12. Resources (listed in descending order of precedence)

1. Health Canada main page

https://www.canada.ca/en/health-canada.html  

2. Food and Drugs Act_RSC,1985 (last amended 22 Dec 2023)

https://laws-lois.justice.gc.ca/eng/acts/f-27/ 

3. Food and Drug Regulation CRC, c870 (last amended 24 Nov 2023)

https://laws-lois.justice.gc.ca/eng/regulations/c.r.c.,_c._870/index.html 

4. Health Canada- Public Health Agency of Canada (PHAC)- Research Ethics Board

https://www.canada.ca/en/health-canada/services/science-research/science-advice-decision-making/research-ethics-board/about-us.html  

5. Health Canada- PHAC-REB (Consent process)

https://www.canada.ca/en/health-canada/services/science-research/science-advice-decision-making/research-ethics-board/consent-process.html   

6. HC- Biologics, radiopharmaceuticals and genetic therapies

https://www.canada.ca/en/health-canada/services/drugs-health-products/biologics-radiopharmaceuticals-genetic-therapies.html  

7. Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS 2)

https://ethics.gc.ca/eng/policy-politique_tcps2-eptc2_2018.html 

8. HC- Guidance Documents for Clinical Trial Sponsor: Clinical Trial Applications

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

9. Importing and Exporting Health Products for Commercial Use (GUI-0117)

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/importation-exportation/commercial-use-health-products-guidance/document.html  

10. Public Health Agency of Canada (“PHAC”)

https://www.canada.ca/en/public-health.html  

11. Canadian Food Inspection Agency (“CFIA”)

https://inspection.canada.ca/eng/1297964599443/1297965645317  

12. PHAC- Centre for Biosecurity

https://www.canada.ca/en/public-health/services/laboratory-biosafety-biosecurity/about-centre-biosecurity.html  

13. The Human Pathogens and Toxins Act, SC 2009, c 24

https://laws-lois.justice.gc.ca/eng/acts/H-5.67/FullText.html   

14. Human Pathogens and Toxins Regulations (SOR/2015-44)

https://laws-lois.justice.gc.ca/eng/regulations/SOR-2015-44/FullText.html  

15. Canadian Biosafety Standard (CBS)

https://www.canada.ca/en/public-health/services/canadian-biosafety-standards-guidelines/third-edition.html 

16. Canada- Good Clinical Practice: Integrated Addendum E6 R2

https://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/prodpharma/applic-demande/guide-ld/ich/efficac/e6r2-step4-eng.pdf  

17. Qualified Investigator Undertaking

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/forms/qualified-investigator-undertaking.html   

18. HC- Safety Reporting Requirements

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-clinical-practices/guidance-documents/guidance-drugs-clinical-trials-human-subjects-gui-0100/document.html#a514 

19. HC- Regulatory Enrolment Process (REP) for Human and Veterinary Drugs and Disinfectants

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/regulatory-enrolment-process.html   

20. Canadian Trade Controls Bureau (issuing export permits for Biological Products)

https://laws-lois.justice.gc.ca/eng/regulations/sor-89-202/FullText.html  

21. HC- Management of clinical trials during COVID-19 Pandemic: Notice to Sponsors

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/announcements/management-clinical-trials-during-covid-19-pandemic.html#a7  

22. HC- Regulatory Enrolment Process (REP) for Human and Veterinary Drugs and Disinfectants

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/regulatory-enrolment-process.html 

23. HC- Health Canada Clinical Trials Database

https://health-products.canada.ca/ctdb-bdec/brands?medicalConditionName=&protocolTitle=remote&drugName=&sponsorName=&studyPopulationId=&statusId=&nolDateFrom=&nolDateTo=&startDateFrom=&startDateTo=&endDateFrom=&endDateTo=&protocolNo=&submissionNo=&submit=Search 

24. Cross-Canada virtual care licensure requirements and best practices

https://www.blg.com/en/insights/2021/06/cross-canada-virtual-care-licensure-requirements-and-best-practices  

25. Clinical Trials Ontario- Decentralized Trials Resource Guide

https://ctontario.ca/resources/decentralized-trials/remote-data-monitoring/   

26. Canadian Institutes of Health Research: CIHR Best Practices for Protecting Privacy in Health Research 

https://cihr-irsc.gc.ca/e/29072.html  

27. The Officer of the Privacy Commissioner in Canada (FAQs)

https://www.priv.gc.ca/en/privacy-topics/technology/online-privacy-tracking-cookies/online-privacy/cloud-computing/02_05_d_51_cc_faq/ 

28. The Officer of the Privacy Commissioner in Canada: Guidelines for processing personal data across borders

https://www.priv.gc.ca/en/privacy-topics/airports-and-borders/gl_dab_090127/  

29. The Officer of the Privacy Commissioner in Canada: Bill C-11s Treatment of Cross-border Transfer of Personal Information

https://www.priv.gc.ca/en/opc-actions-and-decisions/research/explore-privacy-research/2021/tbdf_scassa_2105/#toc1 

30. FDA- Digital Health Technologies for Remote Data Acquisition in Clinical Investigations

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/digital-health-technologies-remote-data-acquisition-clinical-investigations