Health Canada Clinical Trials Guidance

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Guidance Document For Clinical Trial Sponsors: Clinical Trial

(5 days ago) May 29, 2013Our file number: 13-108409-403Guidance Document for Clinical Trial Sponsors: … See more

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/clinical-trials/clinical-trial-sponsors-applications.html

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Management of clinical trials during the COVID-19 pandemic

(4 days ago) WEBSponsors may continue to file COVID-related or other clinical trial applications and amendments according to Health Canada guidance. During our …

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/announcements/management-clinical-trials-during-covid-19-pandemic.html

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What We Heard Report: Future of Clinical Trials - CIHR

(6 days ago) WEBThe Canadian Institutes of Health Research (CIHR) is committed to strengthening the clinical trials ecosystem to improve health care and health outcomes for all Canadians. CIHR is now looking to build a long …

https://cihr-irsc.gc.ca/e/53429.html

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Guidance document : Part C, division 5 of the Food and Drug …

(1 days ago) WEBCanada. Health Canada. Title : Guidance document : Part C, division 5 of the Food and Drug Regulations “Drugs for clinical trials involving human subjects”. Electronic …

https://publications.gc.ca/site/eng/9.870384/publication.html

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Management of clinical trials during the COVID-19 pandemic: …

(5 days ago) WEBGuidance documents for management of drugs for clinical trials involving human subjects. The sponsor must ensure that the clinical trial is conducted in accordance with the …

https://open.canada.ca/data/en/dataset/2531e080-bf87-4ef5-a1fd-2ad345bec22b

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Guidance Document For Clinical Trial Sponsors: Clinical Trial

(1 days ago) WEBThe Food and Drugs Act and the Food and Drug Regulations govern the sale and importation of drugs for use in human clinical trials in Canada. This document provides …

https://open.canada.ca/data/en/dataset/73ef69d8-47c1-45d4-ae5b-3e0b10ae44cd/resource/c2e3cacd-fce4-4ecb-9be9-689c519fc51f

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Canada Gazette, Part 2, Volume 156, Number 5: Clinical Trials for

(5 days ago) WEBGuidance on the implementation of the Interim Orders for clinical trials of COVID-19 medical devices is outlined in Health Canada’s Guidance on applications for …

https://www.gazette.gc.ca/rp-pr/p2/2022/2022-03-02/html/sor-dors18-eng.html

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Guidance Document For Clinical Trial Sponsors: Clinical Trial

(5 days ago) WEBThe Food and Drugs Act and the Food and Drug Regulations govern the sale and importation of drugs for use in human clinical trials in Canada. This document …

https://open.canada.ca/data/en/dataset/73ef69d8-47c1-45d4-ae5b-3e0b10ae44cd

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Health Canada Draft Guidance: Disaggregated Data in Clinical …

(Just Now) WEBHealth Canada Draft Guidance Document: On the Collection and Analysis of Disaggregated Data in Clinical Trials. On December 17, 2022, Health Canada pre …

https://dicentra.com/blog/article/health-canada-draft-guidance-document-the-collection-and-analysis-of-disaggregated-data-in-clinical-trials

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Clinical trial inspections - drug-inspections.canada.ca

(6 days ago) WEBClinical trial inspections. Clinical trials in Canada for human drugs must meet high safety standards. Canada inspects clinical trials to reduce the risks to people participating in …

https://www.drug-inspections.canada.ca/gcp/index-en.html

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Guidance Document

(2 days ago) WEBHealth Canada Address Locator 0900C2 Ottawa, ON K1A 0K9 Tel.: 613‐957‐2991 Toll free: 1‐866‐225‐0709 Fax: 613‐941‐5366. TTY: 1‐800‐465‐7735. E‐mail: …

https://publications.gc.ca/collections/collection_2021/sc-hc/H164-271-2019-eng.pdf

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Clinical Trials Research and innovation - University of Ottawa

(6 days ago) WEBFor more information, please refer to Health Canada’s guidance documents. Record keeping : Health Canada requires that all clinical trial records be maintained for a …

https://www.uottawa.ca/research-innovation/ethics/guidelines-policies-procedures/clinical-trials

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Proposed Clinical Trials Strategy for Canada - CIHR

(6 days ago) WEBMessage from the President: Proposed Clinical Trials Strategy for Canada. In the winter of 2023, CIHR published the summary of a public consultation outlining the …

https://cihr-irsc.gc.ca/e/53542.html

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Guidance Document

(2 days ago) WEBMaster Files are voluntary registrations filed with Health Canada that can be referenced by Applicants seeking drug marketing authorizations or clinical trial authorizations …

https://publications.gc.ca/collections/collection_2019/sc-hc/H164-267-2019-eng.pdf

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CLINICAL TRIALS HANDBOOK - Baker McKenzie

(5 days ago) WEBIn Canada, a clinical trial for a drug product (CT) comprises an investigation for use in humans that is intended to ICH Guidance E6: Good Clinical Practice: Consolidated …

https://www.bakermckenzie.com/-/media/files/insight/publications/2019/healthcare/america/dsc125067_clinical-trials-handbook--canada.pdf

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1.2 - Overview of Regulation of Clinical Trials in Canada

(3 days ago) WEBClinical Trial Regulations for Drugs. Regulations prior to September 1st, 2001, were: the IND regulations implemented in the early 60’s. under Division 8 of Part C of the Food …

https://admin.ich.org/sites/default/files/inline-files/Overview_of_Regulation_of_Clinical_Trials_in_Canadapdf.pdf

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Guidance Document: Part C, Division 5 of the Food and Drug …

(1 days ago) WEBHealth Canada is the federal department responsible for helping the people of Canada maintain and improve their health. We assess the safety of drugs and many consumer …

https://publications.gc.ca/collections/collection_2019/sc-hc/H14-313-2019-eng.pdf

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