The resources below were developed by the Modernization of Statistical Analytics (MoA) Initiative in an effort to accelerate the use of novel statistical computing capabilities when engaging with Health Authorities.
THREE CORE PRINCIPLES FOR REGULATORY COMPLIANCE & IMPLEMENTATION SUCCESS
The measure of correctness of software libraries that are used to generate results from an MSA environment – it is not the programs that developers write using those software libraries.
Refers to the ability to trace inputs to outputs, with the main goal being to provide evidence to connect e-data, code, and environment to the final output that is produced.
If a statistical analysis output can be recreated from the original dataset along with the associated environment, including all artifacts and dependencies, it is reproducible. If an output is not reproducible, it is questionable whether results of the output can be trusted.
This Framework is based upon a methodology that establishes the principles of accuracy, reproducibility, and traceability for a modern analytical software environment to demonstrate that the results it generates is reliable. A set of best practices and guiding principles is also provided to support the Framework’s implementation across industry sponsors and other stakeholders. Click here to download.
Provides a visual overview of the MSA Framework including key methodologies, concepts, and impact areas for a broader understanding of the Framework paper. Click here to download.
A presentation to support the socialization and usage of the framework concepts. This deck aims to help organizations better understand and utilize the MSA Framework as they explore the use of nontraditional analytical software in clinical research. Click here to download.