Clinical Research Services
Quality Assurance
CFRI is a member organization of Network of Networks (N2), a national initiative led by research networks and other stakeholders to enhance Canada's research capability and capacity.
Through N2, CFRI researchers and staff can access various online resources developed to improve the quality of clinical research. These include an established national standardized set of high-level CanReg Inc. audited standard operating procedures (SOPs), a set of SOP tools, such as checklists, tracking logs and research ethics board (REB) templates, as well as the Good Clinical Practices training program and information on contract negotiations.
Dr. Jean-Paul Collet, Scientist with CFRI’s Innovations in Acute Care & Technology research cluster, and Ms. Lesley Sturrock, Regulatory Affairs Manager for the Clinical Research Support Unit are members of the N2 Board of Directors.
How to Access N2 Online Resources
CFRI members and research staff can request a login and password by contacting Ms. Lesley Sturrock.
Standard Operating Procedures
Regulatory authorities require that clinical researchers use standard operating procedures (SOPs) to ensure that their research is conducted in a manner that protects the rights and safety of study subjects and the integrity of research data.
The N2 SOPs have been developed to be a national standardized set of operating procedures that are applicable to any therapeutic area. The goal was to develop one set of well-written SOPs that would cross all therapeutic areas in any given institution or research environment. N2 will ensure the SOPs are externally reviewed by an independent expert every year or sooner as dictated by changes in the regulations of guidance documents.
The following SOPs are available on the N2 website:
- SOP Administrative Management
- Research Team Roles and Responsibilities
- Research Team Training
- Clinical Research Protocol Feasibility and Site Selection
- Study Initiation Activation
- Informed Consent Forms
- Research Ethics Board (REB) Submissions and Ongoing Communication
- Informed Consent Process
- Subject Recruitment and Screening
- Management of Investigational Drug Products and Medical Devices
- Management of Biological Specimens
- Serious Adverse Reaction (SAR) Reporting in Clinical Trials
- Study Monitoring and Communication
- Clinical Data Management
- Investigator Study Files and Essential Documents
- Study Close-Out
- Audits and Inspections
- Clinical Trial Application
- Confidentiality and Privacy
- Acronyms and Glossary of Terms
The following SOPs tools are available on the N2 website:
- N2_Tool_SOP-01-SOPDistRecord
- N2_Tool_SOP-01-SOPReviewRecord
- N2_Tool_SOP-01-TaskDelTrainingDoc
- N2_Tool_SOP-02-03-EmplAssessment Checklist
- N2_Tool_SOP-02-03-Orient-Checklist
- N2_Tool_SOP-02-03-TaskDelegationForm
- N2_Tool_SOP-02-TaskDelResTeam
- N2_Tool_SOP-03-15-Personnel Documentation (2)
- N2_Tool_SOP-03-ProtocolSkillsAssess
- N2_Tool_SOP-03-TrainingDoc
- N2_Tool_SOP-04-CLIN STUDY FEAS CHECK
- N2_Tool_SOP-04-SiteSelectionVisitCheck
- N2_Tool_SOP-05-StudyActivationChecklist
- N2_Tool_SOP-07-REB SUBMISSION LETTER
- N2_Tool_SOP-07-REBSubmissionChecklist (2)
- N2_Tool_SOP-08-ICF VERIFICATION LIST CONF
- N2_Tool_SOP-08-REF CONF VER PROT OR AMEND
- N2_Tool_SOP-09-RecruitmentPlanOutline
- N2_Tool_SOP-10-DrugAccountLog
- N2_Tool_SOP-10-DrugDispensingLog
- N2_Tool_SOP-12-PatientAEAssessmen Form(PAR)
- N2_Tool_SOP-12-SAE-SafetyLetterTrackingLog
- N2_Tool_SOP-13-SiteMonitoringVisitChecklist
- N2_Tool_SOP-13-TelephoneContactRecord
- N2_Tool_SOP-15-ESSENTIALDOCS
- N2_Tool_SOP-16-StudyCloseoutChecklist
Additional Resources
The following additional resources are available on the N2 website:
- Clinical Studies Agreement Best Practices
- Health Canada pre-inspection package
- GCP training module (ppt)
- GCP training module test questions
- N2 SOP training presentation
- REB Submission Letter template
- Reference for a Verification of a Protocol or a Protocol Amendment
- Recruitment plan outline
- List of Essential Documents for the Conduct of a Clinical Study
- Study Closeout Checklist
- Attendance Training Log
The N2 website also has links to Canadian clinical trial registries, N2 contacts and job postings.
Contacts
Ms. Lesley Sturrock, Regulatory Affairs Manager, Clinical Research Support Unit. Tel: 604-875-3691
Last updated:
12/15/2009
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