General Clinical Trials Information
Public Engagement Toolkits and Resources
N2 has created a number of resources including a Public Engagement One-Pager Tools in Action Guide. This guide bundles all of the resources together with practical tips and examples on how to use them at your site or research institution. Public access to this resource can be found here.
It Starts With Me Toolkit (ISWM/CCAM)
www.itstartswithme.ca / www.cacommencavecmoi.ca is the central resource created to help potential participants, families, caregivers, and the general public to understand basics about clinical trials and clinical research.
1. Ask Me Campaign Toolkit
This toolkit is aimed at raising clinical research awareness at your site, and in the general population. It incorporates promotion of resources like “ItStartsWithMe.Ca/CaCommenceAvecMoi. Ca” and dovetails with Permission to Contact (PTC) initiatives. Adapted from the 3CTN Ask Me Campaign.
• Roll Out Package to help to make the process as “turn-key” as possible
• A wonderful first step if your organization is new to patient engagement or clinical trial awareness activities.
Great conduit for Patient and Public Involvement
2. Permission to Contact Toolkit (PTC)
A resource guide to support Canadian healthcare organizations with permission to contact as a strategy to improve recruitment of research study participants.
3. Recruitment Brochure for Clinical Trials/Research
4. Research Participant Bill of Rights
N2 partnered with the Harvard Catalyst group to “Canadianize” their participant bill of rights. It is available in English and French.
5. Working With Patients or Caregiver Partners
All of N2’s ItStartsWithMe/CaCommenceAvecMoi materials were created in collaboration with patients and caregivers. To share what we learned about this experience, we have created this document to share with you in English and French. We have also developed some guiding principles to use moving forward when N2 subcommittees or members undertake this type of collaboration again. We hope you find this document useful.
N2 fulfils the Help desk functions for all questions or queries related to CITI Canada. Please contact firstname.lastname@example.org or 519-777-7716 for assistance.
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 – English and French
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 Behavioural Focus
The Human Subjects Research (HSR) – Social and Behavioural Focus course consists of 13 modules and provides basic information about the ethical conduct of research with human participants in the social, behavioural, 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) – English and French
*Please note that the employer is responsible for providing the certificate of training per Transport Canada Regulations
Compliance with the Transportation of Dangerous Goods/ International Air Transport Regulations has become increasingly important. Specific training for investigators and staff on Transportation of Dangerous Goods/ International Air Transport Regulations is essential to ensure that all people conducting research using 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; Emergency Response Assistance Plans (ERAPs) 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 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. This certificate has very specific requirements, and the one you will receive from CITI does not met these requirements. It is therefore up to the site and users of the course to determine if additional education is required or beneficial. Many of our members use this course as a refresher.
Health Canada Division 5: Drugs for Clinical Trials Involving Humans – English and French
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 (R2) 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.
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) – English and French
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.
To Access These Courses
For Independent Learners
If you are not affiliated with an N2 site,
The cost is $292.00 + tax per course per person. Your access is for one course for one year from the date of completing the first online module. We offer the following courses:
Good Clinical Practice (GCP) Basic Course French and English
Good Clinical Practice (GCP) Refresher (recommend completion of Basic course first) French and English
Basic Biomedical Research Ethics
Transportation of Dangerous Good-TDG/IATA
Health Canada Division 5
French Health Canada Division 5
Clinical Research Coordinator Course English and French
If you would like to purchase access by credit card, please follow this direct link to the Course Registration page on our website:
N2 Clinical Research SOPs
2023 N2 Clinical Research Standard Operating Procedures
We are excited to announce the launch of the 2023 English N2 Clinical Research Standard Operating Procedures (SOPs), effective May 31, 2023. The French version is currently in translation and will launch soon. Please do not share them outside of N2. If you are interested in finding out how to become a member of N2, please click here.
N2 REB Standard Operating Procedures
N2 REB Standard Operating Procedures available open source click here
N2 is pleased to provide a set of collaboratively developed, standardized, Canadian REB SOPs via open access. [English and French versions] The REB SOPs are specific to ethics boards that review health sciences research and are compliant with applicable Canadian and US regulatory, and ethics guidance criteria. The implementation of the REB SOPs will facilitate the distribution, adoption and maintenance of a single standard for REBs in Canada.
Please note that changes to the formal set of REB SOPs may result in the SOPs no longer being compliant and it is for this reason that the SOPs appear as print only PDF documents.
According to the Terms of Reference, re-versioning of the SOPs will be completed when required and as often as changes are needed. Decisions related to the frequency of any revision(s) will be made following an assessment of the proposed change(s) and a determination of the urgency including relevance to the users.
Comments, questions and other feedback are encouraged and should be directed to the REB SOP Chair by contacting Jacqueline Senych: Jacqueline.Senych@albertainnovates.ca.
N2/CAREB-ACCER Observational Health REB SOPs
The Standard Operating Procedures for REBs that review Observational Health Research (Observational Health SOPs) were developed for REBs that do not normally review regulated clinical trials, and therefore do not need to comply with the more prescriptive standards and regulations such research requires. These SOPs have been designed for use by REBs that may review non-clinical trial biomedical, population and global health, and socio-behavioural research. They may also be used for REBs that review other types of research that involve human participants such as scholarship on teaching and learning, management, and humanities. The Observational Health SOPs, which use the N2/CAREB-ACCER REB SOPs as the foundation, have been developed to be compliant with TCPS only. They are meant to be flexible in style, as the TCPS is, with allowances for institutions to make changes as needed (so long as they remain compliant with TCPS). Guidelines will be developed on topics related to the SOPs, such as methods of consent, privacy legislation, and conflicts of interest.
