CLINICAL TRIALS TRAINING PROGRAMS
Discover clinical trial training programs for all levels and all streams
STREAM 1-GPT
For Graduate & Postdoctoral Trainees (GPT) in the health sciences
STREAM 2-CRP
For Clinical Research Professionals (CRP)
STREAM 3-TRIALISTS
For Clinical Researchers
STREAM 4-PARTNERS
For Community Partners
CANTRAIN is a unique national educational initiative aimed at developing clinical trial competency in people designing, leading, working or participating in clinical trial research in both academic and private sector settings. Our clinical research competencies are inspired by those of the Multiregional Clinical Trials Joint Task Force (JTF) for Clinical Trial Competency framework. Professional competence is a unique combination of knowledge, skill and attitude and is demonstrated by the ability to perform a complex task with fidelity in a wide variety of contexts. In the CANTRAIN model, e-learning modules – providing topical content – are enhanced by integrated engagement or experiential activities and access to expert mentorship. The combination of information, engagement and personal guidance is the best way to develop professional competence in learners. CANTRAIN modules are tailored, sequenced, and assembled into programs that build professional competence in learners with different profiles (students, clinical research professionals and trialists) and levels of experience. By doing this, the learners are best able to contribute to clinical trials’ innovation, advancement and growth benefiting the health care system, with an inclusive engagement of the community at-large.Postgraduate Master’s Students
Doctoral Students
Postdoctoral Fellows
Postdoctoral Researchers
in health sciencesRegistered Nurse
Nurse Practitioner
Clinical Research Assistant
Clinical Research Associate
Clinical Research Coordinator
Clinical Research Manager
Quality Assurance and Regulatory Affairs (QARA)
Medical/Health Sciences’ GraduatesResidents/Fellows
Clinicians
Family Physicians
Specialists
ScientistsGeneral Public
Patients
Public/Private Organizations
Health Charities
Families
Policy-Makers
Journalists
Social Media Influencers/Reporters
Toward Equity, Diversity and Inclusion of Black, Indigenous, and People of Color, Immigrants, Refugees, minoritized, underserved and underrepresented groups
WELCOMING ORIENTATION LEVEL
Introduction – This content introduces the CANTRAIN educational program and the interactive elements of the platform. Information about the nature, importance and impact of clinical research, and clinical trials more specifically, is provided. You’ll also learn how CANTRAIN can help prepare you to join the clinical research workforce or further develop your existing skills in clinical trial research.
Navigate the CANTRAIN LMS – The CANTRAIN training platform features the Blackboard Learning Management System by Anthology. In this section, you’ll learn how to navigate the CANTRAIN LMS to take full advantage of the sophisticated e-learning tools the system offers.
Navigating CANTRAIN Learning Management System
REGULATORY COMPLIANCE LEVEL
Regulatory training courses- Research to create new medical interventions for humans is subject to governmental or regulatory oversight to ensure the safety of participants. This regulatory oversight includes the requirement that all clinical researcher and staff involved in the trial have basic training in ethics, Good Clinical Practice and the legal standards of the jurisdiction in which they operate. While the required mandatory training for any given study depends on the study design and the role individuals perform, CANTRAIN offers access to three key courses for a comprehensive understanding of the regulatory standards expected for conducting clinical research trials in Canada:
ADAPTED FROM:
- ICH Guidance E6(R2) GCP (International Council for Harmonisation-Good Clinical Practice)
- Health Canada, Part C, Division 5 of the Food and Drug Regulations
- Tri-Council Policy Statement-Ethical Conduct for Research Involving Humans (TCPS 2-2022)
TCPS 2: CORE-2022: To access the nine modules (Course on Research Ethics)
TriCouncil Policy Statement from the Secretariat on Responsible Conduct of Research
COMMON CORE FOUNDATION LEVEL
The CANTRAIN Common Core Foundation is a fundamental (basic or entry level) that comprises eleven courses designed to provide learners of various profiles with a strong knowledge baseline of key concepts in the conduct of clinical trials involving human participants. This is information everyone involved in clinical trials should know and understand, regardless of role. Through this level CANTRAIN modules are tailored, sequenced and assembled in such a way to address the needs for a wide variety of learners (students, clinical research professionals and trialists), selecting optimal content from amongst JTF eight domains and forty-seven competencies.
