Standard Operating Procedure for Sponsor and CRO Communication

Purpose

This SOP outlines the procedures for communication with sponsors and Contract Research Organizations (CROs) in clinical trials and clinical studies. The goal is to establish clear, efficient, and effective communication channels to support study execution, monitoring, and reporting.

Scope

This SOP applies to all personnel involved in communicating with sponsors and CROs in clinical trials and clinical studies, including principal investigators, clinical research coordinators, and other study staff.

Responsibilities

• Principal Investigator (PI): Leads communication with sponsors and CROs, ensuring study execution aligns with the sponsor’s and CRO’s expectations.
• Clinical Research Coordinators: Assist in coordinating communication with sponsors and CROs and maintaining documentation.
• Study Staff: Support communication efforts and provide updates to sponsors and CROs as necessary.

Procedure

• Establishing Communication Channels:
  • Identify appropriate points of contact at the sponsor and CRO.
  • Set up regular communication schedules, including meetings, calls, and emails, to provide updates and discuss study progress.
• Sharing Study Progress:
  • Provide updates on study progress, including enrollment, data collection, and safety monitoring, as agreed upon with the sponsor and CRO.
  • Share any issues or concerns that may impact the study’s success or compliance with regulatory requirements.
• Collaboration and Problem-Solving:
  • Work collaboratively with the sponsor and CRO to resolve any issues that arise during the study.
  • Provide timely and accurate information to assist in decision-making and problem-solving.
• Documentation and Record-Keeping:
  • Maintain records of communication with the sponsor and CRO, including meeting minutes, emails, and phone call summaries.
  • Keep track of any agreements, decisions, or action items discussed during communication.
• Continuous Improvement:
  • Gather feedback from the sponsor and CRO on the communication process and make improvements as necessary.
  • Adapt communication strategies to align with the sponsor’s and CRO’s expectations and study needs.

Abbreviations Used

• SOP: Standard Operating Procedure
• PI: Principal Investigator
• CRO: Contract Research Organization

Documents

• Communication logs and meeting minutes
• Agreements and action items from sponsor and CRO meetings
• Correspondence with sponsors and CROs

References

• Regulatory guidelines for communication with sponsors and CROs
• Institutional policies for communication management

SOP Version

Version: 1.0