Summary

This article provides an overview of regulatory tracking in CTMS.

The regulatory tracking features in CTMS are utilized at a study level. The screens associated with regulatory tracking can be found beneath the Regulatory sub menu found in the study navigation tree. Once the repository of regulatory bodies and standard requirement sets have been built up in the Regulatory Manager, you can easily pull these prototyped components of regulatory submissions into any created study.

CTMS provides a manager to create and track both regulatory submissions and amendments. General information regarding submissions can be tracked on the submission form, and contained within each is a number of requirement sets. A requirement set is a highly configurable data collection interface intended to store both the documents that make up a submission, as well as any dates and other meta information that needs to be collected surrounding those documents.
By bringing the regulatory submissions process into CTMS we are better able to report on the status of the submissions process across our studies. The platform is also able to provide powerful time-saving utilities it its ability to prototype standard components of regulatory submissions, and eliminate double data entry by enabling the sharing of data between submissions.

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