Nonclinical Topics – Project Volunteer Board
Welcome! |
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Interested in joining one of the Nonclinical Topics Working Group Projects? The projects below welcome new volunteers. |
Project Scope: A computational pipeline to build models to predict target organs of toxicity from SEND datasets has been developed and published on GitHub under PHUSE. Project team members will evaluate the feasibility and performance of this pipeline when run on data from within their organisations. The pipeline will be updated to improve compatibility with different database systems, and efforts will be made to improve its performance across disparate data sources. Additional study interpretations – e.g. adversity of findings, NOAEL determination, clinical translatability, structure activity relationship – will be explored for development of predictive models. Successful modeling approaches will be published in peer-reviewed scientific journal articles. | Regular Project Meeting Day/Time:
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Project Scope: 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. Preparation of a Study Data Reviewer’s Guide (SDRG) is recommended as an integral part of a CDISC standards-compliant study data submission. The challenge is to operationalise this new documentation requirement efficiently and effectively. Challenges we seek to answer with this project:
Things we expect to learn along the way:
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Project Scope: Execute an annual survey process to objectively collect data that enables detection of impactful issues and trends (both good and bad) that can be acted upon by the PHUSE community The survey will:
Results of the survey will be presented at the PHUSE/FDA CSS. | Regular Project Meeting Day/Time:
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Project Scope: The 4-day SEND Coding Bootcamp aims to help those working with SEND datasets become more productive by teaching basic coding and plotting skills. Over the course of a series of separate hands-on coding sessions, participants will learn the basics of programming and plotting using the R programming language. The course will be oriented around SEND datasets and will include reading, writing, plotting, and manipulating SEND datasets stored in .xptformat. Basic knowledge of the SEND standard is expected. No previous knowledge about programming or the R programming language is needed. | Regular Project Meeting Day/Time:
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Project Scope: This project will leverage the deep SEND knowledge and experience of the PHUSE Nonclinical Topics Working Group by initially focusing on the development of best practices with respect to population of SEND datasets with data from virtual control animals. As the relative importance of various study design elements to the selection of appropriately matched virtual control animals is being actively investigated and publicised by other related efforts, e.g. the influence of anaesthesia protocols on electrolyte levels in rats (Gurjanov et al., 2023), best practices will also be developed to ensure that these elements will be appropriately and consistently represented in SEND datasets. Recommendations to CDISC will be drafted and communicated if it becomes evident that the SEND data standard will need to be modified in order for this data to be appropriately represented. Initially, the project scope will be restricted to include only study types that have been clearly modelled in SEND for long enough that data availability will not be a limiting factor in the development and evaluation of best practices, but thought will be given to best practice and data standard development opportunities to support the implementation of virtual control groups in study designs that have yet to be clearly modelled in SEND. As there are several ongoing collaborative projects attempting to develop and evaluate selection procedures and the necessary database infrastructure required to implement these procedures, this project will leverage the Nonclinical Scripts project within the Nonclinical Topics Working Group and provide an open venue for the socialisation and hosting of open-source software solutions related to selection procedures and database infrastructure. | Regular Project Meeting Day/Time:
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