4) Procedure

The following steps outline the procedure for managing and archiving preclinical study data:

1. Step 1: Data Collection
   1. Collect raw data from all study phases, including observations, sample measurements, analytical results, and any other information relevant to the study.
   2. Ensure that all data is recorded in a standardized format and that all necessary details (e.g., time, date, sample ID) are included to ensure traceability.
   3. Ensure that data is recorded either electronically or in hard copy, depending on the nature of the study and data storage systems available.
2. Step 2: Data Review and Validation
   1. Ensure that all data entries are reviewed for accuracy and completeness by appropriate personnel, including researchers and study directors.
   2. Check for any discrepancies or anomalies in the data and resolve them before proceeding to further stages of data analysis and archiving.
   3. Document any deviations from the study protocol or discrepancies found during the review process, including corrective actions taken.
3. Step 3: Data Backup
   1. Ensure that all data is backed up at regular intervals to prevent data loss. This can be done through electronic backup systems or physical copies stored in secure locations.
   2. Ensure that backup systems are tested regularly for integrity and reliability, and that backup data is stored in a separate location from the primary data to prevent loss due to disasters.
4. Step 4: Data Organization
   1. Organize the data in a structured format that allows easy retrieval. This may include creating folders and labeling files according to a standardized naming convention (e.g., study ID, date, sample type).
   2. Ensure that all data is categorized according to its type (e.g., raw data, analysis logs, final reports) and that files are clearly labeled for identification.
5. Step 5: Data Storage
   1. Store data in a secure and controlled environment, such as a validated electronic database or physical storage facility that complies with GLP standards.
   2. Ensure that data storage is temperature-controlled (for biological samples) and that electronic data storage systems are password-protected and secure from unauthorized access.
   3. Store data for a minimum of 5 years or as required by the applicable regulatory guidelines or company policies.
6. Step 6: Data Archiving
   1. Once the study is complete and all data has been validated and reviewed, archive the data according to GLP guidelines and company policies.
   2. Ensure that archived data is preserved in its original form (e.g., electronic or hard copy) and that all necessary documentation is included in the archive.
   3. Label archived data with appropriate identifiers (e.g., study number, storage location) to facilitate future retrieval if necessary.
7. Step 7: Data Retrieval
   1. Establish a clear protocol for retrieving archived data, ensuring that personnel can access the data when needed for regulatory audits, internal reviews, or future studies.
   2. Ensure that data retrieval is documented and that any changes to archived data (e.g., updates or corrections) are recorded and tracked.
8. Step 8: Data Disposal
   1. Dispose of data according to applicable regulations and policies once the retention period has passed.
   2. Ensure that all discarded data is destroyed securely, especially sensitive information or personal data that may be included in the study records.
   3. Document all data disposal actions, including the reason for disposal and the method used (e.g., shredding, electronic data deletion).

5) Documents

The following documents should be maintained during the data management and archiving process:

1. Study Protocols
2. Raw Data Logs
3. Data Backup and Recovery Logs
4. Data Review and Validation Reports
5. Study Reports and Final Data
6. Data Storage and Archiving Logs
7. Data Disposal Records

6) Abbreviations

• GLP: Good Laboratory Practices
• QA: Quality Assurance
• Cmax: Maximum Plasma Concentration
• AUC: Area Under the Curve
• FDA: Food and Drug Administration

7) References

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

• OECD Principles of Good Laboratory Practice (GLP)
• FDA Guidelines for Data Management and Archiving
• ICH Guidelines for Nonclinical Safety Testing

8) Version

Version 1.0: Initial version of the SOP.

9) Annexure

Data Management and Archiving Report Template