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ASK JEAN Fall 2020: Clinical Trial Application Default Period Order

…pharmaceuticals, biologics and medical device trials. https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/clinical-trials/covid-19-order-extension.html Do you have questions or further inquiries for Health Canada? Pharmaceutical drug trials: hc.oct.enquiries-requetes.bec.sc@canada.ca Biologic drugs trials (including blood and blood components): hc.brdd.ora.sc@canada.ca…

ASK JEAN: Single-patient Studies & CONSERVE Guidelines

…an example. The CONSERVE guideline has been made available on the SPIRIT and CONSORT website and on the Enhancing the Quality and Transparency of Health Research (EQUATOR) network (https://www.equator-network.org/). If…

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…