CDISC standard-based electronic archiving of clinical trials

Area of Science:

• Clinical research informatics
• Data management and archiving
• Regulatory compliance in clinical trials

Background:

• Clinical trial archiving requires legally secure and technically feasible solutions for essential documents and study databases.
• Existing archiving methods face challenges due to the complexity and size of trial master files.
• Good Clinical Practice (GCP) guidelines necessitate robust electronic archiving.

Purpose of the Study:

• To develop a concept for legally secure and technically feasible archiving of entire clinical trials.
• To address the requirements of GCP-compliant electronic archiving for trial master files and study databases.
• To evaluate CDISC standards for their suitability in clinical study archiving.

Main Methods:

• Analysis of archived clinical trial documents and data from small, medium, and large studies.
• Evaluation of CDISC (Clinical Data Interchange Standards Consortium) standards, including ODM and SDTM, for archiving requirements.
• Assessment of existing implementations and future developments in CDISC standards.

Main Results:

• Two primary archiving methods identified: document-oriented and data archiving of study databases.
• The CDISC ODM standard is suitable for archiving clinical trial data and audit trails.
• CDISC developments like "eCRF submission" and "Electronic Source Data" impact study archiving.

Conclusions:

• The complexity of trial master files necessitates integrated archiving solutions.
• While ODM effectively archives study databases, challenges remain in joint archiving of data and complex documentation.
• An integrated concept using ODM for data, PDF/A for documents, and SDTM for data warehousing ensures GCP-compliant, long-term archiving.