponsored by PhUSE with up to 15 multiple choice questions with an option to provide additional free text information. Send that survey out to the PhUSE members requesting a 30 day response time. Compile the responses and distribute to PhUSE members and make the results available on the PhUSE Wiki.

Modeling Endpoints: How to Model Anti-Drug Antibody Data in Nonclinical Studies: To provide recommendations for modeling Anti-Drug Antibody utilizing SENDIG V3.0 and SENDIG V3.1 domains and variables. To create a landscape of possible solutions and provide recommendations. Consider appropriateness for visualization for ADA at high level. Investigate the current SDTM practices and recommendations.

Nonclinical Script Assessment Project: 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 Reviewers Guide: This project is to evolve the Nonclinical Study Data Reviewers Guide (SDRG), based on comments from a public PhUSE review, plus adapt to updates of the Technical Conformance Guide, from FDA. Our goal is for the NC SDRG package to be considered in FDA's Intent to Use process in 2016. We also continue 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.



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