Standard Operating Procedure (SOP) for Monitoring Preclinical Study Progress

1) Purpose

The purpose of this Standard Operating Procedure (SOP) is to define the procedures for monitoring the progress of preclinical studies. Monitoring the progress of preclinical studies is critical to ensure that they are conducted according to the study protocol, on schedule, and within budget. This SOP outlines the process for tracking the progress of preclinical studies, identifying potential issues early, and taking corrective actions to ensure the study meets its objectives and regulatory requirements.

2) Scope

This SOP applies to all personnel involved in monitoring the progress of preclinical studies. It covers the tracking of timelines, study milestones, resource allocation, data collection, and compliance with study protocols. This SOP is relevant to study directors, project managers, regulatory affairs personnel, quality assurance (QA) staff, and other stakeholders involved in the oversight of preclinical study activities.

3) Responsibilities

• Study Directors: Oversee the overall progress of the preclinical study, ensuring adherence to the study protocol, timelines, and regulatory requirements. Take corrective actions when necessary to address deviations.
• Project Managers: Coordinate study activities, track milestones, monitor resource allocation, and ensure that the study progresses as planned. Provide regular progress updates to senior management.
• Regulatory Affairs Personnel: Ensure that the study is in compliance with regulatory guidelines and that all documentation is complete and accurate for submission to regulatory authorities.
• Quality Assurance (QA): Conduct periodic audits and reviews to ensure that the study is being conducted according to GLP standards and that data quality is maintained.
• Laboratory Technicians: Carry out the study protocol as designed, recording data, and reporting any issues or deviations from the study protocol promptly.

4) Procedure

The following steps outline the procedure for monitoring preclinical study progress:

1. Step 1: Initial Study Setup
   1. Ensure that the study protocol is finalized, approved, and signed off by all relevant stakeholders before the study begins.
   2. Confirm that all necessary resources (e.g., study materials, equipment, personnel) are available and in place to execute the study according to the protocol.
   3. Establish study milestones, timelines, and deliverables. Define the key study stages and identify the critical paths for success.
2. Step 2: Study Kickoff and Coordination
   1. Hold a study kickoff meeting with the study team to review the protocol, timeline, and responsibilities.
   2. Ensure that all team members are aware of their roles and expectations for the study, and that any concerns are addressed before the study begins.
   3. Assign a project manager or study coordinator to be responsible for day-to-day management of the study progress.
3. Step 3: Progress Tracking and Monitoring
   1. Monitor study progress against the established milestones and timelines. Track key events, such as dosing schedules, data collection points, and analysis phases.
   2. Utilize project management tools, spreadsheets, or databases to document and visualize the study progress, highlighting any delays or deviations from the plan.
   3. Hold regular meetings with the study team to discuss progress, identify challenges, and ensure that the study remains on track.
4. Step 4: Data Collection and Review
   1. Ensure that data collection is ongoing as per the study protocol. Verify that the data is being recorded accurately and consistently.
   2. Review interim results and provide feedback to the study team. Address any discrepancies or issues that may affect the study outcomes.
   3. Ensure that all raw data, reports, and documentation are kept up to date and easily accessible for further analysis and reporting.
5. Step 5: Issue Resolution and Corrective Actions
   1. Identify any issues or deviations from the study protocol early and take corrective actions. This may include adjusting timelines, resources, or experimental protocols.
   2. Document any deviations and justify why they occurred. Implement corrective and preventive actions (CAPAs) to prevent similar issues in future studies.
   3. Ensure that the study team is informed of any changes to the study protocol or timeline, and that these changes are appropriately documented.
6. Step 6: Final Review and Reporting
   1. At the completion of the study, conduct a final review of the study data, ensuring that all objectives were met and that the data is complete and accurate.
   2. Prepare a final study report that summarizes the progress, findings, and any issues encountered during the study. This should include recommendations for future studies or clinical trials based on the findings.
   3. Ensure that the final report is submitted to all relevant stakeholders, including senior management, regulatory authorities, and the research and development team.
7. Step 7: Archiving of Study Data
   1. Ensure that all study data, including raw data, final reports, and supporting documentation, are archived according to internal data retention policies.
   2. Ensure that archived materials are stored securely and are accessible for future reference, audits, or regulatory reviews.
8. Step 8: Sample Disposal
   1. Dispose of all biological samples, chemicals, and laboratory waste generated during the study in accordance with biosafety and waste disposal regulations.
   2. Ensure that hazardous materials are disposed of in designated biohazard or chemical waste containers to minimize environmental impact.

5) Documents

The following documents should be maintained during the monitoring of preclinical study progress:

1. Study Protocols
2. Study Progress Logs
3. Interim Reports
4. Deviation and Corrective Action Records
5. Final Study Reports
6. Data Collection and Verification Logs
7. Audit and Review Records
8. Waste Disposal Records

6) Abbreviations

• GLP: Good Laboratory Practices
• FDA: Food and Drug Administration
• QA: Quality Assurance
• CAPA: Corrective and Preventive Action
• IND: Investigational New Drug

7) References

References to regulatory guidelines and scientific literature that support this SOP:

• OECD Guidelines for Good Laboratory Practice (GLP)
• FDA Guidelines for Preclinical Safety Testing
• ICH E6 Good Clinical Practice Guidelines
• International Standards for Monitoring Preclinical Studies

8) Version

Version 1.0: Initial version of the SOP.

9) Annexure

Study Progress Tracking Template