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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, email: workinggroups@phuse.global.

Good Transparency Practices – Project Co-Lead and Members

The project aims to define a set of best practices for data transparency and create a Good Transparency Practices guidance. The best practices will help ensure anonymised data is compliant with the legal requirements, as defined by regulators, as well as preserving as much data utility as possible. 

Treatment Emergent Survey

The PHUSE Treatment Emergent Definition project team has goals of reducing variation in treatment emergent definitions and better harmonizing industry practice. The group developed a survey to collect input on various treatment emergence scenarios and it will play a key role in meeting their objectives. The survey launched in mid-August and to date the group have had approximately 230 respondents. Unfortunately, only 1 person from a regulatory agency has participated so far. The group invite more input from our regulatory colleagues before the survey closes on the 18 February and would appreciate your help with soliciting for more participants from the FDA. 

PHUSE's BIMO project team have prepared s BIMO project team have prepared a final draft version of the BIMO Data Reviewers Guide Package.

The purpose of this is to allow up front communications to the FDA regarding sponsor’s consideration and deviations from the latest BIMO Technical Conformance Guide (TCG) and, in an effort to avoid the Information Requests that are currently issued by the agency to sponsors, to address inconsistencies between sponsor’s interpretation of BIMO TCG, format and content of Bio-research Monitoring Data Reviewers Guide. 

The team is respectfully calling for public feedback on the package which includes a BDRG template, completion guideline and examples. Before reviewing these documents, please read through the BDRG introduction and overview. Please submit any feedback to Workinggroups@phuse.global by 15 February using the BDRG review feedback tracker to log your comments.

• BDRG Template  
• BDRG Completion Guidelines  
• BDRG Example 1  
• BDRG Example 2  
• BDRG Example 3  

The Harmonization of SEND Implementation to Enable Historical Control Data Analysis team has drafted a White Paper which looks to propose harmonization for SEND Trial Summary (TS) and Trial Set (TX) parameters that are used to identify the names and locations of Test Facilities, Test Sites, and Test Subject Suppliers. 

The team is calling for public feedback on the White Paper. Please submit your feedback to workinggroups@phuse.global by 15 February.