Curriculum of Common Core Foundation :
- Study Designs and Clinical Trial Phases
- Drug Discovery and Development Process
- The Clinical Trial Protocol
- Patient Engagement in Research
- Roles and Responsibilities in Clinical Research
- Good Documentation Practices
- Ethics and Informed Consent
- Participant Recruitment
- Participant Safety and Adverse Events
- Data Management in Clinical Research
- Study Oversight and Monitoring
Monitoring Mentorship – Each course is enriched by access to mentors – subject matter experts in the field. Interactions between learners and mentors will be conducted through the LMS, to enable engagement activities irrespective of location in Canada, at pre-established date and time. Virtual and in-person interactive sessions will enable learners to explore the field more deeply, explore questions of interest to them, explore the latest ideas in clinical trials design and operations. Sessions may include discussion boards, live presentations, webinars, fireside chats, case conferences, virtual office hours and more. Interactions via the LMS will also promote knowledge mobilization and foster engagement between students, clinical research professionals, trialists and community partners.
Study Designs and Clinical Trial Phases Drug Discovery and Development Process Roles and Responsibilities in Clinical Research Participant Safety and Adverse Events Data Management in Clinical Research Case Scenario of the Common Core Foundation Program
STREAM SPECIFIC LEVEL
CAREER DEVELOPMENT PROGRAM
Welcome to CANTRAIN Career Development Program (CDP) for Graduate and Postdoctoral Trainees (GPT) from across Canada
The CANTRAIN Career Development Program (CDP) caters to graduate and postdoctoral trainees in the health sciences who wish to pursue a fulfilling career in clinical trials.
Program Overview
The CANTRAIN Career Development Program provides a thorough and dynamic learning experience for learners interested in pursuing professional positions in clinical trials operations, regulatory affairs, or medical affairs. The program focuses on practical application and real-world insights, offering learners a unique opportunity to expand their knowledge and gain new skills in this quickly changing industry.
Eligibility.
Exclusively available to graduate or postdoctoral trainees in health sciences currently enrolled at Canadian universities, our program welcomes applicants with or without prior experience in clinical research. Preference will be given to final-year trainees with a keen interest in clinical trial operations, regulatory and/or medical affairs.
Interactive Learning Methods.
Prioritizing hands-on learning, our program offers a range of interactive methods to actively engage learners. From specially crafted online courses to weekly expert-led webinars and collaborative group activities, learners immerse themselves in real-world scenarios and insights from the workplace. Additionally, we have curated diverse learning resources tailored to help participants learn about distinct career paths and objectives.
Program Curriculum.
Our comprehensive curriculum covers essential topics in clinical trials research and includes:
- Clinical Trial Operations: From Lab to Market
- Canadian Health System Overview
- Advanced Drug Discovery: Pre-clinical Insights
- Types of Clinical Trials and Study Designs
- Study Protocol Essentials: From Patient Enrollment to Retention
- Managing Protocols in Practice: Challenges, Solutions, and Risk-Based Management
- Informed Consent and Participant Interaction
- Post-Market Surveillance Strategies and Health Technology Assessments
- Industry Development Pipeline
- Career Exploration, Planning, and Networking
- Essential Professional Skills Development for Future Clinical Research Professionals
Networking Opportunities.
Each live webinar and group collaborative activity offers participants the chance to interact and network with professionals in the clinical research field. These opportunities are invaluable for building connections and exploring career prospects in the industry.
Alumni Success Stories.
Our program alumni have successfully transitioned into a wide range of professional roles within the clinical research industry. Here are just a few examples of the career paths they have pursued:
- Clinical Research Coordinator; Clinical Trial Monitor; Medical Science Liaison; Regulatory Affairs Specialist; Clinical Research Educator; Medical Writer; Medical and Scientific Affairs Specialist; Patient Success Coordinator; Healthcare Investment Analyst; Clinical Operations Manager; Industry Scientist; Clinical Research Program Manager
Flexibility and Accessibility.
Webinars and activities are scheduled weekly, with online content and resources available on demand.
Program Completion.
To successfully complete the program, participants must:
- complete the CANTRAIN Common Core Foundation series of 11 e-learning modules;
- attend at least 80% of webinars and activities,
- complete the regulatory compliance courses (International Council for Harmonisation – Good Clinical Practice (ICH-GCP), Health Canada Part C Division 5 and Tri Council Policy Statement on Ethical Conduct for Research Involving Humans (TCPS-2022) Learn more about these courses.
Application.
Applications are accepted for the summer and winter sessions, with twenty (20) spots available per cohort. The application procedure is competitive, and acceptance depends on the candidates’ fit with the programme.
