The Collaborative Institutional Training Initiative (CITI) training courses, recognized by TransCelerate, are part of an extensive, trackable, accredited online training program customized for the Canadian clinical research infrastructure.
Please allow a minimum turnaround time of one business day for course activation.
The Collaborative Institutional Training Initiative (CITI) – Canada Education Program
In 2010 N2 partnered with the Collaborative Institutional Training Initiative (CITI), a not-for-profit entity at the University of Miami, which has since become part of the Biomedical Research Alliance of New York (BRANY).
N2 has the rights to add and modify all CITI-content to ensure it reflects and meets the educational needs of the Canadian research environment.
The CITI-Canada Program offers comprehensive courses on a variety of research related matters. The courses include a quiz after each module to test the learner’s knowledge. Following successful completion of the course, the learner is able to obtain a completion certificate. This can be used to demonstrate compliance with the regulatory requirements for education in the respective topics. The organization will be able to run aggregate reports on all staff in its organization to track completion of the respective courses.
N2 provides access to the CITI-Canada program for N2 member organizations. N2 does provide limited access for individuals for a nominal fee. If you are not a member but interested in accessing the program please contact us.
If you are wondering why you should take CITI-Canada’s research ethics tutorials, you can read the following summary addressing the evaluation of requirements for education in research ethics in Canada and a comparison of available online tutorials.
Good Clinical Practice Course
This course is a 10-module program that discusses good clinical practice as it relates to clinical trials. The discussion is focused on the International Council for Harmonisation (ICH)-E6 (R2) guidelines and applicable regulations in Canada such as Health Canada-Division 5, and The Tri-Council Policy Statement 2.
CITI Canada’s GCP Courses were revised to reflect the updated ICH Harmonised Guideline Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2). GCP Courses – Version 2 – now specifically refer to the current ICH E6(R2) guideline and provide ICH E6(R2) training.
Both CITI Canada GCP courses meet the minimum criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma as necessary to enable mutual recognition of GCP training among trial sponsors. Both the GCP Basic and Refresher courses are available in both French and English. The translation of the course was accomplished with financial support from Fond de Recherche Sante (FRQS) and with review support from Consortium de recherche en oncologie clinique du Québec (Q-CROC) . N2 is grateful for their contributions.
Good Clinical Practice (GCP)
- Version 1 – 28 Mar 2014
- Version 2 – 4 Apr 2018 (includes E6 R2 updates)
CITI Canada GCP Refresher
- Version 1 – 19 Mar 2015
- Version 2 – 25 Jan 2017 (includes E6 R2 updates)
Who should take this course: The course is suitable for persons proposing to conduct clinical trials primarily in Canada. “TransCelerate BioPharma” which represents a number of biopharmaceutical companies has recognized that the CITI Canada Good Clinical Practice course meets their criteria for ICH GCP training for investigator site personnel. This is significant in that N2 has worked with TransCelerate to assure that the high quality CITI Canada GCP course accessible to N2 members meets their standards. This means if you are working with a TransCelerate affiliated company you can assure them that your CITI Canada training has formal approval and recognition from TransCelerate. Meeting TransCelerate training criteria is the latest milestone in a trend that has seen many biopharmaceutical companies as well as research networks, hospitals and universities accept the CITI Canada GCP course as their gold standard.
Human Subjects Research (HSR)—Biomedical
The Human Subjects Research (HSR) – Biomedical Focus course consists of 9 modules and provides historic and current information on regulatory and ethical issues important to the conduct of research involving human participants. The discussion is focused on introducing Research Ethics Guidelines and regulations; Research Ethics Boards and Ethics review process; Harms and Benefits; the Process of Free and Informed Consent; Privacy and Confidentiality; Conflict of Interest, and Special Research Design Issues.
Who should take this course: The basic course modules are suitable for all persons involved in biomedical research studies involving human participants.
Human Subjects Research (HSR) —Social and Behavioral Focus (Currently disabled to allow for updates)
The Human Subjects Research (HSR) – Social and Behavioral Focus course consists of 13 modules and provides basic information about the ethical conduct of research with human participants in the social, behavioral, and education sciences. Modules include: History and Ethical Principles; Defining Research with Human Participants; The Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, 2nd edition and the Review of Research in the Social and Behavioural Sciences; Assessing Risk in Social and Behavioural Sciences; Informed Consent; Privacy and Confidentiality; Research with Children; Research in Vulnerable Circumstances; Internet Research and Conflicts of Interest.
Who should take this course: The basic course modules are suitable for all persons who conduct or review or who have responsibilities for setting policies and procedures with respect to social, behavioral, and educational research.
