Standard Operating Procedures for Clinical Research

Kingston General Hospital (KGH) belongs to the Network of Networks (N2); a national initiative that brings together disease networks, academic healthcare organizations and universities committed to research excellence and enhancing Canada's clinical research capability and capacity.  N2's templates, tools, standard operating procedures (SOP's), and educational materials are available free of charge to research teams at KGH.  To obtain access to the material, please contact Veronica Harris-McAllister at (613) 549-6666 X3653 or harrismv@kgh.kari.net.

Reminder: The N2 SOP's are an extension of KGH Policy Number 11-152.  Its contents are applicable hospital-wide and all clinical researchers conducting research within KGH will adopt and adhere to the procedures outlined below:

Procedure Index

• Standard Operating Procedure 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: Submissions and Ongoing Communication
• Informed Consent Process
• Subject Recruitment and Screening
• Management of Investigational Drug Products and Medical Devices
• Management of Biological Specimens
• Adverse Event and Serious Adverse Event Reporting
• Study Monitoring and Communication
• Clinical Data Management
• Investigator Study Files and Essential Documents
• Study Close-Out
• Audits and Inspections
• Clinical Trial Applications
• Confidentiality and Privacy
• Case Report Form Design
• Study Analysis and Reporting
• Protocol Development
• Acronyms and Glossary of Terms