Health Canada Clinical Trials Guidance

Listing Websites about Health Canada Clinical Trials Guidance

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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Registration of Clinical Trials and Public Disclosure of

(4 days ago) WEBImage Text View or download; FIGURE 2 – Search results page, table view. This image represents the Search results page for the new Canadian clinical trial portal. At the top is a header with a dark …

https://www.canada.ca/en/health-canada/programs/consultation-registration-clinical-trials-public-disclosure-results-new-guidance-public-search-portal.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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Health Canada Regulations and Guidances Faculty of Medicine

(6 days ago) WEBGuidance for Clinical Trial Sponsors: Clinical Trial Application; Food and Drug Regulations, Division 5; Medical Device Regulations, Part 3; Natural Health Products, …

https://www.ualberta.ca/medicine/resources/clinical-trials-office/regulations-guidelines-declarations/health-canada-regulations-and-guidances.html

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Clinical trial registration and results reporting: a call for

(9 days ago) WEBIn the interim, Health Canada has endeavoured to modernize its oversight of clinical trials.9 In February 2023, it published draft guidance on trial registration and …

https://www.cmaj.ca/content/196/18/E628

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New CIHR requirements for registration and public disclosure of …

(6 days ago) WEBPublications describing clinical trial results must be open access from the date of publication. Summary results must be publicly available within 12 months from the last …

https://cihr-irsc.gc.ca/e/52810.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

(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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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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Clinical Research Regulation For Canada and United States ClinRegs

(9 days ago) WEBHealth Canada. As per the CanadaFDA, the CanadaFDR, the G-CanadaCTApps, and CAN-29, Health Canada (HC) is the competent authority responsible for clinical trial …

https://clinregs.niaid.nih.gov/country/canada/united-states

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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 TRIALS HANDBOOK - Baker McKenzie

(5 days ago) WEBIntroduction. In Canada, a clinical trial for a drug product (CT) comprises an investigation for use in humans that is intended to discover or verify the clinical, pharmacological or …

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

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Standard Operating Procedure Clinical Trial Applications (Drugs)

(6 days ago) WEBHealth Canada Guidance for Clinical Trial Sponsors: Clinical Trial Applications (last revised 2016) 4.2. Health Canada Guidance Document: Part C, Division 5 of the Food …

https://www.vchri.ca/sites/default/files/sop018_03_clinicaltrialapplicationsdrugs_20210514_0.pdf

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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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Health Canada – Final version of GUI-0100 now available

(6 days ago) WEBThe content of Guidance for Records Related to Clinical Trials (GUI-0068, May 2006) published by Health Canada, which is replaced by GUI-0100. Frequently asked …

https://www.ctg.queensu.ca/bulletin/health-canada-%E2%80%93-final-version-gui-0100-now-available

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Drug Development Timelines: How Health Canada’s 30-Day …

(1 days ago) WEBAccording to the new EU-CTR regulations, clinical trial review timelines may vary from 60 to 106 days for Part I Assessment (with a comparable timeline for Part II Assessment), …

https://canada.altasciences.com/resource-center/blog/drug-development-timelines-how-health-canadas-30-day-regulatory-review-process

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Clinical Trial Design: From Initial Concept to Regulatory Approval

(Just Now) WEBMED284. Stanford School of Medicine. This course teaches the basic elements of clinical trial design, implementation and analysis including small phases of clinical trials. …

https://online.stanford.edu/courses/med284-clinical-trial-design-initial-concept-regulatory-approval

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New guidelines for depression care emphasize patient

(2 days ago) WEBUniversity of British Columbia. "New guidelines for depression care emphasize patient-centred approach." ScienceDaily. ScienceDaily, 8 May 2024. …

https://www.sciencedaily.com/releases/2024/05/240508113132.htm

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