Standard Operating Procedure for Managing Finances and Budgeting in Clinical Research

Purpose

This SOP outlines the procedures for financial management and budgeting in clinical trials and clinical studies. The goal is to ensure efficient and transparent use of funds while maintaining compliance with financial regulations and study protocols.

Scope

This SOP applies to all personnel involved in clinical trials and clinical studies, including principal investigators, study coordinators, finance and grants management staff, and other relevant personnel.

Responsibilities

• Principal Investigator (PI): Oversees financial management of the study, including budget planning and approval of expenditures.
• Finance and Grants Management Staff: Prepare, monitor, and report on budgets; handle billing and payments; ensure compliance with financial regulations.
• Study Coordinators: Assist in budget planning and monitor expenses during the study.

Procedure

• Budget Planning:
  • Develop a detailed study budget, including anticipated expenses such as personnel, supplies, equipment, and participant payments.
  • Incorporate funding sources and constraints into the budget planning process.
  • Submit the budget for approval by institutional and grant oversight bodies as needed.
• Financial Monitoring and Reporting:
  • Track expenses regularly to ensure adherence to the approved budget and identify potential deviations.
  • Prepare periodic financial reports for internal and external stakeholders, including funding agencies.
  • Adjust the budget as necessary with appropriate approvals and document any changes.
• Billing and Payments:
  • Manage billing and invoicing processes, ensuring timely and accurate payments for services and goods.
  • Maintain records of payments and receipts for auditing and compliance purposes.
• Financial Compliance:
  • Ensure compliance with institutional, federal, and other applicable financial regulations and policies.
  • Coordinate audits and respond to any financial review requests as needed.
• Training and Education:
  • Provide training to study personnel on financial management policies and procedures, including budget adherence and reporting requirements.
  • Offer ongoing education and support on financial best practices and compliance issues.

Abbreviations Used

• SOP: Standard Operating Procedure
• PI: Principal Investigator

Documents

• Study budgets and financial reports
• Billing and invoicing records
• Receipts and payment records
• Audit reports and compliance documentation
• Training materials

References

• Institutional financial policies and procedures
• Regulatory guidelines (e.g., FDA, EMA, ICH-GCP)
• Grant and funding agency requirements

SOP Version

Version: 1.0