For any questions or suggestions for improvement, please contact Rachel Zand.
Biospecimen Related SOPs
The availability of high quality biological specimens is of utmost importance for cancer clinical trials and research. Standardizing methods for collection, long-term storage, retrieval and distribution of specimens across collection sites is essential to ensure the quality of the samples and enable consistent analysis of DNA, RNA and proteins.
Whereas regulations exist to provide direction in many aspects of clinical research conduct, to date there are no formal regulations that direct the collection, and management of biospecimens. In the absence of such regulations, common Standard Operating Procedures (SOPs) are an ideal tool to establish standardization for repositories and clinical research sites. In Ontario, while many samples are collected across a multitude of sites, lack of standardized methods and lack of consistent SOPs jeopardize quality of the samples and the ability to use the samples for future research. The Ontario Institute for Cancer Research’s High Impact Clinical Trial (HICT) program, in collaboration with the Ontario Translational Research Network (OTRN) facilitated a collaborative effort to modify, harmonize and expand existing biospecimen SOPs.
The SOP set is organized into three levels:
- Overall General SOPs (000 series) to guide both clinical trials and biorepositories;
- Biorepository SOPs (100 series);
- Clinical Trial related SOPS (200 series)
In addition to this “overarching” set, to be adopted by each site to guide the overall practice, each site may develop additional SOPs, appendices and/or tools to complement this set to outline specific local details.
The SOPs can be accessed here.
Any clinical trial related matter that is not unique to biospecimens is outlined in the Network of Networks (N2) SOPs, available to N2 member organizations. These can be accessed through N2. if you are interested in an N2 membership, contact N2′s coordinating office at email@example.com
Please contact Stephen Sundquist for any comments or questions related to the Biospecimen SOPs at Stephen.Sundquist@oicr.on.ca
Clinical Trials Registries
Canadian Cancer Trials is a site where you can find information about Cancer Clinical Trials in Canada:
ClinicalTrials.gov is a registry and results database of federally and privately supported clinical trials conducted in the United States and around the world.
ClinicalTrials.gov gives you information about a trial’s purpose, who may participate, locations, and phone numbers for more details. This information should be used in conjunction with advice from health care professionals:
Health Canada’s clinical trials database
A listing of specific information relating to phase I, II and III clinical trials in patients:
International Standard Registered Clinical/soCialsTudy Number (ISRCTN)
Searchable clinical trial registry whether proposed, ongoing or completed:
Guidelines and Regulations
Health Canada is the Canadian regulatory agency that oversees drug and device development in Canada. This link takes you to the actual regulations:
Health Canada has adopted the ICH-Good Clinical Practices Guidelines for the conduct of clinical trials in Canada. This link takes you to the GCP guidelines:
Permission to Contact Toolkit (PTC)
- Project management for implementation of the Platform
- Staff engagement and training
- Creation of standard operating procedures and forms
- Assistance with ethics application
For more information about PTC consulting services, please contact BRC.
Not a member of N2? Sign Up as a new member of N2 now!
The Initiative to Streamline Clinical Trials
The 2011 Canadian Cancer Research Alliance (CCRA) report on the State of Cancer Clinical Trials In Canada identified the magnitude of the threat to the conduct of oncology clinical trials. The Report noted that with falling performance metrics, increasing complexity and workload, and an increasingly onerous regulatory environment, clinical trials were at risk, and observed that “Without clinical trials, the outcomes of cancer patients will not continue to improve”. The report recommended engaging with Health Canada and other key stakeholders to foster agreement in appropriate interpretations of the Health Canada Food and Drug Regulations and ICH Good Clinical Practice (GCP) guidelines.
The Initiative to Streamline Clinical Trials (ISCT) Working Group, formed in 2012 to address the CCRA recommendations, includes members who are experts in clinical trial conduct across many therapeutic areas. The primary objective of the ISCT was to develop specific, pragmatic and practical interpretations of current regulations, laws and guidelines, in order to facilitate, rather than limit, Canadian clinical trials, by expanding on recommendations such as those of the CCRA and OECD. During the discussions, it became apparent that changes to certain regulations or laws interpretations were also desirable.
The focus of ISCT encompassed academic clinical trials of drugs and/or biologics which are required to be, or interpreted as required to be conducted under a Clinical Trials Application. Academic trials are defined as trials where the regulatory sponsor of the clinical trial is not a commercial for-profit organization such as a pharmaceutical company or contract research organization (CRO).
The ISCT Recommendations were finalized in February 2014. The Recommendations are summarized below in a tabular format. Each recommendation was categorized as being feasible within the current regulatory framework, or if it was felt that changes to existing regulations or laws were required, as recommended. The complete document can be downloaded from this site. In many sections, sample documents or checklists will be available and will also be downloadable.
The final Recommendations of the ISCT are provided here to all participants as well as academic groups and investigators in Canada. Place links to the Recommendations on your websites if appropriate and ensure your members are aware of the Recommendations.
A summary of the recommendations is provided below for your convenience.
We hope that you will agree to provide your contact details so we can evaluate which area/s of the Recommendations have been implemented and also assess the impact of the Recommendations on the conduct of academic clinical trials in Canada by means of annual surveys.