PCR901 - Introduction to Clinical Research

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Last revision date Feb 12, 2019 2:32:17 PM
Last review date Mar 18, 2019 9:39:07 AM

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.

Academic Integrity
Seneca upholds a learning community that values academic integrity, honesty, fairness, trust, respect, responsibility and courage. These values enhance Seneca's commitment to deliver high-quality education and teaching excellence, while supporting a positive learning environment. Ensure that you are aware of Seneca's Academic Integrity Policy which can be found at: http://www.senecacollege.ca/about/policies/academic-integrity-policy.html Review section 2 of the policy for details regarding approaches to supporting integrity. Section 2.3 and Appendix B of the policy describe various sanctions that can be applied, if there is suspected academic misconduct (e.g., contract cheating, cheating, falsification, impersonation or plagiarism).

Please visit the Academic Integrity website http://open2.senecac.on.ca/sites/academic-integrity/for-students to understand and learn more about how to prepare and submit work so that it supports academic integrity, and to avoid academic misconduct.

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 Accessibility Services Office at ext. 22900 to initiate the process for documenting, assessing and implementing your individual accommodation needs.