Research Ready

Research Ready offers community driven training and educational support for research coordinators, research personnel and new investigators in Ontario. Research Ready leverages existing programs and material, including programs developed by Ontario centers, with the aim of supporting the Ontario research ecosystem. Members of the research community can contact CTO to suggest topics or speakers for our monthly webinar series, access past recordings of webinars, share stories and best practices and sign up for our community newsletter to receive regular updates.

Two researchers reviewing data at a computer

Purpose & Goals



Advisory Group

Rosemarie is a Registered Nurse with a Bachelor of Science degree in Nursing and a Masters in Health Management. She has certifications as a Clinical Research Professional with the Society of Clinical Research Associates (SoCRA) and a Certified Health Executive with the Canadian College Health Leaders.  Rosie, currently holds the position of Clinical Research Manager and Project Manager at the University Health Network, a tertiary and academic based hospital in Toronto.  Rosie specializes in Clinical Research Operations and has coordinated and managed studies in many therapeutic areas and in all phases of clinical trials. This specialty positioned her to project manage several COVID studies throughout the pandemic.  Rosie is instrumental in the startup and implementation of a decentralized study called STOPCoV and currently oversees a research team of Investigators, coordinators and analysts.

Velma Marzinotto is an independent clinical research consultant. She has over 18 years of experience as a clinical research quality auditor. Velma developed the internal research quality audit program at Unity Health Toronto – St. Michael’s Hospital and The Hospital for Sick Children (SickKids). In addition, she also facilitated clinical research by providing education to researchers. Previously, Velma worked as a clinical research nurse coordinator managing clinical trials in the use of anticoagulants in children, a hematology/oncology nurse educator and a hematology/oncology staff nurse at SickKids and a general duty RN in pediatrics at McMaster University Medical Centre. Velma obtained her BScN from McMaster University, Hamilton.

Margaret Molnar is clinical trials expert with broad drug development knowledge.She has over 15 years of experience working in the clinical research field.Margaret is currentlya Senior Clinical Operations Lead at Hoffmann La Roche with a focus on study management at a Canadian and global level across multiple therapeutic areas.Through her career she has held a variety of study and people management positions acrossthe CRO, hospital, and sponsor settings.

Emily is an experienced clinical research professional with experience at several tertiary and quaternary care academic hospitals in Toronto both in adult and pediatric settings. She completed her BSc in Integrated Science at McMaster University, followed by postgraduate education in Clinical Research at Humber College, and holds the Certified Clinical Research Professional designation from SOCRA. Currently, Emily is a Clinical Research Manager at University Health Network where she oversees a team of clinical research coordinators in the Cancer Clinical Research Unit (CCRU), spanning various solid tumour, malignant hematology, and benign hematology disease sites in both interventional clinical trials and non-interventional research studies. Previously Emily worked at SickKids in the Hematology/Oncology Clinical Trials Support Unit focusing on neuro-oncology and international investigator-initiated trials, and got her start in clinical research at Mount Sinai Hospital with both the Retroperitoneal Sarcoma and the Peritoneal Malignancy Surgical Oncology teams.

Mentor Spotlight Webinars

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References & Resources

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.

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.

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.