This 10-module program provides comprehensive education on Good Clinical Practice (GCP) as it applies to clinical trials. The course focuses on the International Council for Harmonisation (ICH) E6(R2) guidelines, alongside Canadian regulations such as Health Canada Division 5 and the Tri-Council Policy Statement 2 (TCPS 2).

The CITI-Canada GCP courses were fully revised to align with the ICH Harmonised Guideline E6(R2): Good Clinical Practice, ensuring up-to-date, internationally recognized training. Both the Basic and Refresher versions are available in English and French, with translations supported by Fonds de Recherche du Québec – Santé (FRQS) and Consortium de recherche en oncologie clinique du Québec (Q-CROC). N2 is grateful for their valuable contributions.

Both GCP courses meet the ICH GCP Investigator Site Personnel Training criteria identified by TransCelerate BioPharma, allowing for mutual recognition of GCP training among trial sponsors. This recognition underscores N2’s commitment to providing high-quality, accessible education that meets the standards of biopharmaceutical companies, research networks, hospitals, and universities across Canada.

Course Versions

• Version 1 — March 28, 2014

• Version 2 — April 4, 2018 (includes ICH E6(R2) updates)

Who Should Take This Course?

This course is designed for individuals conducting clinical trials in Canada, particularly those working with TransCelerate-affiliated sponsors. Completion of the CITI-Canada GCP course assures compliance with recognized training standards, making it widely accepted as the gold standard by biopharmaceutical companies, research institutions, hospitals, and academic organizations.

This 7-module refresher course reinforces Good Clinical Practice (GCP) principles for clinical trials, focusing on ICH E6(R2) guidelines and Canadian regulations such as Health Canada Division 5 and the Tri-Council Policy Statement 2 (TCPS 2).

The course has been updated to align with the ICH Harmonised Guideline E6(R2), ensuring that learners receive current, internationally recognized training. It meets the ICH GCP Investigator Site Personnel Training criteria set by TransCelerate BioPharma, enabling mutual recognition of GCP training across trial sponsors.

Both the GCP Basic and GCP Refresher courses are available in English and French, with translation support provided by FRQS and Q-CROC. N2 acknowledges and appreciates their contributions.

Course Versions:

• Version 1 — March 19, 2015

• Version 2 — January 25, 2017 (includes ICH E6(R2) updates)

Who Should Take This Course?

This course is designed for individuals conducting clinical trials in Canada who require a refresher on GCP principles. It is particularly relevant for those working with TransCelerate-affiliated sponsors, ensuring your training meets recognized industry standards accepted by biopharmaceutical companies, research networks, hospitals, and universities.

How should you conduct your research? What practices ensure integrity and compliance?

Researchers are expected—by their peers, institutions, and the public—to follow established norms, ethical principles, and regulatory requirements.

The Responsible Conduct of Research (RCR) course provides a comprehensive foundation on the standards and expectations that govern responsible research practices in Canada. Through a series of focused modules, learners gain essential knowledge to uphold research integrity across disciplines and roles.

Course Modules Include:

• Introduction to RCR

• Ethics and the Responsible Researcher

• Publication Practices and Responsible Authorship

• Collaborative Research & Conflicts of Interest

• Data Management

• Mentorship Responsibilities

• Peer Review Standards

• Writing with Integrity

• Research Involving Human Subjects

• Research Misconduct

• Research Involving Animal Subjects

Who Should Take This Course?

This course is designed for researchers, students, and research personnel across a variety of disciplines who seek to strengthen their understanding of responsible research practices.

Compliance with Transportation of Dangerous Goods (TDG) and International Air Transport Regulations is critical for anyone handling dangerous materials, agents, or devices in research. Specific training for investigators and staff helps ensure adherence to applicable laws and safety standards.

This 6-module course covers:

• Introduction to TDG and IATA regulations

• Classification of dangerous goods

• Safety markings, packaging, and containment systems

• Marking and labeling requirements

• Documentation procedures

• Emergency Response Assistance Plans (ERAPs) and Accidental Release Reporting

Important Note:

TDG training requirements under Transport Canada are employer-specific. Employers are responsible for determining necessary training, issuing training certificates, and ensuring compliance. The certificate provided by CITI does not fulfill Transport Canada’s certification requirements but is widely used by N2 members as a refresher or supplemental education tool. Sites should assess whether additional formal training is required.

Who Should Take This Course?

Suitable for researchers, lab staff, clinical research personnel, and anyone involved in the handling or transportation of dangerous goods.

This 9-module course explores key ethical and regulatory considerations in conducting biomedical research involving human participants.

It provides both historical context and current practices to help learners understand their responsibilities in protecting research participants.

Topics include:

• Canadian and international research ethics guidelines

• The role of Research Ethics Boards (REBs) and the ethics review process

• Risk, benefit, and harm assessment

• Free and informed consent

• Privacy and confidentiality

• Conflicts of interest

• Special considerations in research design

Who Should Take This Course?

This course is appropriate for anyone involved in biomedical research with human participants, including investigators, coordinators, and research staff.

The CRC Course provides foundational, role-based training for individuals working—or preparing to work—as Clinical Research Coordinators. It’s ideal for onboarding new CRCs or supporting early-career professionals seeking a clear understanding of the CRC role.

The course connects directly to N2/CITI-Canada’s Biomedical Research Ethics and Good Clinical Practice (GCP) courses. We recommend completing the Biomedical Research Ethics course first, as it offers important background on research involving human participants.

Modules Include:

• Introduction to Clinical Research Coordination

• Planning Research & Securing Funding

• Working with Research Ethics Boards (REBs)

• Protocol Review, Approvals & Site Management

• PI, CRC, and Sponsor Responsibilities

• Informed Consent & Participant Communication

• Clinical Trial Agreements (CTAs)

• Coordinating U.S. Regulated Studies

• Tools, Resources, and Best Practices

Who Should Take This Course?

Designed for CRCs, investigators, and research professionals—especially those with 1–2 years of experience or those entering the field.

Research organizations are increasingly challenged with managing and protecting the personal information collected during the research process. To support best practices, N2 developed this introductory course on privacy and security for personal information (PI) and personal health information (PHI) in the research environment.

The course provides learners with a foundational understanding of:

• Privacy legislation governing the collection, use, sharing, access, and disposal of PI and PHI

• Principles of records and information management

• Best practices for preventing and responding to privacy breaches

Who Should Take This Course?

This course is designed for anyone who administers, reviews, or conducts health research—including clinical trials—that involves collecting or handling health data.

For access, please contact: n2@n2canada.ca

This course provides an overview of key topics related to conducting medical device trials in Canada.

It covers medical device risk classifications, relevant ISO standards, investigator responsibilities, and the process for obtaining Investigational Testing Authorization (ITA). Learners will also explore licensing submission requirements, trial monitoring and auditing, and the differences between Canadian and U.S. regulatory frameworks for medical device research.

For access, please contact: n2@n2canada.ca