Standard Operating Procedure for Closing and Reporting Clinical Research Studies
Purpose
This SOP outlines the procedures for closing a clinical trial or clinical study and reporting the results. The goal is to ensure a systematic, organized, and compliant study closure process and accurate reporting of study findings.
Scope
This SOP applies to all personnel involved in study closure and reporting, including principal investigators, clinical research coordinators, data managers, and other study team members.
Responsibilities
- Principal Investigator (PI): Oversees study closure and reporting, ensuring compliance with regulatory requirements and study protocols.
- Clinical Research Coordinators: Assist in closing out the study site and completing all necessary documentation.
- Data Managers: Ensure all data is cleaned, locked, and archived as required.
Procedure
- Preparation for Study Closure:
- Ensure all study activities are complete and participants have completed the final visit.
- Reconcile all study data, ensuring its accuracy and completeness.
- Perform final monitoring visits and address any outstanding issues.
- Documentation and Archiving:
- Complete and submit all required study documents, including case report forms (CRFs), source documentation, and regulatory submissions.
- Archive study records in a secure and organized manner according to regulatory requirements and institutional policies.
- Document study closure in the study master file and maintain the file for future reference.
- Data Cleaning and Locking:
- Review study data for accuracy and consistency.
- Resolve data queries and discrepancies before data lock.
- Lock the study database once all data is clean and ready for analysis.
- Reporting:
- Prepare the final study report, including results and safety findings.
- Submit the final study report to regulatory authorities, the sponsor, and other relevant parties as required.
- Publish or present study findings in scientific journals or conferences, as appropriate.
Abbreviations Used
- SOP: Standard Operating Procedure
- PI: Principal Investigator
- CRF: Case Report Form
Documents
- Study records and source documentation
- Case report forms (CRFs)
- Study master file
- Data cleaning and lock documentation
- Final study report
References
- Regulatory guidelines (e.g., FDA, EMA, ICH-GCP)
- Institutional policies and procedures
SOP Version
Version: 1.0