Through the development of resources and tools, we are working to enhance clinical trials in Ontario and beyond. On this page, you’ll find a wide range of materials catered to various needs. Researchers can delve into training on CTO’s digital platforms and strategies for engaging with patients and trial participants, while the general public will find tools to locate trial opportunities and understand what to anticipate as a trial participant. Industry professionals can discover ways to facilitate connections and collaborations in Ontario’s clinical trial landscape.

Papers, Manuals & Guides

Two medical professionals, one training the other on tasks at a computer

CTO Stream is a web-based platform that allows multiple research sites participating on the same study to submit a single ethics review. To help users learn how to use the platform, we’ve developed a series of manuals and video tutorials.

Access resources for using QuickSTART, an online platform that helps clinical trials sites and industry sponsors establish standardized processes to improve efficiency and achieve a 90-day overall start-up time for clinical trials.

Researcher filling vial in a lab
A reference document to help companies new to conducting clinical trials in Ontario understand the clinical trials environment and leverage the many financial incentives and assets available in Ontario.
Two medical professionals, one training the other on tasks at a computer

The Ontario Leadership Table published a new position paper outlining their top priorities for transformative change in the clinical trials environment.

Engaging Participants & Patient Partners

Provides guidance on how to make clinical trial participants feel informed and valued.
Learn decentralized trial strategies to reduce barriers for participants and allow participants to engage in clinical trials on their own terms

Research Ready Webinars

External Resources

Good Clinical Practice (GCP)  Guidelines

The ICH efficacy guidelines concerned with the design, conduct, safety and reporting of clinical trials.

Health Canada Food and Drug Regulations – Part C, Division 5 (Drugs for Clinical Trials Involving Human Subjects)

Compliance with Part C, Division 5 regulations is required when conducting clinical trials of drugs in human subjects in Canada. 

Tri-Council Policy Statement 2 (TCPS2) 2022

The Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS or the Policy) is a joint policy of Canada’s three federal research agencies. The Agencies have therefore adopted this Policy as a benchmark for the ethical conduct of research involving humans. 

International Organization for Standardization (ISO)- 14155

This International Standard addresses good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the clinical performance or effectiveness and safety of medical. 

Health Canada Clinical Trials Application (CTA)

Provides guidance to all sponsors (e.g., industry, academic, contract research organization) seeking authorization to sell or import a drug for the purpose of a clinical trial in Canada.

Health Canada Investigational Testing Authorization (ITA)

This guidance document provides assistance to manufacturers and importers in preparing the documentation necessary to obtain an authorization for the sale and importation of a medical device under an investigational testing application (ITA) to perform a clinical trial in Canada with a pre-approved medical device Class II, III and IV (Non-IVDD).

Code of Federal Regulations (CFR) — eCFR

Code of Federal Regulations for Investigational New Drugs (INDs), New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs) and Biologics License Applications (BLAs). 21CFR Part 50 and 21CFR Part 312 regulate clinical investigations of medical products in the US.

Office of Human Research Protection (OHRP) — Regulations, Policy & Guidance

The OHRP provides leadership in the protection of the rights, welfare, and wellbeing of human subjects involved in research conducted or supported by the U.S. Department of Health and Human Services (HHS).

TransCelerate Biopharma Inc.

TransCelerate BioPharma collaborates across the global biopharmaceutical research and development community to identify, prioritize, design, and facilitate the implementation of solutions designed to drive the efficient, effective and high-quality delivery of new medicines.

Clinical Trials Transformation Initiative (CTTI)

CTTI is a public-private partnership co-founded by the U.S. FDA and Duke University. CTTI’s mission is to develop and drive adoption of practices that will increase the quality and efficiency of clinical trials.

Network of Networks (N2) Canada

The Network of Networks (N2) is a not-for-profit incorporated organization and an alliance of Canadian research networks and organizations working to enhance national clinical research capability and capacity. It provides educational resources and tools in clinical research.

Collaborative Institutional Training Initiative (CITI) Programs

The CITI-Canada Program offers comprehensive courses on a variety of research related matters and is accessible to N2 members/organizations.

Clinical Trials Network training (National Institute on Drug Abuse-NIDA)

The Good Clinical Practice (GCP) course is designed to prepare research staff for the conduct of clinical trials with human participants. The 12 modules included in the course are based on ICH GCP Principles, confidentiality and protection of study participants enrolled in substance use trials, and the Code of Federal Regulations (CFR) for clinical research trials in the U.S. 

TCPS 2: CORE-2022 Training

The online tutorial CORE-2022 (Course on Research Ethics) is an introduction to the Tri-Council Policy Statement (TCPS 2) for the research community. It focuses on the TCPS 2 ethics guidance that is applicable to all research involving human participants. 

Multi-Regional Clinical Trials Centre (MRCT Center) Online GCP training

This is an introductory course consisting of 10 modules reflecting the ICH Guideline E6(R2): Guideline for Good Clinical Practice. The content is particularly directed at governmental regulatory reviewers and inspectors and is also applicable to other stakeholders including investigators, study teams, ethics committee members, research organizations and sponsors.

U.S. Food & Drug Administration (FDA) — Centre for Devices & Radiological Health

Link to CDRH Learn, the FDA’s Center for Devices and Radiological Health multi-media educational resource for industry. This page links to information in various formats that address medical device and radiation emitting product laws, regulations, guidance and policies.

National Institutes of Health (NIH) Clinical Research Toolbox

The NCCIH Clinical Research Toolbox provides a Web-based information repository for investigators and staff involved in NCCIH-funded clinical research. The Toolbox contains templates, sample forms, and information materials to assist clinical investigators in the development and conduct of high-quality clinical research studies. 

UHN CAPA Report Template

Template shared by UHN’s Cancer Clinical Research Unit to document Corrective Action and Preventive Action (CAPA) findings during an inspection.

CHEO Research Institute Pre-Inspection Readiness Review Checklist

Template shared by CHEO Research Institute to aid in preparing for an inspection. This detailed checklist is broken down into the different components that may be inspected.

Lawson Research Institute Prep Visit – Lead Site Preparation Checklist

Template shared by Lawson Research Institute to aid in preparing for an inspection. This detailed checklist is broken down into the different lead site components that may be inspected.

UHN Daily Audit Inspection Summary Template

This template shared by UHN’s Cancer Clinical Research Unit is used to document daily inspection summaries including any applicable action items and requested documents. It may provide additional support during remote inspections to ensure the whole team is regularly updated.

Health Canada Forms: Applications & Submissions for Drug Products

Links to electronic versions of application and submission forms for drug products.

Health Canada Forms: Medical Device Application & Report Forms

Links to electronic versions of application and submission forms for medical devices.

Health Canada Forms: Natural Health Products Clinical Trials Forms

Links to electronic versions of application and submission forms for medical devices.

Patients & General Public

Basic information that was co-created with patient partners about finding trials and the clinical trial process

A search tool created with and by patient partners to help people look for a clinical trial

A database of privately and publicly funded clinical studies conducted around the world.

A resource for people considering being in a clinical trial, developed by the Network of Network’s (N2’s) Clinical Trials Education and Awareness Committee.