May 2024: Applications are being accepted now for the 2nd cohort of the CANTRAIN Career Development Program. The program will take place from June to October, 2024. Twenty (20) participants will be accepted. Notice of acceptance into the program will be provided by June 7, 2024. Successful applicants are expected to complete the CANTRAIN Common Core Foundation before the first meeting date on Tuesday, July 8, 2024.
CLINICAL RESEARCH PROFESSIONALS
The Clinical Research Professionals (CRPs) training program aligns with CANTRAIN’s vision of fostering clinical trial research competency through an efficient training environment. It delivers cutting-edge, inclusive educational curricula based on a competency-based clinical trials training curriculum enriched with expert mentorship and experiential learning opportunities.
Designed for learners actively working in clinical research, the CRP program may eventually be opened to learners from other streams who could benefit from taking specific courses within the program as electives
Stream Goals:
- To equip CRPs with essential skills and knowledge for the effective, ethical and safe conduct of clinical trials
- To develop competency-based training to improve real life performance in the workplace
- To provide flexible and tailored solutions for a range of roles/ responsibilities and experience
- To increase the CRPs number, retention and career advancement opportunities
This stream is targeted to:
- Clinical Research Professionals notably; Clinical Research Coordinators/Assistants, Nurse Coordinator, Regulatory Specialists, CRP Managers, Project Managers, Clinical monitors, Quality managers
- Newly hired CRPs aiming to be brought up to speed
- Experienced CRPs aiming to advance their skillset
- International graduates attempting to transfer their practice permits to Canadian regulations
- Laboratory, administrative, data analysts wishing to broaden their knowledge and/or the scope of their work
The program initially targets a sub-stream of CRPs, specifically the Clinical Research Coordinators (CRCs), who constitute a significant portion of CRPs. Their role encompasses a wide array of responsibilities related to study activities at the site.
The program is flexible and tailored to individual learners based on their job roles, responsibilities, and training needs, with no definitive path. It offers courses to help learners understand the clinical research trials environment, manage common day-to-day operations, and develop higher-level skills. This program is designed to serve both newly hired or newly assigned CRCs and experienced CRCs aiming to advance their skillset for trials of varying types, therapeutic areas and phases, or to acquire new skills for additional responsibilities. It includes perspectives from CRCs working in research centers, institutions, and private sites, and those involved in Industry-Sponsored Trials, Investigator-Initiated Trials (IIT), and Lead sites in multi-center, multi-regional IITs.
The program will comprise three fundamental courses: CRC Role and Study Life Cycle; Overview of Implementation and Conduct of Clinical Trials in Canada; and Study Management, Deliverables, and Risks. The rest of the program will primarily consist of microcourses, offering shorter and mobile learning experiences that are flexible and easily accessible for learners, each designed to focus on a specific skill, subject, or topic.
Learners will have the flexibility to choose either all or a selection of microcourses based on their individual needs, which will be determined by their job responsibilities and their level of confidence in performing these duties (whether they are competent or need additional training). A competency assessment tool may be used to create a personalized, tailored competency development plan for each CRC. Microcredentials will be awarded through certificates or digital badges, highlighting the learning outcomes or competencies achieved by the learners.
Learners are encouraged to complete the CANTRAIN Common Core Foundation modules before starting the CRP Stream courses. These modules include the regulatory modules; the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS2) course on Research Ethics, Good Clinical Practice, and Health Canada Division 5 – Drugs for Clinical Trials Involving Human Subjects.
Future program development will focus on addressing the specific training needs of other CRP roles.
TRIALISTS
The Trialist Training Stream focuses on clinicians and scientists who aspire to participate in the conduct of or lead clinical trials. This stream is focused on the design, leadership, execution, analysis, and dissemination of clinical trials and their findings.
Stream Goals
- To increase the number and quality of trial investigators in Canada who are competitive nationally and internationally for clinical trial funding and able to generate the evidence needed to improve the health of individuals in Canada and abroad, and
- To increase the agility, adaptability, and interconnectivity of trial investigators in their response to an ever-evolving healthcare landscape.
Who is this training for
This stream targets:
- Health-care practitioners (e.g., physicians, pharmacists, nurses, exercise physiologists, nutritionists), including those who are community-based and clinician-scientists who are planning to operate a clinical trial site, or design and lead clinical trials as investigators.
- PhD trained researchers and trial methodologists who are planning to design, lead or contribute to the conduct of clinical trials.
