When you're ready to archive an eISF, there are a number of steps that need to be followed to ensure you have accounted for all documents that require archiving. Ensuring the inclusion of documents such as your personnel documentation (eg. CVs, GCP), laboratory reference ranges used during the lifespan of the study at your site, is key.
In addition, you may require a complete document download of all documents contained within the eISF. This download can then be sent for archival storage at an off-site facility if required, or held on site as an additional backup for the required retention period (generally around 15 years).
Step by step instructions on how to archive an eISF can be found in the attached document: