A clear and structured definition of essential records, data and metadata elements is critical to ensure that all information needed to accurately reconstruct the conduct of a clinical trial is preserved, and this is a sponsor responsibility. This involves identifying them, designating these elements for long term archival, and confirming that they have been archived before the associated trial is decommissioned from a system.
This Computerised Systems Essential Records (CSER) list is designed to support sponsors in identifying, selecting, and documenting the essential data and metadata that must be retained to accurately reconstruct the conduct of a clinical trial after decommissioning from the computerised system. Users are free to add and modify this list based on their own requirements. Please see the Disclaimer and License tab.
This list will evolve alongside new technologies and updates to existing systems.
Sponsors should use this list as a reference to identify:
- Study-specific essential records
- System-specific metadata requirements
- Audit trail elements required for compliance
Sponsors should ensure that all required data and metadata in the archival package preserves the context and meaning necessary for accurate reconstruction.
This list is a companion to the eClinical Forum and European CRO Federation (EUCROF) previously published position paper and three associated white papers dealing with the archiving of electronic records and the decommissioning of computerised systems used in clinical trials. These can be downloaded from the eCF and EUCROF websites.
- “Decentralized TMF Archives and The Decommissioning Of Computerised Systems Used In Clinical Trials” (Position paper)
- “Nature of a Distributed Trial Master File ‐ Practical Aspects”
- “The Decommissioning of Computerised Systems Used in Clinical Trials”
- “Data Formats Used in Clinical Trials”
- "eCF_Essential_Records_PR2" - Dashboard
To download the resources, see the links below.
These resources together provide foundational principles for ensuring long-term accessibility and compliance.