Table of Contents: N2 Standard Operating Procedures (SOPs) for regulated clinical research.
The Fraser Health Authority is a member of the Network of Networks (N2) http://n2canada.ca/ , which is a voluntary not-for-profit organization with membership from organizations involved in conducting clinical research from across Canada (e.g. health care delivery organizations, universities, research institutes, contract research organizations and industry).
On behalf of the Fraser Health Authority, which is an institution that permits the conduct of clinical research, the Department of Evaluation and Research Services has adopted these SOPs as the best practice for use by our clinical trial research sites that are conducting drug, device and natural health products research. Standard operating procedures are a regulatory requirement for the conduct of this type of research and are reviewed by Health Canada when site inspections are held.
These SOPs have been developed by the N2 SOP committee and have also been audited by an external auditor for compliance with regulations and ICH/GCP requirements. All SOPs are reviewed bi-annually by the N2 SOP Committee to ensure compliance with regulatory requirements. In addition, sponsors, regulatory inspectors or auditors may be granted access to view the SOPs when required.
These SOPs are available to Fraser Health researchers upon request to the Department of Evaluation and Research Services. Please contact Anat Feldman, Contracts and Business Development Specialist at email@example.com for access.