Registration for Fall 2026 programs and courses is now open. Learn more about the academic programs we are delivering in Fall 2026. If you have any questions about part-time studies, please contact us.

Clinical Research

Ontario College Graduate Certificate

Core Information


 

Overview

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.

Important Information for New and Returning Students

You can enrol in courses that are part of this program as a declared or undeclared student. Program declaration is the process of identifying the program you plan to complete and graduate with.

Declared Students

Declaring your program helps ensure your academic record accurately reflects your educational goals and supports your academic progression toward a credential.

By declaring your program, you'll be able to:

  • Get priority access when enrolling in classes and have the best chance to build your ideal schedule by selecting from a variety of options, which could include day, evening and weekend classes.
  • Plan your course schedule with confidence by understanding your program requirements and next steps.
  • Access enhanced advising and academic supports tailored to your goals.
  • Track your progress and benefit from a smooth path to graduation. Undeclared students without tracked academic progression may experience delays when it comes time to graduate and attend Convocation.

Undeclared Students

If you have not declared a program, Seneca may not know which credential you are working toward. As a result, you may miss out on the important benefits that declared students receive. You can remain undeclared and continue registering for courses if you do not intend to complete a credential and do not require progress tracking, enhanced advising support or Convocation eligibility.

New Students

Declared Students: For details about the program and how to apply as a declared student, please visit Seneca's updated Clinical Research page.

Undeclared Students: Register for courses by visiting the curriculum tab to select your course(s), check out and pay using this website.

Returning Students

Declared Students: Course registration for the Winter 2027 term for the part-time Clinical Research program will move from this website to Seneca's Visual Schedule Builder (VSB) platform. You will be able to build your class schedule when open enrolment begins on Dec. 10, 2026. Watch your email for instructions.

Undeclared Students: Register for courses by visiting the curriculum tab to select your course of interest, check out and pay using this website.

If you haven't yet declared your program but wish to do so, more information will be available soon.

Curriculum

Please review "Important Information for New and Returning Students" on the overview tab before registering for courses.

 

Important: The curriculum for this program has changed as of the Fall 2026 Term. Please review the new curriculum below to confirm your courses, progression and graduation requirements before registering. For questions, contact theservicehub@senecapolytechnic.ca.

Students who completed CRP109 Clinical Research Data Management will not be required to complete CRP116 Clinical Research Data Management or CRP117 Statistics for Clinical Research.

Students who completed CRP113 Good Clinical Practice and Ethics will not be required to complete CRP114 GCP - Good Clinical Practice or CRP115 Ethics of Clinical Study Administration.

Clinical Research

Semester 1

CRP100
Clinical Trial Regulations
Availability
 

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.

Ancillary Fees

Ancillary fees will be added at checkout for program-based courses. Fees will vary based on the number of course registrations. Learn more about ancillary fees for part-time studies.




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CRP101
Introduction to Drug Development/Clinical Trials
Availability
 

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.

Ancillary Fees

Ancillary fees will be added at checkout for program-based courses. Fees will vary based on the number of course registrations. Learn more about ancillary fees for part-time studies.




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CRP104
Clinical Study Administration
Availability
 

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.

 

Ancillary Fees

Ancillary fees will be added at checkout for program-based courses. Fees will vary based on the number of course registrations. Learn more about ancillary fees for part-time studies.




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CRP108
Clinical Trial Design and Pharmacology
Availability
 

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.

Ancillary Fees

Ancillary fees will be added at checkout for program-based courses. Fees will vary based on the number of course registrations. Learn more about ancillary fees for part-time studies.




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CRP114
GCP - Good Clinical Practice
Availability
 

Ancillary Fees

Ancillary fees will be added at checkout for program-based courses. Fees will vary based on the number of course registrations. Learn more about ancillary fees for part-time studies.




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PQA712
Introduction to Clinical Quality Assurance
Availability
 

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.

Ancillary Fees

Ancillary fees will be added at checkout for program-based courses. Fees will vary based on the number of course registrations. Learn more about ancillary fees for part-time studies.




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TWC714
Technical Writing and Communication I - Clinical Research
Availability
 

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.

Ancillary Fees

Ancillary fees will be added at checkout for program-based courses. Fees will vary based on the number of course registrations. Learn more about ancillary fees for part-time studies.




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Semester 2

CRP106
Monitoring Clinical Research
Availability
 

Prerequisite(s):

CRP100 and CRP101

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

Ancillary Fees

Ancillary fees will be added at checkout for program-based courses. Fees will vary based on the number of course registrations. Learn more about ancillary fees for part-time studies.




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CRP110
Medical Writing and Clinical Research Project
Availability
 

Prerequisite(s):

CRP100, CRP101, CRP104, CRP108, CRP113, PQA712 and TWC714

Corequisite(s):

CRP106

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.

Ancillary Fees

Ancillary fees will be added at checkout for program-based courses. Fees will vary based on the number of course registrations. Learn more about ancillary fees for part-time studies.




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CRP112
Clinical Auditing and Critical Analysis
Availability
 

Prerequisite(s):

PQA712

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.

Ancillary Fees

Ancillary fees will be added at checkout for program-based courses. Fees will vary based on the number of course registrations. Learn more about ancillary fees for part-time studies.




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CRP115
Ethics of Clinical Research
Availability
 

Ancillary Fees

Ancillary fees will be added at checkout for program-based courses. Fees will vary based on the number of course registrations. Learn more about ancillary fees for part-time studies.




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CRP116
Clinical Research Data Management
Availability
 

Ancillary Fees

Ancillary fees will be added at checkout for program-based courses. Fees will vary based on the number of course registrations. Learn more about ancillary fees for part-time studies.




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CRP117
Statistics for Clincal Research
Availability
 

Ancillary Fees

Ancillary fees will be added at checkout for program-based courses. Fees will vary based on the number of course registrations. Learn more about ancillary fees for part-time studies.




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