eTMF archiving myths and misconceptions
'Archiving data in your eTMF system will meet regulatory requirements'
eTMF systems are designed for collecting data, measuring and maintaining real-time timeliness, quality and completeness and providing a single source of truth for the conduct of the trial.
They are excellent solutions for running the trial and although they may appear to have all the features required for long term retention they fall short in a large number of areas.
Benefits
- Often already a Validated solution.
- The solution is already established and embedded in the organisation.
- Online availability with backups.
- Secure access controls.
- Benefits of in system metrics and analysis.
Dangers
- Files are stored in their original native format they were provided so there is no long term file format conversion.
- No integrity checks on data.
- Data is retained in a live state for the duration of its storage.
- Archived data is not really archived, just “locked” in a “read-only” state.
- Ownership stays within the system and system owner, not the archivist.
‘Can I store my data I store using a general Cloud Storage provider?’
The primary function of these solutions are designed to aid collaboration and act as a repository for content authoring, review, approval, collaboration, and day-to-day management of active content.
It’s therefore not an appropriate archiving solution, especially in relation to eTMF documentation, GCP and similar regulated data.
Benefits
- Often already in the business so no start-up time or requirement for buy-in.
- Provides online access to files.
- Useful collaboration tool.
Dangers
- Files are stored in their original native format they were provided so there is no long-term file format conversion.
- Integrity checks are difficult and involve long, often manual, processes and so not often performed.
- Single copies are stored unless manually duplicated.
- Limited and fixed metadata make search and discovery difficult and/or lengthy.
- No audit trails are captured of who has accessed or changed files (and not time-stamped either).
- The solution is not validated.
‘CROs should be responsible for the archival of the eTMF, not sponsors’
CROs play a major part in the running of your trial and provide Sponsors with a multitude of services and support. It is often assumed that CROs may be better equipped to handle the archival of the eTMF as opposed to sponsors. The truth is they have the same limitations as the above, as they will likely be using these solutions (or similar). This can bring more risk around accessibility, ownership and the inability to have a central location for all data. For example, sponsors often use multiple CROs which would result in multiple archives. Ultimately maintaining the data correctly is the sponsor’s responsibility and outsourcing that can cause issues.
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