PCR901 - Introduction to Clinical Research

Outline information
Semester
Schools offering this subject
Last revision date 2017-05-29 00:25:11.916
Last review date 2017-07-17 00:16:28.936

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.

Discrimination/Harassment
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.