Current Size: 100%
Clinical Research |
School of Health Sciences |
2012/2013 Program AvailabilityNorth Fall: Open |
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Type:
Ontario Graduate Certificate Postgraduate
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Campus:
North
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Program Code:
07681 |
Length: Three semesters, beginning in September |
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CONTACT INFORMATION: Program assistant | 416.675.6622 ext. 4341 | clinical.regulatory@humber.ca
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Humber’s Clinical Research program has an international focus, because most companies conduct international clinical trials and additionally, current clinical processes in most countries are based on International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidelines. In addition to international guidelines, students will gain understanding of Canadian and other jurisdictions allowing them to become competitive in the marketplace worldwide. Program courses include the drug development process; regulations, guidelines and standards; research methodology and biostatistics; clinical trial organization, monitoring and documentation; and project management. The Clinical Research program is also offered in a part-time format, however, the part-time program does not include the internship component.
This program is unique in offering in-depth, hands-on learning provided by faculty currently employed in the clinical research industry. The program’s Advisory Committee provides constant feedback regarding program development. The program has a very high reputation among employers and therefore graduates of the program experience high employment rate.
This postgraduate program focuses on developing the concepts, skills and techniques required to work in the clinical research conducted in hospitals, and in the pharmaceutical, medical device or biotechnology industry. Students will acquire knowledge about design, administration and management of clinical trials, which are experimental studies conducted on human beings, testing new drugs, devices and other health products or interventions to safely introduce these on the market.
Graduates of Humber’s Clinical Research program have gone on to work for Apotex, AstraZeneca, Bayer, GSK, Health Canada, Janssen-Ortho, MDS, Princess Margaret Hospital, Sanofi, University Health Network and many others. The typical positions after completion of the program were: clinical research associate (CRA), clinical research co-ordinator (CRC), monitor, medical writer, pharmcovigilance specialist, clinical project management assistant and many others.
Students must complete a three-month placement that provides an opportunity to apply and integrate their knowledge and skills in a real-world work setting. Most placements are in the following sectors: pharmaceutical, biotechnology, medical devices industry, government and hospitals.
Note: For more information visit Selection Procedures.
Meeting the minimum requirements does not guarantee admission to the program.
For additional information regarding our full-time program, visit
healthsciences.humber.ca/programs.
For information regarding our part-time program, visit humber.ca/continuingeducation.
The 2011/2012 fee for three semesters was
– domestic $5,900.74
– international $12,200.
Amounts listed are the total of tuition, lab and material fees, student service and auxiliary fees for the first three semesters of the 2011/2012 academic year.
Fees are subject to change.
For further information, refer to Fees and Financial Assistance in this publication.
Semester 1 | ||
| Course Code | Course | Credits |
| BIOS 502 | Anatomy and Physiology for Clinical ResearchAnatomy and Physiology for Clinical ResearchCourse Code: BIOS 502 Credits: 2 This course is designed to cover the structure and function of the human body with special emphasis on physiological concepts. Students will become familiar with the nervous, endocrine, cardiovascular, respiratory, digestive, urinary and reproduction systems as well as fluid/electrolyte and acid/base balance. | 2 |
| BIOS 503 | Pathophysiology for Clinical ResearchPathophysiology for Clinical ResearchCourse Code: BIOS 503 Credits: 3 This intense course will introduce students to the subject of pathophysiology. The students will study about different diseases, their etiology, epidemiology, symptoms, and other abnormalities associated with these diseases. The emphasis will be on diagnosis in relation to endpoints used in clinical research. | 3 |
| CLIN 500 | Introduction to Clinical Research and Product DevelopmentIntroduction to Clinical Research and Product DevelopmentCourse Code: CLIN 500 Credits: 2 | 2 |
| CLIN 502 | Regulations, Guidelines and Standards Governing Clinical ResearchRegulations, Guidelines and Standards Governing Clinical ResearchCourse Code: CLIN 502 Credits: 3 This course is designed to provide a framework for understanding the standards and regulations that affect the conduct of clinical trials. The course will starts with a historical overview of such documents as the Nuremberg Code, the Belmont Report and The Declaration of Helsinki. Emphasis will be on the International Conference on Harmonization (ICH) guidelines, which will include GCP, reporting of adverse reactions and trials in special populations. Additionally, such topics as the Tri-Council Policy Statement, the Food and Drugs Act, the SAP program and privacy legislation will be discussed. | 3 |
| CLIN 505 | Interpersonal and Negotiation Skills for Clinical ResearchInterpersonal and Negotiation Skills for Clinical ResearchCourse Code: CLIN 505 Credits: 1 This course focuses on the clinical research context for interpersonal transactions. Students will enhance their interpersonal communication skills by developing active listening and interviewing skills. Understanding of personal effectiveness, organizational and conflict resolution strategies will assist students. In developing skills in the use of collaborative and problem-solving approaches in professional relationships. An understanding of personal strengths and weaknesses will help the student to set up personal goals. | 1 |
| CLIN 509 | Clinical Laboratory Procedures and Data InterpretationClinical Laboratory Procedures and Data InterpretationCourse Code: CLIN 509 Credits: 2 This course will provide detailed knowledge on the application and relevance of laboratory values in clinical research. The students will learn about laboratory methods, about false positive and false negative outcomes and their interpretations. The emphasis will be on interpretation of the results in relation to different disease states. | 2 |
| CLIN 510 | Scientific and Technical WritingScientific and Technical WritingCourse Code: CLIN 510 Credits: 1 This course is designed to enhance the writing, editing, and comprehension strategies of students for whom writing is an important function in their employment. The goal of this course is to provide some of the tools that students need to continue improving their own writing. Students will focus on writing skills, including grammar elements and spelling, and will practice editing, organizing, and summarizing scientific documents, as well as becoming familiar with different types of internal and external business communications. | 1 |
