Clinical Research Services
Quality Assurance
What's New
Click here for free online good clinical practice (GCP) training modules.
About 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 TBD.
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:
- N2 SOP Table of Contents
- N2 SOP Glossary of Terms
- N2 SOP01_03.1 Administrative Management
- N2 SOP02_03 Research Team Roles and Responsibilities
- N2 SOP03_03 Research Team Training
- N2 SOP04_03 Clinical Research Protocol Feasibility and Site Selection
- N2 SOP05_03 Study Initiation Activation
- N2 SOP06_03 Informed Consent Forms
- N2 SOP07_03.1 REB Submissions and Ongoing Communication
- N2 SOP08_03 Informed Consent Process
- N2 SOP09_03 Subject Recruitment and Screening
- N2 SOP10_03 Management of Invest Prod
- N2 SOP11_03 Management of Biological Specimens
- N2 SOP12_03.1 SAR Reporting in Clinical Trials
- N2 SOP13_03 Study Monitoring and Communication
- N2 SOP14_03.1 Clinical Data Management
- N2 SOP15_03 Investigator Study Files and Essential Documents
- N2 SOP16_03 Study Close-Out
- N2 SOP17_03 Audits and Inspections
- N2 SOP18_03 Clinical Trial Application
- N2 SOP19_03 Confidentiality and Privacy
- N2 SOP20_01 CRF Design
- N2 SOP21_01 Study Analysis and Reporting
- N2 SOP22_01 Protocol Development
The following SOPs tools are available on the N2 website:
- N2 Tool SOP-01-SOP Distribution Record
- N2 Tool SOP-01-SOP Review Record
- N2 Tool SOP-01-Task Delegation Training Document
- N2 Tool SOP-02-03-Employee Assessment Checklist
- N2 Tool SOP-02-03-Orientation Checklist
- N2 Tool SOP-02-03-Task Delegation Form
- N2 Tool SOP-02- Tasks Delegation or Assignment of Responsibilities Form
- N2 Tool SOP-03-15-Personnel Documentation
- N2 Tool SOP-03-Protocol Skills Assessment
- N2 Tool SOP-03-Training Document
- N2 Tool SOP-04-Clinical Study Feasibility Check
- N2 Tool SOP-04-Site Selection Visit Checklist
- N2 Tool SOP-05-Study Activation Checklist
- N2 Tool SOP-07-REB Submission Letter
- N2 Tool SOP-07-REB Submission Checklist
- N2 Tool SOP-08-ICF Verification List
- N2 Tool SOP-08-Reference for Verification of Protocol or Protocol Amendment
- N2 Tool SOP-09-Recruitment Plan Outline
- N2 Tool SOP-10-Drug Accountability Log
- N2 Tool SOP-10-Drug Dispensing Log
- N2 Tool SOP-12-Patient AE Assessment Form (PAR)
- N2 Tool SOP-12-SAE Safety Letter Tracking Log
- N2 Tool SOP-13-Site Monitoring Visit Checklist
- N2 Tool SOP-13-Telephone Contact Record
- N2 Tool SOP-15-Essential Documents List
- N2 Tool SOP-16-Study Closeout Checklist
- N2 Tool Training log
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
Regulatory Environment Officer, Clinical Research Support Unit. Tel: 604-875-3691
Last updated:
09/21/2011
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