Standard Operating Procedure (SOP) for Preclinical Study Data Review Meetings

1) Purpose

The purpose of this Standard Operating Procedure (SOP) is to define the process for conducting data review meetings during preclinical studies. These meetings are critical to ensuring that study data is reviewed systematically, any issues are identified promptly, and decisions are made to guide the study towards successful outcomes. This SOP ensures that data review meetings are conducted in a structured, effective, and compliant manner to facilitate data integrity, regulatory compliance, and project success.

2) Scope

This SOP applies to all personnel involved in preclinical study data review meetings. It includes procedures for preparing for data review meetings, conducting the meetings, documenting meeting outcomes, and following up on action items. This SOP is relevant to study directors, project managers, data analysts, quality assurance (QA) staff, regulatory affairs personnel, and other stakeholders who participate in data review meetings for preclinical studies.

3) Responsibilities

• Study Directors: Oversee the data review process, ensure that meetings are conducted according to this SOP, and ensure that all stakeholders participate and contribute appropriately. Approve meeting outcomes and decisions.
• Project Managers: Coordinate the scheduling, preparation, and logistics of data review meetings. Ensure that the meeting agenda is circulated in advance and that action items are tracked and followed up on.
• Data Analysts: Present the data and highlight any trends, inconsistencies, or issues that require attention. Ensure that the data is interpreted correctly and that statistical analyses are reviewed in detail.
• Quality Assurance (QA): Ensure that the data review meetings comply with Good Laboratory Practice (GLP) standards and that documentation of meeting minutes and action items is complete and accurate.
• Regulatory Affairs Personnel: Ensure that data review meetings align with regulatory requirements and that any concerns related to compliance are addressed.

4) Procedure

The following steps outline the procedure for conducting preclinical study data review meetings:

1. Step 1: Scheduling the Meeting
   1. Schedule the data review meeting at regular intervals based on the study timeline, such as after major milestones, data collection points, or the completion of key experiments.
   2. Invite all relevant stakeholders to the meeting, including study directors, data analysts, project managers, regulatory affairs personnel, and QA staff.
   3. Ensure that the meeting is scheduled with sufficient lead time to allow participants to review the data and prepare any necessary materials.
2. Step 2: Preparing for the Meeting
   1. Prepare the meeting agenda, including the key data points or sections of the study to be reviewed (e.g., interim results, data integrity issues, statistical analyses).
   2. Ensure that relevant data is compiled and made available to participants prior to the meeting. This includes raw data, analysis results, and any supporting documentation.
   3. Distribute the meeting agenda and data in advance to allow participants sufficient time to review the information and prepare for the discussion.
3. Step 3: Conducting the Meeting
   1. Start the meeting by reviewing the agenda and setting clear objectives for the meeting. Ensure that all participants are aware of the meeting goals.
   2. Have data analysts present key data, trends, and any issues that have arisen. Focus on addressing discrepancies, anomalies, or unexpected findings.
   3. Encourage discussion among participants, allowing them to raise concerns, ask questions, and provide insights into the data.
   4. Ensure that any action items or decisions are documented clearly during the meeting. Assign responsibility for each action item and set deadlines for completion.
4. Step 4: Documenting Meeting Outcomes
   1. Document the meeting minutes, including a summary of the data reviewed, any issues or concerns raised, decisions made, and assigned action items.
   2. Ensure that all participants receive a copy of the meeting minutes promptly after the meeting for review and confirmation.
   3. Maintain records of the meeting minutes and related documents in accordance with study documentation and retention policies.
5. Step 5: Following Up on Action Items
   1. Track the progress of action items and ensure that they are completed by the agreed deadlines.
   2. Provide updates on action items during subsequent data review meetings to ensure that they have been addressed and resolved.
   3. If action items remain unresolved, escalate the issue to the study director or relevant stakeholders for further attention.
6. Step 6: Reviewing Data Integrity
   1. Ensure that data integrity is maintained throughout the study, and that any discrepancies or concerns are addressed promptly during data review meetings.
   2. Verify that all data is traceable, with a clear record of changes or updates, and that any deviations from the study protocol are documented and justified.
7. Step 7: Archiving of Meeting Records
   1. Ensure that all meeting documentation, including agendas, minutes, and supporting materials, are archived according to internal policies and regulatory requirements.
   2. Store meeting records securely, ensuring they are easily 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 data review process for preclinical studies:

1. Meeting Agendas
2. Meeting Minutes
3. Action Item Logs
4. Study Protocols
5. Data Review Records
6. Audit and Review Records
7. Sample 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 Data Review and Analysis

8) Version

Version 1.0: Initial version of the SOP.

9) Annexure

Data Review Meeting Template