| 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. |
Data Transparency Winter Event – 7-9 February
This year, the DT Winter Event will run across three days from 15:00 to 17:30 (GMT) and will feature live presentations, followed by a joint panel discussion/Q&A session. Find out whats in store by viewing the proposed agenda and click here to register!
Submitting Real-world Data – 18 January
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! Register here and get 2023 off to a great start with a free, PHUSE virtual event!
Reimagining a Safety Submission – Aggregate Safety Assessment Planning – 16 February
The Safety Analytics Working Group will present their first ever Community Forum on 16 February 2023! Click here to register!
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, sometimes collaborating 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 SDTM ADaM Implementation FAQ project, part of the Optimizing the Use of Data Standards Working Group, have recently published their latest response to a question they received under SDTM/ADaM IG Nuances. The question is based on Historical Data Consideration in the SV Domain (under SDTMIG v3.4).
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.
The Nonclinical Topics Working Group is on the lookout for members to join the Conformance with the Tumor.xpt Specification project. The aim of this project is to create a non-exhaustive first set of technical conformance rules with the tumor.xpt specification. This project will provide the first set of validator rules to be implemented by tools already used by the industry for verification of SEND datasets, thus removing part of the current manual burden of reviewing this file.
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.
| Open Source – Regulatory Acceptance of Open-Source Submissions |
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Registration for the Open Source Open Forum is open! The Open Source Technology in Clinical Data Analysis (OSTCDA) project is hosting their fourth Open Forum: Regulatory Acceptance of Open-Source Submissions, they will be addressing the following questions:
Come and be a part of our next virtual Open Forum on 12 July at 15:00(BST) 10:00(EDT). |
The Dataset-JSON as Alternative Transport Format for Regulatory Submissions project within the Optimizing the Use of Data Standards Working Group, has published a new white paper. A pilot was executed to test the feasibility of using Dataset-JSON as a transport format for study data submitted with regulatory applications. The goal was to demonstrate that Dataset-JSON can serve as a transport file for study data without loss of data and no significant impact to business operations. CDISC Dataset-JSON is a modern dataset format designed for data exchange. Many software applications already import and export JSON and in the longer term more significant benefits will emerge as the constraints imposed by XPT are removed. Overall, the findings were consistent across industry and the FDA supporting the use of Dataset-JSON as an alternative transport format for XPT v5. There were several key findings from the pilot and the solutions to these will be implemented in Dataset-JSON v1.1 (due end of 2024). PHUSE and CDISC will continue to collaborate with the FDA/PMDA to discuss next steps for regulatory support. FDA/CDER/CBER testing strongly suggests that analytical tools used for regulatory review are updated to take advantage of the metadata and flexibility provided by the Dataset-JSON format. The SEND Industry Feedback Surveyproject within the Nonclinical Topics Working Group, has published the 2024 SEND Survey Results. The survey was presented at the PHUSE/FDA Computational Science Symposium (CSS) 2024 and covered topics such as Manual Edits, Implementing SEND, Harmonisation and Next Steps. The Adverse Event Collection Recommendations project within the Safety Analytics Working Group, has published a new white paper The Adverse Event Collection Recommendations. This white paper provides recommendations for adverse event (AE) collection and associated instructions for Phase II to III clinical trials, building on standardisation efforts by Clinical Data Interchange Standards Consortium (CDISC) and PHUSE. The primary intent is to reduce the variation in AE collection and instructions to improve the site experience and the quality of the data. The Quality and Reusability of Real World Data project within the Real World Evidence Working Group, has published two new Blogs! The 'Understanding the Data Quality Issues in Real-World Data Through Real-World Examples', blog takes a closer look at the experiences shared within the dedicated Working Group in exploring the types of data quality hurdles encountered when using Real-World Data (RWD).The 'Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products' blog explores the use of Real-World Evidence (RWE) as a powerful tool for informing regulatory decisions and advancing medical innovation. The Educate the General Population on Data Privacy and Data Sharing project, within the Data Transparency Working Group has published video 2 of their series. The 'What Will I Receive and When Will I Receive It?’ The video covers topics such as the concept of consent to participate in a clinical trial, an overview of trial design and treatment procedures to develop a strong foundational understanding of clinical trials. To view the full series of videos created by this team, visit the PHUSE website. |
The Enhanced Risk-based Quality Management (RBQM) Approaches for First-in-Human and/or Small Clinical Trials, a new project within the Risk Based Quality ManagementWorking Group, is now calling for volunteers. This project aims to to discuss and focus on a robust strategy/process and best practices for:
If you would like to volunteer or learn more about this project, email workinggroups@phuse.global. Closing date: 5 July 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. |
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. |
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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