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Welcome to the phuse-scripts repository. This site hosts standard scripts for data transformations and analyses across and/or within a therapeutic area and exploratory analysis. Our goal is to standardize analyses across the industry, but also include examples of what can be done with a standardized data set. We aim to establish this repository as the place to collaborate and share between industry and regulators.
WE use an MIT license and contributors agree to the User Agreement.
Here are the links to the working group at FDA/PhUSE:
This site provides a collaborative development environment for scripts for analysis and programming of clinical trials data. It was started by members of the Phuse/FDA Working Group 5. For more about this group see working group home page.
The two main projects within this working group are:
- Analysis and Display White Papers - Establish the standard analyses.
- Repository Content and Delivery - Deliver SAS and R scripts to produce the White Paper Analyses.
PhUSE publish Final White Papers on their web site.
The working group publish scripts on this GitHub site. Our 2016 goal is to publish R and SAS scripts that unlock the standard analyses that the White Paper on Central Tendency (WPCT) specifies.
While work continues on our github folder structure, the Repository Content team is working within the whitepapers subfolder. The general structure:
- Guidance for WPCT Script Users and Contributors
- specifications - General formatting conventions, as well as detailed specifications for each Central Tendancy display.
- WPCT - Standard scripts for WPCT data displays, in SAS and R. Example outputs are in language-specific subfolders.
- utilities - SAS macros that the standard scripts use for basic (generic) discovery and manipulation tasks, which should otherwise not cause distraction from the analyses that the standard scripts conduct.
- qualification - Test plans & test scripts for the standard scripts and the components that they use. Results and artifacts of testing are in language-specific subfolders.
Note: Code on this site is by definition 'under development'.