Program Description

Quality Improvement through Standard Operating Procedures (SOPs)

Goal:  Standard Operating Procedures (SOPs) are an effective tool to assist in the conduct of high quality clinical trials and minimize risk.

The goal of this interactive 2-day workshop is to introduce participants to the fundamental concepts and current issues in the development and implementation of an effective SOP program for clinical research. The implication of international regulations and inspections regarding systems and procedures related to quality processes will also be discussed.

Participants will develop, critique and improve SOPs for clinical research. SOPs will be developed in a collaborative manner throughout the workshop and participants will return to their work environment following this workshop with a series of effective SOPs.

This workshop consists of lectures, discussions, and interactive group exercises.

Objective:  To define and discuss fundamental concepts and current issues in the development and implementation of an effective SOP program for clinical research and to decrease risk for clinical research sites, sponsors and Ethics Boards. To describe the implications of United States and international regulations and inspections regarding SOPs related to quality processes.

Learning Objectives:

• Define and discuss standard operating procedures (SOPs).
• Describe the benefits of an effective SOP program.
• Discuss the Canadian Regulations regarding systems and procedures of quality processes to be developed and implemented at the clinical site.
• Describe strategies for planning, developing and conducting effective and productive meetings.
• Discuss effective writing strategies.
• Describe the recommended format and content of an effective written procedure.
• Describe how to develop procedures related to workflow.
• Identify policies and procedures appropriate to clinical research.
• Develop a procedure related to the development of a standard operating procedure process.
• Demonstrate an ability to present and discuss participants’ work product.
• Describe factors that assist in the approval and implementation of standard operating procedures.
• Develop an effective standard operating procedure process.
• Demonstrate an ability to present and discuss participants’ work product.
• Discuss effective educational and training programs.
• Discuss how to design policies and procedures to fit the specific needs of an institution.
• Discuss examples of successful implementations.
• Describe key issues related to the development of standard operating procedures for clinical research.
• Describe mechanisms to avoid unsuccessful implementations.