Research Contracts conducts a series of webinars geared to investigators and research administrators. These highly informative lectures attract national and international participants, and offer a forum for discussion of timely and relevant topics.
All local principal investigators involved in clinical trials, as defined by the Tri-Council Policy Statement 2 (TCPS2), at Hamilton Health Sciences and McMaster University must submit proof of GCP Certification Training when submitting an application to the Hamilton integrated Research Ethics Board (HiREB). A certification number is issued to all individuals who complete the CITI-GCP online program. Those who complete another accredited GCP program must provide a copy of the program outline and completion certificate. Alternate acceptable GCP training include:
If you are not sure whether an alternate GCP training program is acceptable, you may send the program outline and completion certificate to Research Administration, firstname.lastname@example.org for review.
To obtain log-in instructions or if you have any questions about CITI Canada GCP online training, please connect with your respective institution contact:
GCP training provides the research community with insight into the rules and regulations that are applicable to clinical trials, but also highlights the roles and responsibilities of a principal investigator, the complexities of informed consent, personal information, storage of materials, etc. that provides a basic education platform on the standards of practice for conducting research.
As stated on page 147, the Social Sciences and Humanities Research Council of Canada, Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, December 2010,
For the purposes of this Policy, a clinical trial, a form of clinical research (also known as patient-oriented research), is any investigation involving participants that evaluates the effects of one or more health-related interventions on health outcomes. Interventions include, but are not restricted to, drugs, radiopharmaceuticals, cells and other biological products, surgical procedures, radiologic procedures, devices, genetic therapies, natural health products, process-of-care changes, preventive care, manual therapies and psychotherapies.
Clinical trials may also include questions that are not directly related to therapeutic goals - for example, drug metabolism - in addition to those that directly evaluate the treatment of participants. Clinical trials are most frequently undertaken in biomedical research, although research that evaluates interventions, usually by comparing two or more approaches, is also conducted in related disciplines, such as psychology. The researcher leading a clinical trial is often (but not always) a clinician, that is, a health care provider (e.g., physician, dentist, naturopath, nurse, physiotherapist). Although various types and forms of clinical trials have methodological differences, the ethical principles and procedures articulated in this Policy are applicable, and can be adapted as needed. Researchers and research ethics boards (REBs) should consult the other chapters of the Policy for additional guidance on principles, norms and practices applicable to all research.
To obtain GCP training, please visit www.CITICANADA.org. There are 12 modules to complete. The Medical Device module is not required if you do not conduct medical device studies. Each module takes approximately 15 minutes. You may log in and out of the program as many times as you like to complete the required components.
HHS, SJHH and McMaster encourage individuals who have completed prior GCP Training (more than 2 years) to update their training through the Canada CITI-online GCP Training that is available at no cost. There is no mandate (at this time) requiring individuals to refresh/update previously completed GCP training; however, HHS, SJHH, and McMaster strongly recommend individuals to consider upgrading their training, every 2 years, including it with other professional training requirements.
Upon completion of the program, individuals will be prompted to print a Canada GCP Curriculum Completion Report (Word file) at no cost. The completion number along with a list detailing each module covered and associated scores is included on this report.
Hamilton Health Sciences is providing the GCP system through its membership in the Network of Networks (N2), which is a Canadian alliance of research hospitals, universities and other research organizations. N2 investigated GCP training tools internationally and selected a US-based CITI GCP online training system to Canadianize with funding support made possible from CIHR and a Canadian Regulatory consultant. This system is being adopted widely across Canada by N2 member organizations (200+) and is being provided to you at no cost.
No. Good Clinical Practice training is considered to be one of the essential learning elements that the HHS Executive Council on Research has determined for its investigators (and applicable research personnel) that fits in with other annual learning objectives and training that is required in order to carry out research activity at HHS. The training program of choice (Canada CITI) allows individuals to access the system from any computer with an internet connection. The system will save entries to facilitate revisiting the training in small blocks of time to complete at leisure.
Research personnel (e.g., research nurses, research coordinators, assistants, data entry staff, etc.) are not mandated to complete this training; however, the Tri-Council Policy expects principal investigators to be responsible and accountable for appropriate training of research team members. Therefore, it cannot be assumed that their training needs are exempt.
The conduct of research at Hamilton Health Sciences, in affiliation with McMaster University, requires you to know about protecting personal health information. Enclosed in the table below are hyperlinks connecting you to tools and resource material issued by the Information and Privacy Commissioner of Ontario Office. These documents highlight what you need to know about protecting patient privacy.In addition, if you are using a mobile device in connection with health research at Hamilton Health Sciences that contains personal health information, you are responsible for ensuring that the information is encrypted as per Hamilton Health Sciences’ Encryption Policy.