4) Procedure

The following steps outline the procedure for risk management in preclinical studies:

1. Step 1: Risk Identification
   1. Conduct a thorough review of the study protocol, objectives, and design to identify potential risks. This includes risks related to study methodology, resource allocation, regulatory compliance, and safety.
   2. Engage all relevant stakeholders, including study directors, scientists, and regulatory personnel, to identify risks from various perspectives, including scientific, technical, regulatory, and operational risks.
   3. Identify risks associated with external factors such as regulatory changes, environmental factors, or potential issues with external testing labs or vendors.
2. Step 2: Risk Assessment
   1. Assess the likelihood and potential impact of each identified risk. Use risk assessment matrices or other tools to categorize risks based on their severity (high, medium, low) and likelihood of occurrence.
   2. Evaluate the potential consequences of each risk on the study’s timeline, cost, quality of data, and regulatory compliance.
   3. Prioritize risks based on their potential impact, ensuring that the most critical risks are addressed first.
3. Step 3: Risk Mitigation Planning
   1. Develop mitigation strategies for high-priority risks. These strategies should aim to reduce the likelihood of risks occurring or minimize their potential impact.
   2. For each identified risk, outline specific actions to mitigate or eliminate the risk, assign responsibility for implementation, and establish a timeline for executing mitigation strategies.
   3. Ensure that contingency plans are in place in case risk mitigation strategies are not fully effective. This includes identifying alternative approaches or resources if risks materialize.
4. Step 4: Risk Monitoring and Tracking
   1. Monitor the progress of risk mitigation efforts and assess their effectiveness. Track key risk indicators throughout the study and adjust strategies as needed.
   2. Conduct regular risk review meetings with the study team to discuss the status of risk mitigation efforts, identify new risks, and evaluate the effectiveness of implemented strategies.
   3. Maintain a risk log that records all identified risks, their assessment, mitigation strategies, and progress updates. Ensure that the risk log is updated regularly and is accessible to relevant stakeholders.
5. Step 5: Risk Communication
   1. Ensure that all stakeholders are kept informed of identified risks, mitigation strategies, and the status of risk management efforts. Provide regular risk updates to senior management, regulatory affairs teams, and other relevant personnel.
   2. Ensure that any significant changes in risk status (e.g., new risks identified, changes in risk likelihood or impact) are communicated promptly to all relevant parties.
   3. Document all communications related to risk management, including risk identification, mitigation plans, and progress reports, for future reference and regulatory compliance.
6. Step 6: Risk Review and Evaluation
   1. At the conclusion of the preclinical study, conduct a final risk review to assess the effectiveness of the risk management plan. Identify any risks that materialized during the study and evaluate how they were handled.
   2. Document lessons learned from the study’s risk management process and use this information to improve risk management practices for future studies.
   3. Ensure that any unresolved risks or issues are documented and addressed before final study reports are submitted to regulatory authorities or other stakeholders.
7. Step 7: Archiving of Study Data
   1. Ensure that all risk management documentation, including risk logs, mitigation plans, and progress reports, are archived according to internal data retention policies and regulatory requirements.
   2. Store archived materials securely, ensuring they are accessible for future reference, audits, or regulatory reviews.
8. Step 8: Sample Disposal
   1. Ensure that all biological samples, chemicals, and laboratory waste generated during the study are disposed of 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 risk management process in preclinical studies:

1. Risk Management Plans
2. Risk Logs
3. Study Protocols
4. Mitigation Strategy Documents
5. Deviation and Corrective Action Records
6. Final Study Reports
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 Risk Management in Drug Development

8) Version

Version 1.0: Initial version of the SOP.

9) Annexure

Risk Management Plan Template