Responsible Conduct of Research – RCR Mega Course
How should you conduct your research? What practices should you follow? Researchers are expected by the public and by their colleagues to follow many rules and commonly accepted practices. The Responsible Conduct of Research (RCR) courses provide the learner with a solid foundation of knowledge relating to the norms, principles and rules governing responsible research practice in Canada. List of Modules for RCR Mega course:
Introduction to RCR; Ethics and the Responsible Researcher; Publication Practices and Responsible Authorship; Collaborative Research; Conflicts of Interest; Data Management; Mentoring; Peer Review; Writing with Integrity; Research Involving Human Subjects; Research Misconduct; Using Animal Subjects in Research
WHO SHOULD TAKE THIS COURSE? These courses are suitable for researchers, students and other personnel from a variety of disciplines and fields.
Transportation of Dangerous Goods/ International Air Transport Association (TDG/IATA)
Compliance with the Transportation of Dangerous Goods/ International Air Transport Regulations has become increasingly important. Specific training for investigators and staff Transportation of Dangerous Goods/ International Air Transport Regulations is essential to ensure that all people conducting research with dangerous materials, agents or devices are in compliance with all applicable laws. The course consists of 6 modules and covers the following: Introduction; Classification; Marks of Safety; Packaging and Containment Systems, Marking and Labeling; Documentation; ERAP and Accidental Release Reporting.
Who should take this course: The course is suitable for a broad range of audiences ranging from researchers working in labs that handle dangerous goods to clinical research staff or anyone involved in the transportation of dangerous goods and /or international air transport.
Please note that if you are interested in Transport Canada’s position on this course, and have checked their website, the list of organizations on the Transport Canada page is not complete, and they state that they have not examined or certified any of the courses listed there. In the future N2 will work with Transport Canada to have the online CITI course added to the list.
The CITI TDG course meets the requirements for training. The TDG training requirements are quite non-specific and leave most of the responsibility to the employer. The employer determines whether an employee needs to be trained and what kind of training is necessary, and the employer is also the one who issues the certificate of training. It is therefore up to the site and users of the course to determine if additional education is beneficial.
Health Canada Division 5: Drugs for Clinical Trials Involving Humans
The Food and Drugs Act and the Food and Drug Regulations govern the sale and importation of drugs for use in human clinical trials in Canada. Specifically, Part C, Division 5 of the Regulations addresses drugs for clinical trials involving human participants. Health Canada tells us that the Qualified Investigator must ensure compliance with the Regulations and the International Conference on Harmonisation Good Clinical Practice (ICH-GCP E6) Guideline (incorporated in the Regulations) from every person involved in the conduct of the clinical trial at their site. To that end, there should be evidence of satisfactory training of personnel involved in these processes. The successful completion of this CITI-Canada course can be used as evidence of training in Division 5 Regulations. This “Division 5” course covers all research conducted under Division 5 Regulations and it provides practical solutions and methods for complying with the Regulations. This course is available in both French and English.
Privacy (Currently disabled to allow for updates)
The Introductory Course on Privacy and Security for Personal Health Information in the Canadian Health Research Environment was developed for CITI-Canada in order to provide learners with an understanding of privacy and security requirements for health research with humans. This course provides important information, based on accepted privacy and security standards and regulatory requirements, for the appropriate collection, use, dissemination retention and destruction of PHI within the health research environment. The materials will address requirements set out in guidance documents such as the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS) as well as federal, provincial and territorial legislation. Arguably the most important source of federal law on privacy, and one which will be highlighted in this course, is PIPEDA: Personal Information Protection and Electronic Documents Act.
The target audience for this course is anyone who administers, reviews or conducts health research (which is research that involves the collection of health data such as occurs in – but is not limited to – clinical research).
Clinical Research Coordinators (CRC)
The Clinical Research Coordinator (CRC) Course was developed for CITI-Canada in order to provide learners with a basic understanding of the elements involved in being a CRC. This course is intended as foundational role-based training for learners needing basic CRC training or organizations needing on-boarding training for new CRCs. It offers learners a foundation that expands beyond but is directly connected to the Biomedical Research Ethics course and the Good Clinical Practice (GCP) training offered by N2/CITI-Canada. We recommend you complete the N2/CITI-Canada course on “Biomedical Research Ethics” which provides an excellent background on research ethics involving human participants, prior to completing this course. List of Modules for CRC course:
4.Working with the Research Ethics Board (REB)
5.Protocol Review and Approvals
6.Principal Investigator (PI) Responsibilities
7.Clinical Research Coordinator (CRC) Responsibilities
12.Overview of the Clinical Trial Agreement (CTA)
13.Coordinating U.S. Regulated Studies – What to Consider?
WHO SHOULD TAKE THIS COURSE?
The content of this course is intended for CRCs, investigators, and other clinical research professionals. It is also useful to those pursuing a career in clinical research. This course is recommended for clinical research staff who have 1-2 years’ experience in clinical research.