FAQ – MSc in Clinical Trials and Regulatory Affairs

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.

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.

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.

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.

No – This is not a requirement. However, this would be considered as an asset to your application.

No – Since this is a course-based program, students will not require nor be assigned a supervisor.

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.

Applications are submitted online: http://graduate.carleton.ca/apply-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

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 March 1^st, from which we will fill most of our available spaces. The online application system will remain open until August 1^st, however remaining spaces will be very limited.