Humber
SEARCH
2012-13 Full-Time Programs
  • Increase
  • Normal
  • Decrease

Current Size: 100%

PROGRAM SEARCH


Clinical Research
HOW TO APPLY
Print | Share

School of Health Sciences

2012/2013 Program Availability

North
Fall:
Open
Type:
Ontario Graduate Certificate
Postgraduate
Campus: North
Program Code:
07681
Length:

Three semesters, beginning in September
CONTACT INFORMATION:
Program assistant | 416.675.6622 ext. 4341 | clinical.regulatory@humber.ca
  • Our Program

    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.
     

  • Your Career

    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.
     

  • Workplacement

    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.
     

  • Admission Requirement
    • A Bachelor of Science degree, majoring in Health Science, Pharmacy, some areas in Life Sciences or a related field. Internationally-educated individuals must have the equivalent of a Canadian Bachelor of Science degree. Degrees completed outside of Canada must be evaluated by one of the following: International Credential Assessment Service, University of Toronto Comparative Education Service or World Education Service
    • Testing in English writing skills and reading comprehension
    • Additionally, applicants must submit a detailed resumé describing their background (academic and experience), and cover letter outlining their understanding of the field of clinical research and what they would bring to the field
    • Applicants are ranked based on the testing results and the best qualified are invited in for an interview/information session where the final selection is made for admission into the program

    Note: For more information visit Selection Procedures.

    Meeting the minimum requirements does not guarantee admission to the program.

  • Fees

    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.

Curriculum

  • Semester 1

    Course CodeCourseCredits
    BIOS 502Anatomy and Physiology for Clinical Research

    Anatomy and Physiology for Clinical Research

    Course 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 503Pathophysiology for Clinical Research

    Pathophysiology for Clinical Research

    Course 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 500Introduction to Clinical Research and Product Development

    Introduction to Clinical Research and Product Development

    Course Code: CLIN 500
    Credits: 2
    		2
    CLIN 502Regulations, Guidelines and Standards Governing Clinical Research

    Regulations, Guidelines and Standards Governing Clinical Research

    Course 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 505Interpersonal and Negotiation Skills for Clinical Research

    Interpersonal and Negotiation Skills for Clinical Research

    Course 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 509Clinical Laboratory Procedures and Data Interpretation

    Clinical Laboratory Procedures and Data Interpretation

    Course 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 510Scientific and Technical Writing

    Scientific and Technical Writing

    Course 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 513Biotechnology

    Biotechnology

    Course 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 514Recent Trends in Therapeutics

    Recent Trends in Therapeutics

    Course 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 CodeCourseCredits
    CLIN 503Organization and Monitoring of Clinical Trials

    Organization and Monitoring of Clinical Trials

    Course 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 504Data Collection Techniques and Biostatistical Methods for Clinical Research

    Data Collection Techniques and Biostatistical Methods for Clinical Research

    Course 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 506Investigational Materials; Planning, Handling and Disposition

    Investigational Materials; Planning, Handling and Disposition

    Course 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 507Development of Protocols and Case Report Forms

    Development of Protocols and Case Report Forms

    Course 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 508Clinical Trials in Specific Diseases

    Clinical Trials in Specific Diseases

    Course 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 511Clinical Project Management

    Clinical Project Management

    Course 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 512Medical Devices

    Medical Devices

    Course 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 CodeCourseCredits
    CLIN 515Work Experience

    Work Experience

    Course 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 516Integrative Seminar

    Integrative Seminar

    Course 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