Archives

What technology is used for long-term storage and archiving of study eTMFs?

The eTMF archiving mechanism is integrated into the core eTMF system. Once a study is unpublished, its content is transferred to a secondary content store optimized for secure, long-term retention. This secondary store supports immutability, metadata retention, and audit trails.

Is this long-term storage a separate solution, or is it part of the main system?

It is not a separate solution. The archiving feature is built into the core eTMF platform. The TMF status changes to reflect its lifecycle phase, but the system remains unified across active and archived states.

How are archived TMFs categorized and managed within the system?

  • Active Archive: The TMF remains fully accessible for audits and inspections.
  • Passive Archive: The TMF is offloaded to a cost-efficient, long-term storage layer. While no longer in active use, it remains retrievable with full integrity and compliance controls.

Is an architecture diagram available to illustrate this archiving concept?

The request for an architecture diagram is noted. A visual representation of the archiving concept can be shared upon request to support a clearer understanding of the infrastructure.

What is the current expected SLA for archival? Is it possible to reduce the time frame to less than two weeks?

This is dependent on the number of documents exported. The current SLA for archiving is set at one week per 10,000 documents. A ticket can be raised with the Trial Interactive Support team for additional details or optimization options.

Is it possible to provide checksum verification comparing archived content with what remains in TI?

Checksum files are exported along with the archive. These files can be included as part of the export package sent to the client and should be requested via the Archive Request Form.

What kind of encryption is used by default for ZIP files?

By default, AES-256 encryption is used when zipping folders.