Training & Education

The Mentor Spotlight is a monthly webinar series where we hear from a mentor in the Community of Practice as they share best practices and highlight exceptional processes. Sign up for this month’s webinar and view recordings of previous webinars here. 

Good Clinical Practice (GCP)  Guidelines

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

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 safety or performance of medical devices for regulatory purposes.

Tri-Council Policy Statement 2 (TCPS2)

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.

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 Regulations Division 5

Part C, Division 5 of the Food and Drug Regulations is a Health Canada required for research staff conducting a Health Canada regulated clinical drug trial.

Health Canada Investigational Testing Application (ITA)

This guidance document provides assistance to manufacturers and importers in organizing and submit- ting 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).

U.S. Food and Drug Administration (FDA)- Device

FDA’s Center for Devices and Radiological Health (CDRH) web page for multimedia industry education.

U.S. Food and Drug Administration (FDA)- Drug

Code of Federal Regulations for Investigational New Drugs (INDs), New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs) and Biologics License Applications (BLAs).

Code of Federal Regulations (CFR)- Title 21

This database includes a codification of the general and permanent rules published in the Federal Register by the Executive departments and agencies of the Federal Government. Title 21 of the CFR is reserved for rules of the Food and Drug Administration.

TransCelerate

TransCelerate creates pragmatic solutions, such as templates, guidance, model frameworks and systems, that addresses barriers and issues that are negatively impacting the ability of the biopharmaceutical industry to bring medicines to patients that need them. These solutions are developed collaboratively and can be voluntarily adopted by stakeholders in the clinical research ecosystem.

Clinical Trials Transformation Initiative (CTTI)

Tools and resources with the aim 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.

Collaborative Institutional Training Initiative (CITI) Programs

The CITI-Canada Program offers comprehensive courses on a variety of research related matters.

Complion

Complion offers a resource library for the clinical research community, including articles and training videos.

Ethics & Human Subject Protection

On-demand eLearning course provides in-depth training on the history and importance of ethical conduct in clinical trials involving human subjects. ACRP offers this training at no charge (no CE) for anyone with an an ACRP account.

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

The Good Clinical Practice (GCP) course is designed to prepare research staff in the conduct of clinical trials with human participants. The 12 modules included in the course are based on ICH GCP Principles and the Code of Federal Regulations (CFR) for clinical research trials in the U.S. The course is self-paced and takes approximately six hours to complete.

TCPS2 Training

The Panel on Research Ethics (PRE) offers online training and certification on the TCPS2.

MRCT Center Online GCP training

This is an introductory course consisting of the following 10 modules that reflects 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.

QuickSTART Budget Building Tool

CTOs QuickSTART program is aimed at improving study start-up efficiency.  This budget building tool is meant to be customized to a research department and then further customized per research protocol as needed.

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.

Patient Engagement Tools

As part of CTO’s efforts to engage patients and the public with clinical trials, we are leading and actively participating in initiatives to build resources and tools to help the community work together. Some resources and initiatives are found here.

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.

NIH Clinical Trials.gov

ClinicalTrials.gov is a database of privately and publicly funded clinical studies conducted around the world.

It starts with me

N2’s Clinical Trials Education and Awareness Committee has worked closely with patients and caregivers to create this resource for people considering being in a clincal trial.

Clinical Trials Ontario (CTO) Trial Finder

CTO’s Clinical Trials Finder is a search tool created to help people look for a clinical trial. The source of information is a clinical trials database (clinicaltrials.gov) used by clinicians, researchers and companies around the world to provide public access to information about clinical trials. The tool is available in both French and English.