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ASK JEAN: Clinical Trial Records

…Trials for Medical Device and Drugs Relating to COVID-19. Health Canada will be updating the policies, guidance documents and other documents which currently do not align with this change. https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-clinical-practices.html…

ASK JEAN: What is a UTN?

…and will provide consistent metrics. The UTN is not yet mandatory, but many registries are now moving towards that. Detailed information on the new UTN can be found at https://www.who.int/ictrp/unambiguous_identification/utn_faq/en/#field…

Regulatory update: Critical to Quality Factors

…end of the E8R1 document.   References and Links The new ICH guidelines database and directory is located at https://www.ich.org/page/search-index-ich-guidelines International Council for Harmonisation of Technical Requirements for Pharmaceuticals for…

Regulatory update: Spring 2022

…and conditions Decentralized trials Service provider oversight Transparency https://www.canada.ca/en/health-canada/programs/consultation-clinical-trials-regulatory-modernization-initiative/what-we-heard.html   Health Canada – Drugs and Natural Health Product Records Retention Change See the ASK JEAN article for an update on…

Survivors shape research on brain injury after intimate partner violence

…Oct;23(4):1270-1287. doi: 10.1177/1524838019850623. Retrieved June 13, 2023 from https://pubmed.ncbi.nlm.nih.gov/31170896/ Healthlink BC. (2023). Traumatic brain injury. Retrieved May 18, 2023 from https://www.healthlinkbc.ca/health-topics/traumatic-brain-injury Nanaimo Brain Injury Society. (2022). Workshop evidence synthesis and…