A clinical trial is an investigation of a drug product or device that involves human participants. Clinical trials study the safety and effectiveness of investigational products/devices for their use in humans, and they undergo regular review by a research ethics board and regulatory authorities. At CAMH, the volume of clinical trials has grown over 47% in the past five years, and continues to grow each year.
The Clinical Trials Unit (CTU) at CAMH supports the design, development, and delivery of clinical research across a wide range of mental health and addictions studies. Our research includes various investigational products including pharmaceutical drugs, controlled/restricted substances, cannabis, natural health products, radiopharmaceuticals and medical devices. We provide centralized expertise and operational support to ensure that trials conducted at CAMH meet the highest standards of scientific, regulatory, and ethical excellence. |
The CTU team works closely with CAMH investigators, research staff, and external partners—including academic collaborators, industry sponsors, and government agencies—to streamline trial start-up processes and facilitate impactful, high-quality research. We provide services in:
- Site selection
- Vendor qualification
- Budget review and negotiation
- Protocol review
- Regulatory applications
- Data and Safety Monitoring Board (DSMB) services
- Clinical trial registration
- REDCap database setup
- Data monitoring
- Biospecimen management
- Audits and regulatory inspection support
- Biostatistics
- Tools and templates