SOPs & GCP

training-and-educationHHS Research, through its affiliated membership with N2 Canada, has access to training, tools, information, resources, and a set of Standard Operating Procedures (SOPs) templates for conducting a clinical trial. 

SOPs are critical to quality performance and ethical conduct of clinical trials. SOPs indicate the level of professionalism by providing documented procedural guides and help ensure consistency, compliance, accountability and efficiency of the investigator and investigator’s team in conducting clinical trials that are expected by regulatory authorities when conducting audits. 

Good Clinical Practice (GCP) Certification Training is a regulatory requirement [as defined by the TriCouncil Policy Statement 2 (2014)], as well as an institutional requirement (for submission of HiREB applications) for conducting clinical research activities that ensures compliance with best practices.  In addition, more and more regulatory and sponsor monitoring visits are requesting evidence of training for all research team members, not just the investigator. See pdf document for details of the TriCouncil Policy Statement 2 (2014).

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).

No-fee access to a set of SOP modules and GCP training certification, is available to researchers and their team members through institutional administrators:

Hamilton Health Sciences: Daniela Bianco, Manager – Research Development and Relations

St. Joseph’s Healthcare Hamilton: Adam Weerdenburg, Research Quality Assurance Officer

McMaster University, FHS: Augusta Beck, Senior Advisor – Major Programs

Good Clinical Practice FAQ

  • Why is Good Clinical Practice (GCP) Certification Training required?

    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.

  • How is 'clinical trials' defined by the Tri- Council Policy Statement?

    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.

  • How do I get started?

    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.

  • How often is GCP Certification Training required - e.g., annually?

    HHS, SJHH and McMaster encourage individuals who have completed prior GCP Training (more than 3 years) to update their training through the CITI Canada -online GCP Training that is available at no cost. At this time, there is no mandate requiring individuals to refresh/update previously completed GCP training; however, HHS, SJHH, and McMaster strongly recommend individuals consider upgrading their GCP training every 3 years, inline with other professional training requirements.

  • How do I get my certificate upon completing the Canada CITI GCP-online Certification Training?

    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.

  • How much does the Canada CITI GCP-online certification training cost?

    Hamilton Health Sciences is providing GCP Training 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 courses and tools internationally and selected a US-based CITI GCP online training system. That system was Canadianized with funding support from CIHR and a Canadian Regulatory consultant. This system is being adopted widely across Canada by N2's 200+ member organizations. It is provided to you at no cost.

  • Is there a reimbursement pool for the time we are asking investigators and research personnel to invest in completing the Canada CITI GCP-online certification training?

    No. Good Clinical Practice training is considered to be one of the essential learning elements that the HHS Executive Committee on Research (ECOR)  has determined for its investigators and applicable research personnel. GCP training fits with other annual learning and training objectives that are required in order to conduct research activity at HHS. The training program of choice (CITI Canada) 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 self-paced intervals.

  • Is the entire research team required to take GCP Training?

    Research personnel (e.g., research nurses, research coordinators, research 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.

PRIVACY issues - STOP-THINK-PROTECT

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.

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