About this training
Training included in this stream is designed to equip learners with the skills, knowledge, experience, and support to design, develop, execute, or participate in the conduct of clinical trials, as well as analyze and disseminate results. Learners will gain a foundational through to advanced understanding of the theory and practice of conducting clinical trials and interpreting their results.
Modes of training
The trialist stream will offer a range of self-paced, interactive e-learning modules through the CANTRAIN learning management system. These modules will be supported by structured mentorship provided by established clinical trial investigators and other subject matter experts to elevate the learner from knowledge to competence. In addition to mentorship, learners will have access to stream-specific advanced training, experiential learning, and optional electives leading to specializations. Learners will also have the opportunity to share perspectives and experiences across streams through networking and discussion forums.
PATIENT AND COMMUNITY PARTNERS
Overview
Stream 4 is a comprehensive clinical trials educational initiative developed collaboratively with patient partners for patients, their families, and the public. Stream 4 values the essential contributions of lived experience. Stream 4 courses addresses significant gaps in current training programs by offering information, resources, and skill development content tailored to the diverse needs of patients, families, and the community. Whether individuals wish to familiarize themselves with clinical trials for personal enrichment or aspire to take on roles in designing or leading trials, Stream 4 provides opportunities that emphasize self-fulfillment and personal growth rather than external quality metrics. Our guiding principle is to ensure that research teams engage meaningfully with individuals who have lived experience, thereby shaping research design to genuinely reflect the community’s insights and values
Stream Goals:
- Promote personal enrichment and a deeper understanding of clinical trials among patients, families, and the community.
- Foster meaningful engagement and collaboration between research teams and individuals with lived experience.
- Cultivate a robust foundation of knowledge and skills that enables participants to achieve their personal goals and aspirations within the context of clinical trials.
1. Patients as Participants in Clinical Trials
Description:
In this course, you will be introduced to the fundamentals of clinical trials, including what they are and their critical role in advancing medical research. You will learn how to locate and identify ongoing clinical trials that are actively recruiting participants, which may be of interest to you or members of your community. Additionally, the course will guide you through important considerations when deciding whether participating in a clinical trial is the right choice for you or someone you know. Key topics will include understanding the potential risks and benefits, assessing eligibility criteria, and evaluating the ethical aspects of clinical trials.
2. Patients as Partners in Clinical Trials
Description:
This course emphasizes collaboration and partnership, offering essential knowledge and resources to support patients, families, and community members who wish to actively engage with researchers and healthcare providers in clinical trials. The course covers how to recognize and address tokenism, provides an overview of tools and strategies to incorporate patient and community perspectives into clinical trials, and includes guidance on identifying and pursuing partnership opportunities. By focusing on these areas, the course aims to strengthen effective collaboration and ensure meaningful contributions from all stakeholders involved in the research process.
3. Patient Advocacy in Clinical Trials
Description:
This course equips participants with the skills needed to advocate for patient-centered approaches in clinical trials. The patient advocacy modules offer tailored learning opportunities designed to empower patients and community members in developing and refining their abilities to effectively support both patient needs and the advancement of clinical research. These modules focus on enhancing participants’ skills to navigate healthcare systems, communicate effectively with stakeholders, promote patient-centered policies, and raise awareness about the significance of clinical research. By providing these skills, the course fosters a proactive approach to championing patient interests in clinical trials, aiming to improve healthcare outcomes and increase patient engagement.
4. Patient Leadership in Clinical Trials
Description:
This course is designed for individuals interested in taking a leading role in research and clinical trials. It provides guidance for patients, caregivers, and community members on how to become co-researchers or lead their own research projects. The patient peer researcher modules offer structured learning opportunities aimed at empowering participants to develop and refine leadership skills essential for initiating, managing, and conducting research. Key topics include finding funding, writing grants, and understanding dissemination and authorship. Additionally, the course covers the responsibilities of a Principal Investigator (PI) and links to modules on Good Clinical Practice (GCP) and administrative or legal aspects of research. By focusing on these areas, the course aims to equip individuals with a comprehensive understanding of research methodologies, ethical considerations, and regulatory frameworks necessary for leading rigorous and impactful investigations.
How to Get Involved
To start your journey with Stream 4, simply register on the CANTRAIN learning platform. During registration, you’ll share details about your experience, interests, and preferred learning pathway. All courses and resources are offered at no cost, making them accessible to everyone. For more information and to sign up, visit the CANTRAIN Clinical Trial Training Programs page.
