pharmaR / risk_assessment

Risk Assessment Shiny Application

The Risk Assessment App is an interactive web application serving as a front end application for the riskmetric R package. riskmetric is a framework to quantify risk by assessing a number of metrics meant to evaluate development best practices, code documentation, community engagement, and development sustainability. The app and riskmetric aim to provide some context for validation within regulated industries.

Furthermore, the app extends the functionalities of riskmetric by allowing the reviewer to

• analyze riskmetric output without the need to code in R,
• comment on the value of individual metrics,
• provide an overall assessment on the package (i.e., low, medium, or high risk) based on the output of the evaluating metrics cohort,
• download a report with the package risk, metrics, and reviewer comments, and
• store assessments on the database for future viewing.

The app also provides user authentication. There are two roles on the app: regular user and admin. The latter can add/delete users, download an entire copy of the database, and modify the metric weights.

For further information about the app, please refer to the documentation.

Our Approach to Validation

Validation can serve as an umbrella for various terms, and admittedly, companies will diverge on what is the correct approach to validation. The validation approach we followed during the development of the app is based on the philosophy of the white paper set forth by the R Validation Hub: White Paper.

Documentation

We are currently working on improving the app and the documentation. Watch out for the dev branch!

In the meantime, please refer to the documentation here.

Contributors/Authors

We would like to thank all the contributors!

Specially, we would like to thank the following contributors/authors.

• R Validation Hub
• Marly Gotti, Biogen, Maintainer
• Aaron Clark, Biogen, Maintainer
• Robert Krajcik, Cytel, Maintainer
• Maya Gans, Cytel
• Aravind Reddy Kallem
• Fission Labs India Pvt Ltd

Note: This app was made possible thanks to the R Validation Hub, a collaboration to support the adoption of R within a biopharmaceutical regulatory setting.

License

Please see the License file that lives alongside this repo.