Learn more about the academic programs we are delivering in Summer 2024. If you have any questions about part-time studies, please contact us.
In this graduate certificate program, you will learn research design concepts, analysis and the quality assurance required for daily operations in the clinical research field. You will examine clinical studies across the pharmaceutical, medical device and natural health product sectors that give the competitive edge required in this dynamic industry. In this hands-on program, you will work alongside industry professionals and develop a network of contacts ahead of graduation.
Students are invited to attend an information session.
When you graduate from this program, these are the types of career options that you can explore:
Admission Requirements
It is your responsibility to ensure that program requirements and course prerequisites as outlined are met. Prerequisites are included for your academic protection. Knowledge of the prerequisite material is assumed by your instructor and instruction will proceed accordingly. Students lacking prerequisites not only jeopardize their own ability to succeed but present unnecessary interruption. If you lack appropriate prerequisites (or Transfer Credit for the prerequisite course) you may be asked to withdraw or transfer to a more appropriate course with the risk of academic/financial penalty.
If you are interested in applying to the Clinical Research graduate certificate program, please review the following information and submit documents to melanie.rubens@senecapolytechnic.ca.
Part-time Studies courses are being offered in either of the following four formats: Online, Flexible, In-person, Hybrid. Click Availability below to see current offerings.
This course provides an overview of the regulatory framework for the conduct of clinical trials. Topics include the role of regulatory agencies in the approval of new drugs/devices, relevant clinical trial regulations, the clinical trial application process and an evaluation of global healthcare systems as a factor in the conduct of clinical trials.
This course provides an overview of the entire drug discovery and development process, from the considerations that goes into deciding which drugs to develop to the final stages of clinical trials. The key concepts are covered and defined. Students will gain insight into the steps undertaken to bring a new drug to development.
This course provides an overview of the management and conduct of clinical trials and the staff involved in conducting clinical trial research. Topics include essential documents in the clinical trial, the need for SOPs and qualified staff and process for adequate oversight of the clinical trial.
A clinical trial is a carefully planned and scientifically sound experiment. This course provides students with an opportunity to learn and understand the rationale of designing, conducting and successfully completing a clinical trial. Students gain understanding of drug action, metabolism and clearance.
This course provides an overview of the fundamentals of ICH E6: Good Clinical Practice and highlights the importance of this guidance in ensuring consistency and safety of participants partaking in drug trials. The importance of the ethics in conducting clinical research will also be discussed.
This subject focuses on the concept of Quality Assurance/Quality Control, planning and contribution of the Quality Assurance team in an organization. Topics covered include: QA/QC theory; documentation for GMPs; SOP theory, writing & reviewing; auditing theory; deviation management and CAPA; complaint-handling; and training on GLPs, GMPs and the International Quality Standards. Students gain significant hands on experience in document reviewing and SOP writing/reviewing as well as case study work in process deviation and Change Control processes. These skills were intentionally built into the program to provide students with meaningful QA skills that can be applied to their employment activities without a large training investment on behalf of the company who accepts them.
TWC 714 is a post-diploma writing and communication course for students in the Clinical Research program. Students will be exposed to various documents pertinent to the Clinical Research field including composing responses to Health Canada Clarification letters and other Notices specific to the CR profession. Students will also apply protocols and best practices in writing and speaking that expedite clinical trials and other related steps and phases of the approval and submission process; participate in a CR-specific career interview that forms the basis for a short report; apply theory and practice in effective interpersonal skills, leadership, group problem solving and conflict-resolution; conduct scholarly research on a current trend in Clinical Research; deliver the research in an effective presentation that combines verbal clarity, simplicity, and eloquence with effective visuals. Students will also gain experience with the protocols of formal meetings, including exposure to Robert's Rules of Order. Emphasis throughout this course will be placed on the underlying rules and standards of effective written and oral communication in Clinical Research.
