FAQs – MSc in Clinical Trials and Regulatory Affairs
Below are several frequently asked questions about the admissions and application process for the MSc in Clinical Trials and Regulatory Affairs. If you have any questions that aren’t covered below, please don’t hesitate to contact the department at clinicaltrials@cunet.carleton.ca.
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This program is designed for science graduates and healthcare professionals who wish to pursue and/or advance their careers in clinical trials and regulatory affairs. Graduates will be well-prepared for clinical research and regulatory affairs, with the skills to meet the demands of healthcare research.
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Clinical trials are an essential component of healthcare research and mark a crucial step in the development of new medical treatments. These studies involve human participants and assess the safety and efficacy of therapeutic interventions.
Clinical trials are typically conducted in a series of 4 phases, each focusing on a different research question:
- Phase I trials: The treatment is often tested in healthy participants to identify dosage, toxicity, safety, and pharmacokinetics. The treatment may also be tested on a small group of participants with disease to study the safety and doses of the treatment and to identify side effects (e.g., in cancer).
- Phase II trials: The treatment is tested on a larger group of participants with disease to further study its safety and determine its effectiveness.
- Phase III trials: The treatment is tested on an even larger group of people to monitor side effects and confirm its effectiveness. The new treatment is compared to the standard treatment or other similar treatments.
- Phase IV trials: These trials are conducted following approval of the treatment and consist of monitoring the treatment’s safety and effectiveness in the general population.
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Regulatory affairs involve all the regulations and policy programs governing the submissions and approvals of therapeutic interventions. Regulatory affairs ensure that approved products comply with applicable legislative and regulatory standards.
Regulations provide a legal framework to support the implementation of new laws and are enforceable by law. While legislation is adopted by the Parliament, regulations are adopted by administrative bodies to which authority has been given by the Parliament.
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The practicum consists of a 4-month placement at an external organization in the community, such as research institutes, government agencies, pharmaceutical companies, and contract research organizations (CROs). Occurring following coursework completion, the practicum allows students to gain practical expertise by applying knowledge and skills provided through the program to the real-world work setting. By devoting 30 hours per week for 13 weeks, students accumulate a total of 390 hours of experiential learning from the practicum.
A list of practicum opportunities is sent to students early during the program. Students will meet with the program coordinator to discuss their interests and potential practicum sites. Typically, interviews will be set up between students and their potential practicum sites.
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No – This is not a requirement. However, this would be considered as an asset to your application.
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No – Since this is a course-based program, students will not require nor be assigned a supervisor.
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If students already have a particular placement in mind, students are encouraged to bring forward their suggestions to the program coordinator. However, this is not required. Students accepted into the program will meet with the program coordinator to find a placement.
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Applications are submitted online
- Once an applicant has submitted their online application and paid the non-refundable application fee of $120, Carleton will email instructions on how to access Carleton Central and the applicant will be assigned a User ID.
- A complete list of admission requirements can be found here.
- The following documents are required for the application:
- Transcripts (all post-secondary transcripts are required)
- Two (2) letters of reference (should be submitted by former professors, preferably project/thesis supervisors). If the applicant has had some experience in clinical trials and regulatory affairs previously, at least one letter of reference from a supervisor is preferred.
- Statement of Intent
- CV/Resumé
- Language Proficiency (ESL Test Scores are required, if applicable) – full details here
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The MSc in Clinical Trials and Regulatory Affairs is a 16-month program for which we only admit students once per year, in the Fall term. The preliminary deadline is February 1st, from which we will fill most of our available spaces. The online application system will remain open until August 1st, however remaining spaces will be very limited.
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The tuition fees for the MSc in Clinical Trials and Regulatory Affairs are yet to be finalized. They are expected to align closely with those of the Master of Biotechnology. For a general estimate, students can expect a tuition of approximately $12,500 per term plus the miscellaneous fees (i.e., Campus Services, Health Insurance, UPASS, and UHIP). Please review the Master of Biotechnology tuition information for more details on fee structure and updates.
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Yes – The program currently includes three in-person sessions of approximately five days each. A study permit is required for students who wish to attend these sessions in Canada. A short-term study permit is not applicable since the program duration exceeds six months.
We understand that some international students may experience delays or difficulties obtaining a study permit. We are committed to being flexible and will work with students facing challenges to explore alternative arrangements where possible. However, students should know they cannot attend in-person components in Canada until their study permit is approved. Additionally, Carleton University does not issue refunds if a study permit application is denied.
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According to Immigration, Refugees and Citizenship Canada (IRCC) guidelines, students must complete at least 51% of their studies in-person to qualify for a Post-Graduation Work Permit. Since the MSc in Clinical Trials and Regulatory Affairs program is primarily online, with only three short in-person components (of approximately five days each), it does not meet the eligibility requirements for the PGWP.
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A Provincial Attestation Letter (PAL) is a document the Government of Canada requires for study permit applications. Carleton University will issue PALs through the Graduate Admissions Office once an admitted student has confirmed their acceptance and paid the required deposit. However, PAL allocations are limited, and Carleton is awaiting further details from the province regarding their distribution. Students should ensure they meet all other visa requirements and be prepared for potential processing delays due to current IRCC staffing reductions.