Clinical trials manual health canada

Cancer Management Manual. As part of its responsibility to establish a coordinated, province-wide program of cancer control for residents of British Columbia, BC Cancer has prepared this cancer management manual. This manual is based on the accumulated experiences of BC Cancer together with best-practice evidence derived from major cancer. In addition to performing routine clinical PET/CT scans, the Functional Imaging program in Vancouver also conducts clinical trials investigating new PET radiotracers. Page Content These trials are approved by the UBC BC Cancer Research Ethics Board and Health Canada. Health Canada is the federal regulator responsible for authorizing the importation and sale of drugs for the purpose of clinical trials. This responsibility is fulfilled through the review of clinical trial applications (CTAs) for phase I, II, and III clinical trials, filed by clinical trial sponsors.

Merck cares deeply about helping the world be well. We strive to improve health for others in the future by developing new drugs and vaccines that treat and prevent disease. Clinical trials are an essential part of this process. We are thankful for the thousands of volunteers — patients and healthy persons — who participate in clinical trials. With Health Canada inspecting just a sliver of the country's clinical trials, much of the responsibility for oversight falls to the drug companies sponsoring the trials, as well as the research. Health Canada • Standards for clinical trials in type 2 diabetes in Canada • Clinical Trial Applications • Clinical Trial Applications for comparative bioavailability studies for pharmaceuticals • Quality (chemistry and manufacturing) guidance for pharmaceuticals, biologics, and radiopharmaceuticals • Inclusion of women in clinical trials.

Health Canada • Standards for clinical trials in type 2 diabetes in Canada • Clinical Trial Applications • Clinical Trial Applications for comparative bioavailability studies for pharmaceuticals • Quality (chemistry and manufacturing) guidance for pharmaceuticals, biologics, and radiopharmaceuticals • Inclusion of women in clinical trials. Health Canada also gives Canadians information about clinical trials so that they can make choices based on what they have learned. The clinical trials database lists all of the phase 1, 2 and 3 clinical trials involving patients in Canada. It has information on the: sponsor and title of the study. drug being tested. Standards for Clinical Trials in Type 2 Diabetes in Canada [] Clinical Trials Manual; ICH Guidances; Guidance for Clinical Trial Sponsors: Clinical Trial Applications [] The Common Technical Document - ICH Topic M4 [] Inclusion of Women in Clinical Trials [].