Summary

This article covers building the regulatory bodies manager and the regulatory requirements manager.

The Regulatory Manager allows the user to begin the regulatory tracking process in CTMS by building a repository of regulatory authorities and commonly requested components of submissions to those regulatory authorities. The Regulatory Manager is comprised of the Regulatory Requirements Manager, and the Regulatory Bodies Manager, from which this repository can be administered. Once the Regulatory Manager has been populated with Regulatory Bodies and their associated Requirement Sets, these can be quickly imported into a new or existing Study. This enterprise level Regulatory Manager is used to build out your repository of standardized requirement sets. This forms the backbone of our Regulatory Tracking features employed within active trials. Once built, much of the work involved in building out requirement sets can be reused rather than repeated.

Need more help?

Please visit the Fountayn Contact Information page.