Health Canada Clinical Trial Period

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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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Health Canada: Period Reduced for Keeping Clinical Trial Records

(5 days ago) WEB2 March 2022. “Health Canada is reducing the retention period for clinical trial records for drugs and natural health products from 25 years to 15 years under the Food and Drug …

https://healthresearchbc.ca/news_article/health-canada-period-reduced-for-keeping-clinical-trial-records/

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Canada Finally Reduces Its Clinical Trial Records Retention …

(6 days ago) WEBAs of February 11, 2022, the retention period for records of clinical trials of drugs and natural health products has been reduced from 25 years to 15 years in …

https://www.mondaq.com/canada/life-sciences-biotechnology--nanotechnology/1171468/canada-finally-reduces-its-clinical-trial-records-retention-period-to-align-with-international-standards

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Health Canada Changes Time for Keeping Clinical trial Records for …

(Just Now) WEBHealth Canada is pleased to announce they have reduced the period for keeping clinical trial records for drugs and natural health products from 25 years to 15 …

https://n2canada.ca/health-canada-changes-time-for-keeping-clinical-trial-records-for-drugs-and-natural-health-products/

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

(5 days ago) WEB39 (1) A person that is authorized under Part 4 of the Natural Health Products Regulations to sell or import a natural health product for the purposes of a clinical trial …

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

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Reduction to clinical trial records retention period 101

(1 days ago) WEBHealth Canada has recently announced a reduction of the retention period for clinical trial records for drugs, biologics and natural health products from 25 years …

https://www.advancinghealth.ubc.ca/research-in-action/reduction-to-clinical-trial-records-retention-period-101/

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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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What are clinical trials? - CIHR - Canadian Institutes of Health …

(6 days ago) WEBWhat are clinical trials? A clinical trial is a research study involving human participants that evaluates the safety and/or effects of one or more interventions on health …

https://cihr-irsc.gc.ca/e/52988.html

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Clinical Research Regulation For Canada ClinRegs

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

https://clinregs.niaid.nih.gov/country/canada

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Current state of Health Canada regulation for cellular and gene …

(7 days ago) WEBA CTA filing is submitted for review by Health Canada before the initiation of each of phases 1–3 clinical trials [14], with a 30-day default review period, which, if …

https://www.sciencedirect.com/science/article/pii/S1465324919300416

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TCPS 2 (2018) – Chapter 11: Clinical Trials - ethics.gc.ca

(7 days ago) WEBThese conditions are drawn from the recommendations of the Final Report of the National Placebo Working Committee on the Appropriate Use of Placebos in Clinical Trials in …

https://ethics.gc.ca/eng/tcps2-eptc2_2018_chapter11-chapitre11.html

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Canada finally reduces its clinical trial records retention period to

(3 days ago) WEBAs of February 11, 2022, the retention period for records of clinical trials of drugs and natural health products has been reduced from 25 years to 15 years in Canada.

https://www.lexology.com/library/detail.aspx?g=13b11198-1d12-4800-8a7d-957022e04422

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Early Impact of Health Canada’s New Guidelines - Privacy Analytics

(5 days ago) WEBHealth Canada has introduced new regulatory guidance for anonymizing clinical study reports. As background, Bill C-17 Protecting Canadians from Unsafe …

https://privacy-analytics.com/resources/articles/early-impact-of-health-canadas-new-guidelines/

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Clinical Trial Approval Process In Canada Credevo Articles

(6 days ago) WEBThe CTA is composed of three Modules: Module 1 – Contains administrative and clinical information about the proposed trial. Module 2 – Contains Quality …

https://credevo.com/articles/2017/08/28/clinical-trials-approvals-in-canada/

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Frontiers Quality and quantity of data used by Health Canada in

(7 days ago) WEBThe Summary Basis of Decision documents of Health Canada were used to identify patient demographics in clinical trials and clinical trial characteristics. Results: Health …

https://www.frontiersin.org/articles/10.3389/fmed.2023.1299239/full

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HCA Healthcare - Clinical Trial by Harvard Pilgrim Health Care

(6 days ago) WEBAn automated outbreak detection tool reduced the size of outbreaks by 64% in the trial period preceding the COVID-19 pandemic in a study of 82 hospitals An …

https://investor.hcahealthcare.com/news/news-details/2024/Clinical-Trial-by-Harvard-Pilgrim-Health-Care-Institute-HCA-Healthcare-UCI-Health-and-CDC-Identifies-Strategy-to-Rapidly-Detect-and-Respond-to-Hospital-Outbreaks-Using-Algorithm-Driven-Technology/default.aspx

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