PhUSE Working Groups News
The PhUSE Working groups which are led by volunteers from major stakeholders have been developing innovative solutions that address unmet computational science needs. Here we will look to share the latest information around the PhUSE working groups, from workshops to white papers, projects news and industry views.
The Standard Analyses and Code Sharing Working Group has two new projects calling for volunteers.
The Best Practices for Quality Control and Validation project is looking to produce a paper which will provide an in-depth review of best practices for robust quality control. The scope of the paper will be quality control of analysis programming of clinical data in health and life sciences organisations. It is applicable to the organisations who produce analyses of clinical data, including Contract Research Organisations.
The GPP in Macro Development project is aiming to create guideline/White Paper for creating well structured and precisely document macro code that will be easy to read and maintain over time. The paper will primarily describe, coding style of Macro, best practices while writing Macro, refactoring in Macro and a structured documentation of Macro.
Our Data Standards for Non-Interventional Studies project are seeking your input on the challenges you face during creation of the analysis datasets and handling of the data for the observational studies. We would be grateful if you could take the time to answer this two question survey. Link to Survey
A NEW Nonclinical project has just been approved and the leads are looking for volunteers to join the project. Understanding RDF Linked Data for Potential Nonclinical Use are looking to to bring together deep knowledge of SEND and RDF/linked data and broaden the base of people in the SEND community with understanding the concept of RDF/linked data to facilitate a qualified discussion.
The Industry Experiences Submitting Standardised Study Data to Regulatory Authorities project has launched a 'Discussion Forum' and is seeking your input. The scope of this project is to share submission experiences including, but not limited to submission planning, interactions with the regulators, test submissions, regulator feedback etc. Additionally, this project will explore the development of best practices for biometrics departments to engage with regulators. The project will examine different communication use cases and make recommendations as to ensure effective exchange of information.
If you would like the team to address a question you may have, please post it here.
During EU Connect in Frankfurt Chris Price will be facilitating a working group discussion club. The session will look to bring together industry colleagues and regulatory stakeholders to learn what has been successful in various collaborations, brainstorm the next generation of challenges and innovations to address, and discuss areas to be explored across regulatory agencies to minimise impact on sponsors. Registration for this hands-on work shop will commence in September.