Quality Assurance

BCCHR 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, BCCHR 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.

How to Access N2 Online Resources

BCCHR members and research staff can request a login and password by contacting Jennifer Myers, Research Education Manager, at 604-875-3722 or jmyers@cfri.ca.

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.