General Clinical Trials Information
Clinical Trials Education and Awareness
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.
Research Participants Bill of Rights
Working With Patients
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 principles that we will use moving forward when we undertake this type of collaboration again. We hope you find this document useful.
Professional Education and Training
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.
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
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
How should you conduct your research? What practices should you follow? Researchers are expected by the public, their colleagues, their institutions, and their funding sources to behave with integrity. The Responsible Conduct of Research (RCR) collection of courses provides the learner with a solid foundation of knowledge relating to the norms, principles, and rules governing responsible research practice.
Who should take this course: The course modules are suitable for researchers, students and other personnel from a variety of disciplines and fields. The modules cover Introduction to the Responsible Conduct of Research; Ethics and the Responsible Researcher; Data Acquisition and Management; Research Misconduct; Peer Review: Role and Process in Life Sciences Research; Publication Practices and Responsible Authorship; Responsible Mentoring; Collaborative Research; Animal Care and Use; Conflicts of Interest in Research and Human Participants Research and Ethics.
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.
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).
To Access These Courses
The N2 SOPs Version 7 with an effective date of May 15, 2017 are now available to N2 members. They include English and French versions. 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.
Notice: Updated REB SOP 701
Please note that REB SOP 701 has been updated to version 701.002_1 and is effective immediately. The revisions are described in the SOP History at the end of the document. This is a minor revision, in keeping with recent policy changes, and the SOP retains the version 2 date of March 8, 2016.
Access to the REB SOP documents and associated information can be obtained from the following link: https://oicronca.box.com/s/ro3y57gpwhfmyp9oomeyr74jmwh9smcd
The previous version of the document will be archived and accessible.
The V.1 N2 CAREB REB SOPs will be moved to Archive V.1 N2 CAREB REB SOP folder so they remain accessible.
NOTE: Comments, questions and other feedback should be directed to the REB SOP Committee Chair, Alison van Nie at email@example.com
N2/CAREB-ACCER REB SOPs
N2/CAREB-ACCER REB SOPs available open source click here
- CAREB-ACCER and N2 are 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.
Comments, questions and other feedback are encouraged and should be directed to the REB SOP Chair by contacting:
Alison van Nie firstname.lastname@example.org
The REB SOPs are now available in French. To access them please click here
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 Karen Arts for any comments or questions related to the Biospecimen SOPs at firstname.lastname@example.org
Clinical Trials Registries
The World Health Organization (WHO) provides information about clinical trials across the world:
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:
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:
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:
The Canadian Association of Research Ethics Boards (CAREB) is a Canadian membership organization intended to represent the interests of all Canadian Research Ethics Boards (REBs) and to reflect REB perspectives and concerns.
The FDA is the USA regulatory agency that oversees drug and device development in the US. These links take you to the actual regulations:
References / Journals
This online journal provides interesting articles and readings about clinical research: Journal of Clinical Research Best Practices
Applied Clinical Trials is a free journal that provides many articles on clinical research related matters:
The Drug Information Association is an international organization that provides many resources and conferences related to clinical research:
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.
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