This subject outlines the various milestones of clinical research in relation to monitoring of the clinical site. The subject defines the sponsor's and investigator's perspective and expectations in clinical research. Students gain the knowledge to ensure the study site processes and procedures are compliant and that data collected meets quality standards. Students learn the overall management and organization key elements required to monitor a study effectively
In this course students develop a clinical trial protocol including a plan for training, monitoring and data management. Concepts including grant writing, literature reviews, communication skills and data interpretation will be covered. Students develop clinical trial documents including informed consent documents and case report forms for each study visit. Teams of students prepare presentations for lay and scientific audiences.
Students will build upon the quality concepts taught in Introduction to Clinical Quality Assurance to delve further into quality issues. The ability to critically analyze clinical data will be explored.
All Module 1 courses must be completed prior to registering into Module 2.
Upon successful completion of this program, graduates are able to:
Earn college credits for what you already know.
Prior Learning Assessment is a method of assessing and recognizing learning that is equal to
college level learning, but has been gained outside a traditional classroom (through work
experience, volunteering, outside study, etc.). If you can prove that the knowledge you have gained
meets the outcomes of a Seneca course, then credit will be awarded.
How does the PLA process work?
Prior Learning is demonstrated through a "challenge" process. The process measures learning
through a variety of methods which may include tests, portfolio assessment, interviews,
demonstrations, essays, and work samples. The method used will be determined in consultation with a
Program Coordinator.
For more information and to determine if you are eligible for PLA, please call the Program
Coordinator.
The process may take from 6 to 8 weeks.
Note: Not all courses can be challenged. For more information go to PLA website or contact your Program Coordinator.
Many students who enter Seneca Polytechnic will have earned academic credits in post-secondary educational institutions which they may be able to apply toward completion of a Seneca College program.
Requests for Transfer Credit must be for a specific course and must be accompanied by an official transcript and course outline. A minimum grade of "C" (60 percent) is generally required for a course to be considered for Transfer Credit.
Download a Transfer Credit Request form. An official copy of your transcript and applicable detailed course outlines should be attached and submitted. Please note it may take 4 to 6 weeks for a Transfer Credit decision.
Please visit the Office of the Registrar.
Take your graduate certificate further
Seneca is recognized as a leader in pathways and offers a range of options to help you reach your educational and career goals.
As a graduate of this program, you may be eligible to pathway into a master's degree program at one of our partner institutions.
To qualify for a master's degree program, you may require a bachelor's degree as a prerequisite. Visit our Degree Transfer Guide to learn more and explore your pathway options.
If you have additional questions regarding pathways to, within and beyond Seneca, connect with our Academic Pathways team at 416.764.0399 or email academic.pathways@senecapolytechnic.ca.
After reviewing the Degree Transfer Guide, you can also book a virtual appointment to discuss your options in more detail with a dedicated Pathways Adviser.
When you meet all program requirements and become eligible for a certificate, diploma, or degree, you must inform the Registrar by completing a Graduation Application form and paying the graduation and alumni fee. Certificates, diplomas, and applied degrees are issued twice a year in the Fall (October), Spring (June) and Winter (February).
For further information including deadlines and fees, please visit the Convocation website or contact the Convocation Office at theservicehub@senecapolytechnic.ca.
A student will be eligible to graduate from a certificate, diploma, advanced diploma or graduate certificate program if they have achieved a minimum graduating GPA of 2.0.
A student will be eligible to graduate from a degree program if they have achieved a minimum graduating GPA of 2.5, which includes a minimum GPA of 2.5 in the courses in their main field of study and a minimum GPA of 2.0 in breadth courses.
A faculty of Seneca College may recommended a student for a certificate, diploma or degree only after the student has earned a minimum of twenty-five percent of the credit for that program at Seneca.
Maria Graziosi
Program Assistant
Maria.Graziosi@senecapolytechnic.ca
416-764-0964
Melanie Rubens
Program Coordinator
Melanie.Rubens@senecapolytechnic.ca
416-764-0973
Students are invited to attend an information session.