PCL102H1 Lecture Notes - Lecture 21: Good Clinical Practice, Informed Consent, Research
17 Mar 2016
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Lecture 21 clinical research and clinical trials. Types of clinical studies o: 2nd type: clinical trials. Graph showing clinical trial participation in ontario. Results show that people are being treated for a disease don"t necessarily go forward and enroll in clinical trials low recruitment means they have to do a lot more trials to achieve results. Health canada regulated clinical trials in canada. International guidelines of harmonization canada adopted this. Requires companies to have a health canada documents and have detailed list of responsibilities of investigator, sponsors and research ethics board. Research ethics board (reb) can be institutional or independent, responsibility is to safeguard the. Before clinical trial starts, the principle investigator must submit an application to the reb fro approval to make sure gcp guidelines are being followed. To gain permission for ct. reb application should have the following components: recruitment, consent, balance risk vs. befit in research , confidentiality , fairness and equity and conflicts of interest.
