PCR901 - Introduction to Clinical Research

Outline info
Last revision date 2018-07-20 11:48:41.976
Last review date 2018-07-20 11:48:55.716

Subject Title
Introduction to Clinical Research

Subject Description
This subject introduces students to the basic concepts in clinical research and the clinical trial regulatory environment in Canada.

Credit Status
One credit towards the Ontario College Certificate in Pharmaceutical Regulatory Affairs and Quality Operations offered through the School of Biological Sciences and Applied Chemistry and the Faculty of Continuing Education and Training.

Learning Outcomes
Upon successful completion of this subject the student will be able to:

1. Discuss the basic concepts of ethical behavoiur and ethics associated with clinical trials.

2. Discuss the drug development process.

3. Summarize the purpose of a clinical trial.

4. Assess the role and impact of the Declaration of Helsinki.

5. Apply Good Clinical Practices (GCP) to the drug development process.

6. Describe the role of a clinical research associate (CRA within a clinical research organization CRO).

7. Evaluate the management of a clinical trial site.

8. Compare clinical site monitoring and clinical site auditing.

9. Identify the requirements related to a clinical study report for marketing authorization in Canada, including the study; protocol; choice of study design; use of a control and types of control.

10. Interpret selected International Conference on Harmonization (ICH) guidelines associated with the preparation of clinical trials for a marketing authorization in Canada.

Cheating and Plagiarism
Each student should be aware of the College's policy regarding Cheating and Plagiarism. Seneca's Academic Policy will be strictly enforced.

To support academic honesty at Seneca College, all work submitted by students may be reviewed for authenticity and originality, utilizing software tools and third party services. Please visit the Academic Honesty site on http://library.senecacollege.ca for further information regarding cheating and plagiarism policies and procedures.

All students and employees have the right to study and work in an environment that is free from discrimination and/or harassment. Language or activities that defeat this objective violate the College Policy on Discrimination/Harassment and shall not be tolerated. Information and assistance are available from the Student Conduct Office at student.conduct@senecacollege.ca.

Accommodation for Students with Disabilities
The College will provide reasonable accommodation to students with disabilities in order to promote academic success. If you require accommodation, contact the Counselling and Disabilities Services Office at ext. 22900 to initiate the process for documenting, assessing and implementing your individual accommodation needs.

Co requisite
PRA700 Introduction to Pharmaceutical Regulatory Affairs

Topic Outline

  • History, background, definitions
  • Ethics
  • Good Clinical Practices;  ICH
  • Clinical study design:  types of controls, types of studies, site and subject selection
  • Clinical site management;  CROs, monitoring, auditing
  • Clinical Study Reports:  Canada
  • Good documentation practice
  • Drug safety
  • Reporting of adverse events
  • Informed Consent
  • Provincial and federal privacy rules applied to clinical research
  • Challenges related to women, children and geriatrics in clinical trials
  • Quality Assurance in clinical research
  • Health Canada regulations

Mode of Instruction

  • Participative lectures, small group discussions, directed readings and assignments
  • Guest speakers

Prescribed Texts
Subject notes can be found on the Blackboard website 

Reference Material

Required Supplies

Promotion Policy

Grading Policy
A+ 90%  to  100%
A 80%  to  89%
B+ 75%  to  79%
B 70%  to  74%
C+ 65%  to  69%
C 60%  to  64%
D+ 55%  to  59%
D 50%  to  54%
F 0%    to  49% (Not a Pass)
EXC Excellent
SAT Satisfactory
UNSAT Unsatisfactory

For further information, see a copy of the Academic Policy, available online (http://www.senecacollege.ca/academic-policy) or at Seneca's Registrar's Offices.

Modes of Evaluation

  • Assignments are due at the beginning of the class on which they are due.
  • A late penalty of 10% per day is assessed for late assignments, including those not handed in at the beginning of class when due.
  • Material will not be accepted after one week following the due date and/or when the marked material is returned to students, whichever comes first.
  • Assignments are to be prepared by computer.

Absenteeism and Exams
  • Students should be aware that absenteeism almost guarantees an inability to achieve satisfactory grades.
  • Students who are absent for an examination due to an emergency (e.g., motor vehicle accident, hospitalization or death in the family) may provide official documentation within five days of the missed exam and be provided a deferred exam at a later date.  Official documentation includes a death notice or an original doctor’s certificate identifying the date, length of time expected absence and the specific reason for the absence.  Examinations missed without official documentation and approval result in a grade of zero.
  • There are no deferred options for missed tests.  The value of missed tests, at the discretion of the Faculty, will be added to other evaluation components

English Proficiency
  • All written work should demonstrate the following characteristics for clarity and conciseness:
-writing is consistent with the rules of English grammar
-spelling and punctuation are correct
-sentences are structured correctly
-main ideas are supported with specific, relevant examples and reasons
-work flows logically through supporting statements/paragraphs
-work is arranged in correct format (e.g., as a report, essay)
-up to 10% of the final grade may be deducted on all work if the above English competencies are not met.

Format for Assignments
  • Students must use the standard, APA style for quoting sources.   Help is available at:  http://library.senecacollege.ca

Laboratory Attendance

The laboratory component is essential and therefore it is strongly recommended  that you attend all labs.  Any missed labs must be supported with a legal document with three days of the lab.  Any student who fails to attend 2 scheduled laboratory classes for a 7 week subject and more than 3 laboratory classes for a 14 week subject will not pass the subject.    

Laboratory Safety
Students are required to review and understand the safety procedures and guidelines outlined on the first class and sign the sheet to this effect before beginning work in the laboratory.  Students must also wear a lab coat and safety glasses when conducting experiments.
A student who arrives without the proper safety equipment will not be permitted to participant in the lab but will be asked to leave the class.  The student will receive no grade for the lab missed.

Grading is based on the following marking scheme:
Assignment  1 20%
Assignment 2 20%
Exam 20%
Major Project 30%
Participation 10%

Other Evaluation Considerations
The student is expected to comply with the Safety Rules for working in the laboratory, sign the safety contract, and WILL NOT UNDER ANY CIRCUMSTANCES WEAR CONTACT LENSES in the laboratory.  The student will know where all safety equipment is located in the laboratory and will be familiar with WHMIS concepts and signage.


Approved by: Denis Gravelle