Standard Operating Procedure for Closing Out Sites and Terminating Clinical Studies

Purpose

This SOP outlines the procedures for conducting site close-out and study termination in clinical trials and clinical studies. The goal is to ensure that sites are closed properly and that all study activities are concluded in compliance with regulatory, ethical, and study-specific requirements.

Scope

This SOP applies to all personnel involved in the close-out of sites and termination of clinical trials and clinical studies, including principal investigators, clinical research coordinators, data management teams, and other study personnel.

Responsibilities

• Principal Investigator (PI): Oversees the close-out of sites and study termination processes, ensuring compliance with study protocols, regulations, and ethical standards.
• Clinical Research Coordinators: Coordinate site close-out activities and ensure that all study documentation is complete and up to date.
• Data Management Team: Finalize data collection, cleaning, and analysis, and prepare data for final storage or transfer.
• Regulatory Affairs Team: Manage regulatory submissions and notifications related to site close-out and study termination.

Procedure

• Site Close-Out Preparation:
  • Review site close-out requirements based on the study protocol and regulatory guidelines.
  • Notify site personnel, participants, and relevant authorities about the upcoming site close-out.
  • Plan and schedule site close-out activities, including final participant visits and data review.
• Final Participant Visits:
  • Conduct final visits with participants to complete assessments, collect data, and discuss the study conclusion.
  • Provide information on post-study care and resources as needed.
  • Collect and reconcile any outstanding data, study-related supplies, and medications.
• Documentation and Data Management:
  • Review and reconcile study records and data for completeness and accuracy.
  • Finalize data cleaning and prepare data for final storage or transfer according to regulatory requirements.
  • Ensure proper archiving and storage of study records and data.
• Regulatory and Ethical Compliance:
  • Submit final reports and documentation to regulatory authorities and ethics committees as required.
  • Notify relevant parties (e.g., funding agencies, sponsors) of study termination and close-out.
  • Ensure compliance with any outstanding regulatory and ethical obligations.
• Site Close-Out Visit:
  • Conduct a site close-out visit to review site operations, records, and compliance with study protocols.
  • Provide feedback to site personnel and document any issues or concerns.
  • Confirm the proper storage or disposal of study materials and supplies.
• Study Termination:
  • Complete any remaining study-related activities, such as data analysis and reporting.
  • Prepare and submit final study reports to relevant parties (e.g., sponsors, ethics committees).
  • Officially terminate the study and communicate termination to all stakeholders.
• Quality Assurance:
  • Conduct quality assurance reviews of site close-out and study termination processes.
  • Identify areas for improvement and document lessons learned for future studies.

Abbreviations Used

• SOP: Standard Operating Procedure
• PI: Principal Investigator

Documents

• Site close-out checklists and plans
• Final participant visit records and data
• Data management and archiving plans
• Final reports and regulatory submissions
• Quality assurance review reports

References

• Institutional policies for site close-out and study termination
• Regulatory guidelines (e.g., FDA, EMA, ICH-GCP)
• Study protocols and investigator brochures

SOP Version

Version: 1.0