A Research Ethics Board for the Independent Review of Clinical Research Conducted in Private Practice Setting.
Bridging the Gap: In Canada, REBs are usually associated with hospitals or universities where academic research is the focus of their review. Guidance for federally funded research is founded in the TriCouncil Policy Statement (TCPS). However, the Health Canada regulations, differs from the TCPS.
Competence: Canadian SHIELD provides a guarantee to Health Canada, to the USA government and the European Union (EU) that it functions in a manner consistent with the provisions of Canadian Food & Drug Regulations, Division 5 (1024 Clinical Trials), HHS Regulations for Protection of Human Subjects (21 CFR 50 & 56 and 45 CFR 46) and ICH (GCP E.6 section 3).
Expedited Processes: Canadian SHIELD Ethics Review Board (CSERB) was formed to expedite clinical trials conducted in private practices across Canada.
The staff of Canadian SHIELD has extensive experience both within the pharma industry and at the research site while Board members are active researchers in private practice and hospital / university based research.
The administrative burden on both the Sponsor as well as the site staff has been carefully reviewed to ensure the focus remains on the review of the proposed study and not the paperwork.
Independent: Canadian SHIELD Ethics Review Board is an independent body not associated with any research site, SMO, CRO or study sponsor.