This 3 day, interactive Standard Operating Procedures (SOP) Writing Course for clinical research is designed for the novice or experienced clinical research professional who is required to oversee, administer, manage, write, implement or evaluate procedures – SOPs - for investigational sites, institutions or Institutional Review Boards (IRBs). Both the US Food and Drug Administration (FDA) and Office of Human Research Protection (OHRP), have documented their expectations for SOPs to be in place and adhered to.

At the conclusion of the course, the attendees will be able to write an SOP, conduct an assessment (gap analysis) of SOPs needed for their organization, administer/manage SOPs, conduct employee training on SOPs, and understand what Sponsor-CROs auditors and Regulatory Agency Inspectors will evaluate when reviewing your SOPs.

Faculty:
Liz Wool, RN, BSN, CCRA, CMT
President
Association of Clinical Research Professionals (ACRP)
Northern California Chapter
President and CEO, QD-Quality and Training Solutions, Inc.™

Duration: 24 hours

Course Objectives

• Define a Standard Operating Procedure (SOP)
• Explain the regulatory and human subject protection rationale for SOPs.
• Conduct an assessment (gap analysis) of the organization for SOPs.
• Identify the components, standards and requirements for SOPs.
• Practice writing an SOP.
• Prepare for an audit of the organization's SOPs.
• Describe Good SOP Management Practices.

Course Outline

Agenda

Day 1

• Introduction
• Background and Rationale for SOPs: Update on GCP Trends with the FDA, OHRP, and European Union
• SOPs for Clinical Sites: A Review of US and EU Regulatory Agency Regulations, Guidance Documents and Inspection Findings
• SOPs Part in 'Quality Human Subject Protection'
• SOP Format and Content Standards
• Administration of SOPs: Document Control and Management

Day 2

• Beyond the SOP Concept: Quality Management and Quality Systems
• Site Assessment for SOPs: How to Conduct a GAP Analysis
• Getting Started: The Process Flow Diagram Made Easy
• SOP Writing: Industry Standards and Tips
• How to Prepare for Sponsor-CRO Audits and Regulatory Agency Inspections of your SOPs.

Day 3

• Case Study: Write an SOP!
• Implementing SOPs: Best Practices and Methods
• SOP Training: How to Assign and Evaluate Comprehension and Adherence to SOPs
• SOP Training: Trends, Requirements, Documentation and Best Practices
• Wrap-Up

Registration

• Contact Us to bring this course to your organization.