Clinical trials at Vitalité Health Network
A clinical trial is a clinical and therapeutic research study involving human participants to evaluate the efficacy, safety and effects of an intervention on clinical outcomes. It is the final step before the launch of any drug, treatment, technique or new therapeutic strategy. Clinical trials ensure that medical innovations offer significant clinical benefits while being tolerated by patients.
At Vitalité Health Network (the Network), the research professionals and nurses of the Clinical Trials Unit (CTU) are responsible for the management of clinical trials and facilitate the process of activating and conducting clinical trials, including:
- feasibility assessment
- negotiating the agreement and budget
- submission to the Research Ethics Board
- conducting the clinical trial
- maintaining regulatory compliance
- patient recruitment and consent
- clinical examinations and follow-ups required by the clinical trial protocol
- clinical data collection and entry
The CTU also plays a central role in supporting clinicians in certain administrative tasks related to clinical trials, and liaises between the Research Ethics Board, sponsors and regulatory bodies as required.
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