Continuing Organizational SOP Needs to Maintain Compliance (Session I)

This webinar recording is part one of a two-part series on adaptive operational optimization through transformative SOPs.

Take a deep dive into transforming operational effectiveness by utilizing three key areas in drafting your clinical research standard operating procedures (SOPs) so they are specific, meaningful, and productive for your unique research organization. By focusing on critical flexibilities in the current challenging environment, ongoing integration of heightened emotional intelligence, and core compliance mechanisms, participants will polish their skill set to craft customized SOPs within their organizations.

This program defines and enumerates the stages of the SOP life cycle beyond merely drafting to include training and enforcement as well. Presenters’ use of case study pedagogy will assist you in interactively drafting an SOP together to demonstrate the importance of flexibility, EQ, and compliance in the SOP life cycle.

Upon completion of this continuing education program, participants should be able:

• Exercise emotional quotient-based design thinking to appropriately draft SOPs that include all potential stakeholders
• Understand common blind spots within basic compliance mechanisms and employ programmatic compliance pillars to provide instant infrastructure to your SOP writing efforts
• Draft more adaptive SOPs with enough specificity that they are valuable reference tools and training materials, but also with enough flexibility that those SOPs can withstand the current challenging COVID research climate and better prepare your organization for new ways of conducting clinical trials

Speaker
Edye Edens, JD, MA, CIP, CCRP, Senior Research Compliance Consultant, First Class Solutions

Approved for 1.0 ACRP Contact Hours | Expires February 4, 2024

View Part 2