As a clinical research associate at one of Canada's largest learning and research hospitals, I am involved with all phases of clinical research at the site level, from literature reviews and protocol development to study close-out procedures. I manage several clinical trials concurrently, with responsibilities including patient screening, consent, recruitment, follow-up, data collection, data entry and safety monitoring. I am involved in planning, developing and implementing research study protocols, including proper patient recruitment strategies, and appropriate methods for follow-up and data collection. Additionally, I am responsible for identifying funding opportunities and writing, reviewing and submitting grant applications.
On this page, I have included professional resources relevant to the field of clinical research.
FUNDING AGENCIES
Clinical research trials can be expensive. The cost varies widely depending on the nature and size of the study. Examples of some of the costs incurred are for research staff time, medical imaging (x-rays, CT scans, MRI), pharmacy services, ethics board fees, questionnaire licenses, and participant payments. In some cases, pharmaceutical companies will develop a protocol to research their drug or device. These are known as industry-funded studies, and the pharmaceutical company will pay recruiting sites for their time and fees. In other cases, investigators (physician-scientists) will research a topic and develop their own protocols. These are known as investigator-initiated studies. When funding is required to carry out these studies, investigators will often seek out grant opportunities. Grants are offered by both public and private agencies. Below I have included resources to some of the largest public granting agencies in Canada.
The Canadian Institute of Health Research (CIHR) is Canada's federal funding agency for health research. CIHR grants approximately $1 billion annually to over 13, 000 world-class researchers from all pillars of health research and from all regions of Canada.
The Network of Centres of Excellence of Canada (NCE) brings together diverse scientific fields, industry sectors, and public and local partners, establishing comprehensive knowledge, to develop, test and evaluate proven solutions. The NCE is a federal government organization that funds a wide array of research with the overall goal of knowledge mobilization.
The mission of the Orthopedic Trauma Association (OTA) is to promote excellence in care for the injured patient, through provision of scientific forums and support of musculoskeletal research and education of Orthopaedic Surgeons and the public. The OTA has awarded over $11.5 million to over 400 research projects since its inception in 1990.
TRAINING & EDUCATION
In order to partake in clinic research, staff and investigators are required to complete training activities and hold specific certifications. The training required to run research studies varies depending on the nature and complexity of the study and the responsibilities held. Some courses are nationally and internationally recognized and required by law, and others are specific to the research institute (such as standard operating procedures). Additionally, specific training is required on each study protocol. Below, I have included references to the most common training certifications.
The Collaborative Institutional Training Initiative is the trusted standard for research, ethics, and compliance training. The Good Clinical Practice and Health Canada Division 5 – Drugs for Clinical Trials Involving Human Subjects are courses required to complete some of the clinical research I coordinate.
The N2 Netowrk of Networks (N2) is an alliance of Canadian research networks and organizations working to enhance national clinical research capability and capacity. The N2 has developed standard operating procedures for research institutions, allowing for standardization between research institutions.
The Panel on Research Ethics is designed to promote the ethical conduct of research involving human participants in Canada. The Panel designed the Tri-Council Policy Statement 2 training, which is required by all individuals involved in conducting human research activities.
CLINICAL RESEARCH ASSOCIATIONS
Professional associations in clinical research are designed to promote excellence and integrity in clinical trials. These associations often involve a membership fee, certification opportunities, and continued learning seminars.
The Society of Clinical Research Associates (SOCRA) is committed to providing education, certification, and networking opportunities to all persons involved in clinical research activities. SOCRA developed a certification program to create an internationally-accepted standard of knowledge, education, and experience for clinical research professionals, known as the Certified Clinical Research Professional Certification.
The Association of Clinical Research Professionals (ACRP) supports clinical research professionals through membership, training and development, and certification. The ACRP offers certifications for all roles in clinical research, including associates, coordinators, investigators, and professionals.