SCPOR Site Management
SCPOR has developed administrative-support, site-management services to assist researchers conducting human clinical trials.
Study-Site Regulatory Documents
SCPOR prepares, collects, and forwards all the necessary study-site regulatory documents to the Sponsor, including, but not limited to: the FDA1572 Form; Health Canada's Qualified Investigator Undertaking Form; current, signed and dated curriculum vitae for the investigator and study staff; current medical license(s); laboratory normal values; accreditation certificates for laboratories and hospitals; research ethics committee rosters; Financial Disclosure Forms; and appropriate protocol signature page(s).
Ethics Review Committee Applications
SCPOR prepares and submits applications to ethics review committees with the goal of optimizing approval times.
- Prepare the application form(s), including a study summary, if required
- Review and revise the consent form to meet local requirements
- Make submissions to the required ethics review committee, such as the University of Saskatchewan Biomedical Research Ethics Board
- For the duration of the study, submit all documents requiring ethical review/approval (including, but not limited to protocol amendments, administrative letters, investigational drug brochures, and serious adverse event reports) to the appropriate committee. All approvals and ethics review committee correspondence are forwarded to the Principal Investigator and Sponsor by SCPOR.