N2 is excited to announce that our Quality Committee have two new tools. These are available now on the N2 website. A description of these tools are provided below.
Overview of Research QMS
This document provides an introduction to a Research Quality Management System (RQMS). It includes a description of RQMS basic components, tools and guidance documents. It also provides a brief overview of a Quality By Design approach to help researchers incorporate quality into trial design and processes.
QMS Institutional Gap Analysis Tool
This tool provides definitions of the nine (9) components of a Quality Management System, such as: Document Management System (DMS), Audit System. This is an evaluative tool to determine systems and procedures currently in place, or required, to support a clinical trial from a quality and risk standpoint.