| CLIN 513 | BiotechnologyBiotechnologyCourse Code: CLIN 513 Credits: 2 This course is designed to provide students with the basic concept in biotechnology with a focus on medical biotechnology. The course comprises of 14 lectures that cover a broad range of topics on products and technologies used for human health or the health-care system. Central to the study of biotechnology is an understanding of the basic concepts in molecular genetics, protein chemistry, microbiology and immunology. The students will learn about recombinant DNA technology and genomics, which has application in drug development, pharmacogenomics, DNA-based diagnosis of genetic diseases and in human gene therapy. Also, students will learn the concepts underlying the innate and adaptive immunity, which has application in the development of vaccines for infectious diseases, in oncology, and transplantation. Some lectures will review current medical products and applications of biotechnology and will present a brief background of the growth and future potential of biotechnology products. Current regulatory framework governing this industry in different countries will be explored by visiting related websites. | 2 |
| CLIN 514 | Recent Trends in TherapeuticsRecent Trends in TherapeuticsCourse Code: CLIN 514 Credits: 4 This course is designed to introduce the students to the fundamentals of pharmacology. It will focus on the relationship between a drugs mechanism of action at the molecular level and its effect on the patient. Course material will balance both basic and clinical aspects of drug action, with the goal of providing the students with a fundamental understanding of the field of pharmacology. The general principles of pharmacokinetics and pharmacodynamics will be introduced and students will examine various body systems such as the anatomic and central nervous systems, and the cardiovascular, respiratory, renal, blood, endocrine and gastrointestinal systems. Additionally, anti-infective chemotherapeutic agents and various mediators of tissue responses will be discussed. A prior knowledge of basic physiology, anatomy and biochemistry is recommended to fully appreciate the topics discussed in this course. | 4 |
Semester 2 | Course Code | Course | Credits |
| CLIN 503 | Organization and Monitoring of Clinical TrialsOrganization and Monitoring of Clinical TrialsCourse Code: CLIN 503 Credits: 3 This course is designed to outline the various stages of clinical research as they relate to the investigative site. The course will review the progress of a study from an investigator's as well as a sponsor's perspective and highlight the milestones reached throughout the study. Students will learn the management and organizational aspects of site monitoring combined with the quality control measures that ensure the collection of adequate data. | 3 |
| CLIN 504 | Data Collection Techniques and Biostatistical Methods for Clinical ResearchData Collection Techniques and Biostatistical Methods for Clinical ResearchCourse Code: CLIN 504 Credits: 3 This course will provide an introduction to the biostatistical concepts and methods required in the development of a clinical trial and the analysis and interpretation of clinical trial data. This course will also provide an overview of methods available for the collection of clinical trial data, such as paper-based methods, fax-based methods, and remote data-entry methods. | 3 |
| CLIN 506 | Investigational Materials; Planning, Handling and DispositionInvestigational Materials; Planning, Handling and DispositionCourse Code: CLIN 506 Credits: 1 This course is designed to ensure that students are aware of the practices, issues and concerns with regard to the handling of investigational materials used in clinical trials. Students will be introduced to common practices and guidelines for the safe and effective handling of these materials. | 1 |
| CLIN 507 | Development of Protocols and Case Report FormsDevelopment of Protocols and Case Report FormsCourse Code: CLIN 507 Credits: 2 This course will guide student through the requirements of effective protocol and report form development. Students will understand the elements of effective protocols. Case studies will be examined to highlight practical issues and concerns. | 2 |
| CLIN 508 | Clinical Trials in Specific DiseasesClinical Trials in Specific DiseasesCourse Code: CLIN 508 Credits: 4 This course will provide students with an opportunity to explore some of the special considerations and techniques applicable to clinical trials in various therapeutic areas and disease states. Guest speakers with a focus on particular areas of research will outline the current status of drug development and treatment modalities in their respective areas. The course will include a team project where students will select, investigate and report on current research activity and methodological issues in a therapeutic area of interest. | 4 |
| CLIN 511 | Clinical Project ManagementClinical Project ManagementCourse Code: CLIN 511 Credits: 3 This course has been designed to introduce students to the principles and practice of project management as a common approach to structuring work in the pharmaceutical and biotechnology industries. The course will emphasize skills, attitudes and values necessary to be a contributor in the workplace of both big pharma and smaller Canadian biotech companies, as well as in hospital setting. | 3 |
| CLIN 512 | Medical DevicesMedical DevicesCourse Code: CLIN 512 Credits: 1 This course will focus on medical devices with all relevant aspects starting from definition of medical device to mechanism of surveillance of marketed medical devices. The students will learn a process of applying for licences for medical devices, obtaining certifications, submitting annual notifications, etc. Specific regulatory requirements for medical devices manufactured in Canada, US, European Union countries and others will be discussed. Additionally students will review Canadian Medical Devices Conformity Assessment System. | 1 |
Semester 3 | Course Code | Course | Credits |
| CLIN 515 | Work ExperienceWork ExperienceCourse Code: CLIN 515 Credits: 4 The students are expected to find and complete an internship in the clinical research area in the health care industry such as pharmaceutical, medical device or biotechnology companies; hospitals; government, etc. The internship will allow you to apply in a real-world work setting, the clinical research skills and knowledge acquired during the first two semesters. | 4 |
| CLIN 516 | Integrative SeminarIntegrative SeminarCourse Code: CLIN 516 Credits: 1 The students are expected to find and complete an internship in the clinical research area in the health care industry such as pharmaceutical, medical device or biotechnology companies; hospitals; government, etc. The internship will allow you to apply in a real-world work setting, the clinical research skills and knowledge acquired during the first two semesters. | 1 |