Clinical Data Archiving and Retention are important components of the “Close Out” phase of Clinical Data Management. Regulatory requirements mandate the retention of all records and data collected during clinical trials. In addition to retaining the data, there is also a requirement to archive all the data in a single platform for a specified period. Every clinical trial should draft a Clinical data management plan or strategy for managing the data during the different stages of its lifecycle. In the data management plan, there will be a dedicated section to address the data archival and retention.
Clinical Data Archiving:
It refers to the planned preservation of clinical trial data on low-cost and portable storage platforms for future reference.
Clinical Data Archiving – Key Benefits:
- Reduction in the overall cost of data preservation moving data to the lower cost licensed data warehouse applications.
- Clinicians can gain on-demand access to archived patient history records.
- Improvement in system performance as archiving reduces the load on the existing system.
- Reduces cumbersomeness as disconnected data from different repositories are integrated on a single platform.
Clinical Data Retention:
It refers to the period or duration for which the clinical trial data is retained by the respective research teams based on the specific type of research and the organizational standard operating procedures.
Clinical Data Retention – Key Points to Ponder:
- Different studies can have different data retention needs depending on state, territory, or national legislation. For instance, in the Netherlands, certain types of research with medical devices call for a minimum retention period of 10 years and other types of research with advanced therapy medicinal products call for a minimum retention of 30 years.
- Responsibilities of data retention are vested with both the Sponsor – Investigator and all site Principal Investigators.
- Clear policies and standard operating procedures should be drafted to address the aspects of control or ownership of data retained.
Steps involved in Clinical Data Archiving and Retention:
- Data Classification: The first step is to classify data according to its type, importance, and relevance. Different types of data, such as raw data, metadata, case report forms (CRFs), and other study documents, may require different archiving procedures. Establish clear criteria for categorizing data.
- Data Preparation: Ensuring that the data is complete, accurate, and consistent. This may involve data cleaning and validation processes to address any errors or discrepancies.
- Metadata Management: Metadata is essential for understanding and interpreting archived data. Ensure that metadata, including data dictionaries and data structure descriptions, are well-organized and documented.
- Data Encryption: Security is a top priority. Before archiving data, encrypt sensitive information to protect it from unauthorized access or breaches, so that data remains confidential and secure during storage.
- Data Backups: Create secure backups of the data to prevent data loss. Regular backups should be performed to safeguard data integrity and availability. Backup copies should be stored in geographically separate locations.
- Data Indexing: Implement a robust indexing system that allows for efficient data retrieval. Indexing facilitates quick and accurate searches for specific data elements or documents within the archive.
- Archiving Platform Selection: Choose a suitable archiving platform or system that meets your organization’s requirements. This platform should provide secure and structured storage, user access controls, audit trails, and data retrieval capabilities.
- Data Transfer: Transfer the data and related documents to the selected archiving platform. Ensure that data is transferred in its original format and is preserved without any alterations.
- User Access Control: Establish and maintain strict user access controls. Only authorized personnel should have access to archived data. Implement a role-based access control system to manage permissions effectively.
- Data Verification: Conduct data verification processes to confirm that the archived data matches the original source data. Verification may involve comparing checksums, file integrity checks, and validation of data against predefined criteria.
- Audit Trails: Implement and maintain audit trails to track any changes or access to archived data. Audit trails help maintain data integrity and support compliance with regulatory requirements.
- Documentation: Thorough documentation is essential. Keep records of the archiving process, including data preparation, data transfer, and data verification activities. Document data structures and metadata for future reference.
- Regulatory Compliance: Ensure that the data archiving process aligns with relevant regulatory requirements, including FDA 21 CFR Part 11, EMA guidelines, and other applicable regulations. Maintain documentation to demonstrate compliance.
- Long-Term Preservation: Establish a strategy for long-term data preservation. Ensure that data archives are regularly maintained, and data remains accessible as technology and storage systems evolve.
- Archiving Records and Documents: In addition to data, ensure that all study-related documents, including protocols, investigator brochures, and case report forms, are properly archived. Documenting the archiving of these records is crucial.
- Data Destruction Planning: Develop a data destruction plan that outlines how and when data will be securely and permanently deleted once the retention period has expired.
- Data Retrieval and Compliance Checks: As part of ongoing quality control, periodically test, data retrieval capabilities to verify that archived data can be easily and accurately retrieved when needed, ensuring accessibility for potential audits and ongoing compliance checks.
- Periodic Auditing: Conduct regular audits of the archiving process to ensure that it complies with internal and external requirements.
In summary, clinical data archiving and retention are fundamental to the success of clinical research, regulatory compliance, and the advancement of healthcare solutions. By embracing best practices and staying beside of evolving regulatory guidelines, organizations can ensure the availability, integrity, and accessibility of clinical data for the long term. The objective is not merely regulatory compliance; it is the preservation of a valuable legacy of research and the assurance of safer, more effective healthcare solutions for the future. In the world of clinical research, data is not just information; it is the promise of a healthier, more informed tomorrow.
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