Welcome to the PHUSE Wiki
The PHUSE Wiki is an PHUSE/FDA/Industry collaboration to provide a medium to share information specifically relating to clinical trial informatics.
Currently 6,861 users are helping to Connect, Share, Advance clinical informatics.
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Working Groups News
Deliverables out for public comment:
The Analyses and Displays project has produced a White Paper and is currently seeking public feedback. The closing date is 10th July.
The White Paper is intended to provide recommendations on analyses and displays to sponsors who are planning analyses for Safety Topics of Interest for Phase 2-4 Clinical Trials and Integrated Summary documents (or other documents in which analyses of safety are of interest).
General Output Tips and Considerations project has produced a White Paper and is currently seeking public feedback. The closing date is 10th July.
This White Paper provides general advice on the display of data in tabular form. The intent is educational and not prescriptive as an aid to considering how to present data in tables.
Final Published Deliverables
The Data De-Identification Toolkit project has published a White Paper which draws a detailed dataset(s) anonymisation process map. The paper identifies challenges and potential pitfalls of the process, suggest best practices and offers automation ideas and examples. Click here to download.
The Global View of the Clinical Transparency Landscape Best Practices Guide builds upon the “Clinical Trial Transparency and Disclosure: A Global View” White Paper listed below. In this Best Practices Guide, subject matter experts share recommendations with the aim of fostering a holistic approach to clinical data transparency and disclosure that provides accurate and complete information across multiple disclosure platforms.
The Clinical Trial Transparency and Disclosure: A Global View White Paper was developed by industry experts with the goal of highlighting the evolving global landscape of clinical trial transparency and disclosure, with special focus on individual study and submission-related requirements. Click here to download the paper.
Calling for Volunteers
Harmonization of SEND Implementation to Enable Historical Control Data Analysis
The scope of this project is to evaluate and recommend approaches for SEND harmonization to better enable analysis of historical control data. SEND harmonization strategies include creation of new variables, controlled terminology, preferred terms, reference lists and/or analysis strategies (scripts) to enable cross study analysis. Developing a solution framework for variability that includes representation of stakeholders involved in the creation and use of SEND datasets will enable more efficient routine analysis of warehoused SEND data. Harmonizing the implementation and use of SEND is expected to benefit all involved stakeholders and to ultimately contribute to the goal of increased productivity in nonclinical research.
contact email@example.com to get involved.
Last revision by WendyDobson, 07/3/2020