N2 Stakeholder Group

The Health Canada Guidance Document: Part C, Division 5 of the Food and Drug Regulations “Drugs for Clinical Trials Involving Human Subjects” (GUI-0100) has been released and can be found here: https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-clinical-practices/guidance-documents/guidance-drugs-clinical-trials-human-subjects-gui-0100.html

N2 Quality Committee Tools

Cannabis Tools

The “Sources-Cannabis” document lists some useful reference documents when considering to conduct a Cannabis research study.  The “Cannabis Application Checklist” documents all the steps necessary when applying to an individual cannabis licence for research. Please ensure to always use this checklist alongside with the latest version of Health Canada Cannabis Licensing application guide for research.  The “Monitoring/Auditing Checklist” is a tool which can be used when auditing or monitoring a cannabis study to ensure all details related to the cannabis licence are in order.  The “Roles and Responsibilities Guidance” assists those who require a Cannabis License for Research for an individual licence in order to understand the different responsibilities associated with different roles when filing an individual cannabis licence for research.

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.

Risk Based Assessment Tools
There are two sets of risk management tools: 1) Study Level – for specific studies, and 2) Institutional Level – for across a set of studies on an institutional level. These tools are designed to assist an institution in the risk assessment, risk evaluation, and risk control processes within the overall research risk management framework. They allow for risk scoring and also contain a comprehensive risk library. Both tools provide guidance on establishing risk tolerances and risk controls.

Monitoring Plan Tools:
Guidance for Developing Monitoring Plans is a guidance document for Sponsor/Sponsor-Investigators. It outlines all aspects required for a risk-based monitoring plan for a clinical trial. It includes examples of template text as well as a Monitoring Checklist Template. The Monitoring Risk Level Tool can be used to assist Sponsor-Investigators in determining the extent of site monitoring required for their trial.

The N2 Metrics Committee is pleased to announce the launch of the collaborative education initiative between N2 and the Metrics Champion Consortium (MCC).  More information can be found here.

The N2 strategic plan can be found here and the outline here

The PTC toolkit can be accessed here.

The N2 SOPs are available to its members: Here is a direct link to the SOP information.

If you have any questions, please contact Shelley King at shelley.king@n2canada.ca.