Standard Operating Procedure for Community Relations and Engagement

Purpose

This SOP outlines the procedures for engaging with and outreaching to the community in the context of clinical trials and clinical studies. The goal is to build trust, establish effective communication, and promote awareness and understanding of the study within the community.

Scope

This SOP applies to all personnel involved in community engagement and outreach for clinical trials and clinical studies, including principal investigators, clinical research coordinators, and study sponsors.

Responsibilities

• Principal Investigator (PI): Oversees community engagement and outreach efforts and ensures alignment with study goals.
• Clinical Research Coordinators: Support community engagement and outreach activities, including organizing and attending events.
• Study Sponsors: Provide resources and support for community engagement and outreach initiatives.

Procedure

• Community Engagement Plan:
  • Develop a community engagement plan that outlines strategies and objectives for engaging with the community.
  • Identify target audiences and tailor outreach efforts to meet their needs and concerns.
• Communication and Outreach:
  • Communicate the purpose and importance of the study to the community through various channels (e.g., meetings, brochures, social media).
  • Address community questions and concerns about the study and provide accurate and transparent information.
• Partnerships and Collaborations:
  • Establish partnerships and collaborations with community organizations, advocacy groups, and local leaders.
  • Work together with partners to facilitate participant recruitment and retention.
• Education and Awareness:
  • Organize educational events, workshops, and seminars to raise awareness about the study and its potential benefits.
  • Provide accessible information about the study to community members, including potential participants and stakeholders.
• Feedback and Improvement:
  • Gather feedback from the community on engagement and outreach activities and use it to improve future initiatives.
  • Document lessons learned and best practices to guide future community engagement efforts.

Abbreviations Used

• SOP: Standard Operating Procedure
• PI: Principal Investigator

Documents

• Community engagement plan
• Outreach materials (e.g., brochures, presentations)
• Meeting and event reports
• Feedback forms and reports

References

• Institutional policies for community engagement and outreach
• Regulatory guidelines and ethical considerations for community outreach

SOP Version

Version: 1.0