Program Requirements – MSc in Clinical Trials and Regulatory Affairs

This is a 0-credit course. Introduction to statistical software used to analyze health research data. Data management topics include data entry, manipulation, and elementary statistical analyses using SAS, SPSS, Stata and R. Other topics include privacy/maintaining security of health datasets. For students without strong backgrounds in biostatistics/data handling.

Includes: Experiential Learning Activity

This is a 0-credit course. Overview of the vast area of clinical trials of drugs and devices, and principles of informed consent, regulatory requirements, rigorous documentation, analysis, and reporting. Students will also work on certificates in biomedical ethics, good clinical practice, and others, for example from CITI Canada.

This is a 0.5 credit course. Fundamentals of trials of health products and different phases and types of clinical trials. Investigator vs. sponsor-initiated trials, different regulatory agencies, the use of randomization, blinding, registration regulatory requirements, rigorous documentation, and common trials.

This is a 0.5 credit course. The importance of efficacy and safety measurements, biosamples, pharmacokinetics, pharmacodynamics, drug mechanism of action, reporting of harm, Data and Safety Monitoring Board, pharmacovigilance, and consideration of special populations. Good clinical practice, good medical practice, and good laboratory practice.

Includes: Experiential Learning Activity

This is a 0.5 credit course. Regulatory agencies (Health Canada, US Food and Drug Administration, European Medicines Agency) will be compared. Harmonization efforts of national drug approval agencies, timelines for an investigational New Drug Application including labeling, accelerated approval, breakthrough designation, orphan drugs, and biologics licence application.

This is a 0.5-credit course. Randomization, biomarkers, endpoints, estimands, sample size requirements, random error and bias, multiple testing correction, intent-to-treat versus per-protocol, equipoise and stopping rules for trials, database development, validation and reporting/transferring, development of statistical analysis plans, and considerations around missing data.

This is a 0.5-credit course. Overview of regulatory requirements of pharmaceutical companies, contract research organizations, and communication with regulatory agencies. Negotiation and collaboration between sectors, incentives such as FDA priority review vouchers, project management, manufacturing and distribution, phase IV post-marketing and continued monitoring, pharmacovigilance, and post-marketing changes.

This is a 0.5-credit course. Clinical protocols, electronic case report forms and guidelines, data management plan, monitoring plan, pharmacy manual, standard operating procedures, manual of operating procedures, delegation of authority logs and training logs. Leadership, logistics, and budgeting.

This is a 0.5-credit course. Other trial designs, recruitment of patients, data collection and quality control, interim monitoring, audits, inspections, and timelines. Includes a four to six-week placement at a clinical or regulatory site, contract research organization (CRO), or similar institution involved in clinical trials.
Includes: Experiential Learning Activity

This is a 0.5-credit course. Patient engagement, equipoise, informed consent, ethics board, monitoring, reporting/release of data in the literature, compassionate/expanded access, patient foundations, liaisons and advocates. Engaging with Indigenous communities and special populations. Considerations around translation research, genetics, biosimilars, and labeling.

This is a 0.5-credit course. This course equips students with the skills to convey complex information in decision-based discussion and explain complex regulatory environments, preparing them for impactful roles in clinical research.
Note: this course may be substituted for another 0.5-credit elective science course (to be determined).

This is a 1.5 capstone credit course required for students in the practicum pathway only. This course involves experiential learning at a clinical site, regulatory site, contract research organization (CRO), or similar institution involved in clinical trials. Students will demonstrate the knowledge and skills gained and will present on their experience, efforts, and lessons learned.
Includes: Experiential Learning Activity