| Working Groups Hot Topics |
PHUSE collaborations are organised into a number of specialist Working Groups, each with a broad topic area. The Working Groups have specific projects designed to achieve a set of particular objectives. |
This page will highlight the latest news and information from our projects. Participation is open to anyone who wants to contribute and if you would like to get involved, please |
email workinggroups@phuse.global. |
After the success of their last two events, the Emerging Trends & Technologies Working Group is back to kickstart the new year with yet another PHUSE Community Forum! Submitting Real-world Data takes place 18 January. Register here and get 2023 off to a great start with a free, PHUSE virtual event.
Call for Questions!
The SDTM ADaM Implementation FAQ project is currently calling for industry questions. The purpose of this project is to collect FAQ's and develop and review a response in order to provide implementation/strategy information. The team sometimes collaborate with FDA and CDISC. The Q&A is then published on the PHUSE Advance Hub under one of the following categories:
If you would like to submit a question to the SDTM FAQ team, please contact workinggroups@phuse.global.
Recently Published Deliverables
Visit the PHUSE website to view the extensive list of all published deliverables.
The Educate the General Population project, part of the Data Transparency Working Group, aim to create engaging content that can be understood and used by the general population (any member of the public regardless of their sector or profession). The team have recently published two, out of a series of six, videos on data privacy and data sharing. The purpose of these videos is to answer frequently asked questions which will enable viewers to become more informed, thus helping to have a positive impact on their families and the wider community. The two videos are an Introduction and Importance of Clinical Trials. Please submit any feedback, to workinggroups@phuse.global.
If you would like to become a valued member of PHUSE and volunteer for one or multiple projects, please email: workinggroups@phuse.global.
Management of ODS Regulatory Referenced Deliverables: Do you have experience in creating any of the four regulatory referenced deliverables (cSDRG, ADRG, BDRG, SDSP)? The Optimizing the Use of Data Standards Working Group is looking for you to be a part of a new project to ensure these deliverables are kept up-to-date with regulatory guidance's. You will work with the ODS Working Group leads to coordinate updates as needed. To apply for this project, click here to submit an application form.
An exciting opportunity has arisen within the PHUSE Nonclinical Scripts project to collaborate with BioClelerate, the FDA and CDER for assistance with implementing the sendigR open-source package at your company. Collaborative team meetings will take place Fridays 8-9am EDT. Ideally, volunteers will have some programming experience (ie, python, unix/R) and some knowledge of internal SEND data storage. Click here for more information on the sendigR package and the benefits of working collaboratively. If you are interested in getting involved, please contact workinggroups@phuse.global.
| PHUSE/FDA CSS 2024 | ||||||
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Registration for the PHUSE/FDA CSS 2024 is open! Come and be a part of the PHUSE/FDA Computational Science Symposium 2024 (CSS) taking place 3–5 June in Silver Spring, MD. Share your insights, discoveries and solutions with the PHUSE Community, who are eager to learn and collaborate.
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| Calling For Feedback |
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The Good Transparency Practices project within the Data Transparency Working Group, is now calling for feedback! This White Paper aims to define a set of best practices for data transparency and create a Good Transparency Practices guidance. The best practices will aim to ensure anonymised data is compliant with the legal requirements as defined by Regulators, as well as preserves as much data utility as possible. Please send in your comments to workinggroups@phuse.global by 3 May. |
| New Deliverables |
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The Best Data Practices for Rare Disease Patient Foundations and Researchers within the Real World Evidence Working Group, has published a new deliverable in the form of a poster. The poster provides an overview of Ensuring Registry Data Relevance and Reliability for Regulatory Use. The PHUSE data standards community, which is comprised of leaders and experts responsible for the governance and implementation of data standards across the biopharmaceutical industry, have authored and new White Paper. The Data Standards White Paper highlights current challenges in data standardisation across the biopharma industry and identify opportunities where we can work together to tackle them. The SDTM ADaM Implementation FAQ within Optimizing the Use of Data Standards Working Group have published a new FAQ! The question they have answered is 'Naming Convention for Split RS Domain', you can view this question and the teams response viaValidation/Conformance Rules page. You can see all the FAQ this project has answered so far via here. Do you have a SDTM ADaM question? You can send your questions to the team by emailing workinggroups@phuse.global. |
Volunteer Opportunities | |
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The Data Visualisation & Open Source Technology Working Group has a new project, Demonstrating Real-World Impact of Modernization of Statistical Analytics (MSA) Framework.This project aims to extend the MSA framework by creating a reference architecture that takes into account real-world scenarios and design solutions to remediate them, ultimately providing a practical guide to building an end-to-end validated environment for regulated work. Companies seeking to build an open-source programming environment for regulatory reporting can leverage the MSA framework for guidance. However, since the framework is designed to be both flexible and extensible, implementing it may prove challenging for companies, resulting in situations where risks are not sufficiently mitigated. While the original MSA paper provided conceptual guidance, the PHUSE handover of the project will seek to provide an overview of practical implementations of the framework being applied. This project is calling for volunteers, to join contact workinggroups@phuse.global by 26 April. The Safety Analytics Working Group is looking for a new Working Group Lead to join their team. This Working Group is a cross-disciplinary collaboration working to improve the content and implementation of clinical trial safety analyses for medical research, leading to better data interpretations and increased efficiency in the clinical drug development and review processes. Click here to see a list of current projects within this Working Group. Learn more about the roles and the responsibilities of a Working Group Lead and apply by emailing workinggroups@phuse.global. Closing date 26 April. Multiple projects within Working Groups are open to join. PHUSE welcomes new members who can apply their knowledge to bring fresh ideas and contribute to the ongoing work of PHUSE projects. For more information, click here, read the Welcome Pack or email workinggroups@phuse.global. |
PHUSE Communications | |
Working Groups Report: Includes project updates, recent and upcoming deliverables and future plans for each Working Group. | |
Monthly Mailings: The monthly newsletter. Here you will find a full update from each month of the year, easily accessible and divided into key areas of PHUSE. | |
PHUSE Blogs: Fancy a quick read? A blog is a perfect way to catch up on all things Working Groups. Get the lowdown on the latest events from across the globe and stay updated on industry topics brought to you by industry professionals. |
| New Project Idea? |
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Initiate and lead a new project under the PHUSE Working Groups umbrella. The new project must address problems of significant relevance to computational science related to drug, |
biological and device development and must meet all of the guidelines for projects within the collaboration, including the following mandatory requirements:
New projects can be submitted anytime during the year, click here to submit |
Working Groups Latest Report Q3/4 2022: The report includes project updates, recent and upcoming deliverables and the future plans for each Working Group.
Monthly Mailings: Our monthly newsletter. Here you will find a full update from each month of the year, easily accessible and divided into key areas of PHUSE.
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