CRP100 - Clinical Trial Regulations
| Semester | |
| School | |
| Last revision date | Jan 26, 2026 1:34:18 AM |
| Last review date | Mar 16, 2026 12:15:22 AM |
Subject Title
Clinical Trial Regulations
Subject Description
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.
Credit Status
One credit toward the Clinical Research Certificate Program
Learning Outcomes
Upon successful completion of this subject the student will be able to:
1. Examine the organization of regulatory agencies and their role in the approval of new medications, medical devices
2. Demonstrate a general understanding of regulations and guidelines required to conduct clinical trials
3. Describe the clinical trials application process
4. Demonstrate an understanding of requirements for clinical trials by different regulatory agencies in different jurisdictions.
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.senecapolytechnic.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.
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@senecapolytechnic.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.
Camera Use and Recordings - Synchronous (Live) Classes
Synchronous (live) classes may be delivered in person, in a Flexible Learning space, or online through a Seneca web conferencing platform such as MS Teams or Zoom. Flexible Learning spaces are equipped with cameras, microphones, monitors and speakers that capture and stream instructor and student interactions, providing an in-person experience for students choosing to study online.
Students joining a live class online may be required to have a working camera in order to participate, or for certain activities (e.g. group work, assessments), and high-speed broadband access (e.g. Cable, DSL) is highly recommended. In the event students encounter circumstances that impact their ability to join the platform with their camera on, they should reach out to the professor to discuss. Live classes may be recorded and made available to students to support access to course content and promote student learning and success.
By attending live classes, students are consenting to the collection and use of their personal information for the purposes of administering the class and associated coursework. To learn more about Seneca's privacy practices, visit Privacy Notice.
Prerequisite(s)
None
Topic Outline
Unit 1 Introduction to Canadian Health Care System. Health Care System in USA, EU and Japan
Unit 2 Introduction to Health Canada and its role in the New Drugs Approval
Unit 3 Introduction to the Food and Drugs Act and Regulations, Division 5 of the FDA
Unit 4 Organization, Regulations on Clinical Trials in the USA
Unit 5 Introduction to ICH and Documents Relevant to Clinical Trials
Unit 6 Clinical Trials Application and Investigational New Drug Application, CTA and INDA for drugs and biologics
Unit 7 Clinical Trials Inspection, Investigation, Audit – Health Canada Requirements – GMP
Unit 8 Clinical Trials for NHPs
Unit 9 Clinical Trials for Medical Devices
Unit 10 Clinical Trials Regulations in EU and Japan
Unit 11 Health Care System and Clinical Trials Regulations in India and China
Unit 12 Clinical Trials Regulations in Latin America
Unit 13 Common Technical Document, NDS and NDA
Mode of Instruction
Lectures, group work, in-class exercises, assignments. Students can expect to spend approx. 2-3 hours outside of class reading, doing assignments, etc.
Prescribed Texts
None
To find out the cost of books and learning material go here.
Any courses not listed on the bookstore webpage do not require any resources for purchase. All resources will be provided by your instructor.
Reference Material
Subject notes can be found on the Blackboard website
Food and Drugs Act : http://laws-lois.justice.gc.ca/eng/acts/f-27/
Food and Drug Regulations: http://laws-lois.justice.gc.ca/eng/regulations/C.R.C.,_c._870/
Required Supplies
None
Student Progression and Promotion Policy
http://www.senecapolytechnic.ca/about/policies/student-progression-and-promotion-policy.html
Grading Policyhttp://www.senecapolytechnic.ca/about/policies/grading-policy.html
| 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) |
| OR | |
| EXC | Excellent |
| SAT | Satisfactory |
| UNSAT | Unsatisfactory |
For further information, see a copy of the Academic Policy, available online (http://www.senecapolytechnic.ca/about/policies/academics-and-student-services.html) or at Seneca's Registrar's Offices. (https://www.senecapolytechnic.ca/registrar.html).
Modes of Evaluation
Assignments
- 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:
-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.senecapolytechnic.ca
LAB COURSES
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:
| Assignments | 30% |
| Presentations | 10% |
| In-Class Exercises | 30% |
| Final Exam | 30% |
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.
PLEASE RETAIN THIS SUBJECT OUTLINE FOR POSSIBLE FUTURE USE IN SUPPORT OF CREDIT APPLICATIONS AT OTHER EDUCATIONAL INSTITUTIONS