Study Archive FAQs

Why would you archive a study?

Global clinical trial regulations define requirements for retaining clinical trial documents (archiving). These regulations require that, at the conclusion of a study, relevant records and their audit trails must:

Be retained for a period of up to 25 years (year requirement varies by region)
Be protected from unauthorized changes
Have “suitably restricted” access, yet be readily available for inspection purposes
Provide for identification, version history, search, and retrieval

When should a study be archived?

A study should be archived once all work is finished and all study records are accounted for and complete.

Who can archive a study?

Research Organization and Site Administrators

Can I reverse an archived study back to active?

No, the archival process cannot be reversed.

Who can access an archived study?

Site Administrators retain access to studies in all statuses. Administrators can reactivate or create new Study Team or Monitor and Auditor assignments.

How long will SiteVault retain archived study data?

Per our Terms of Service, Veeva will retain all documents for at least 25 years regardless of the timeframe reflected in the Retention Period End Date field.

What happens when a study is archived?

See the Study Archival Automated Actions on the Study Archive Overview page.

Can I archive several studies simultaneously?

Research Organizations are limited to one study archive request at a time. When an archival is in process, and an additional archival is initiated on another study within the Research Organization, the request generates an error advising the user to reattempt once the first archival has completed.

Can I archive an individual document into an archived study?

In SiteVault, the intent is to archive entire studies, rather than individual documents. When a study document is found after archival or a document is unarchived for an update, the entire study is archived again to add it back to the archive.

The Archive Document action listed in a document’s All Actions menu is a system tool that is not used in SiteVault. This action will archive a document for a study that has not yet been archived, protecting the document by removing it from all users’ visibility. Should this action be selected in error, complete the following steps: contact Site Support.

Access Documents > Library.
Access the Search Bar.
Select Advanced Search.
Select Yes for Search Archives.
Use the provided fields to narrow your search results.
Select Search.
Select the appropriate document.
Select Unarchive Document from All Actions (…).
Select Confirm.

Access Documents > Library.
Access the Search Bar.
Select Advanced Search.
Select Yes for Search Archives.
Use the provided fields to narrow your search results.
Select Search.
Select the appropriate document.
Select Unarchive Document from All Actions (…).
Select Confirm.

Can you upload new person or organization profile documents to a study after it’s archived? If so, how would this be done since you cannot add a person or org to the study?

No, this is not allowed. Options include uploading the file as a different (non-profile) document type or contacting Veeva Support for help.

How much does it cost to archive a study for 25 years (EU-CTR requirement)?

There are no costs associated with archiving a study.

Can a study be re-archived or changed back to active?

A study can be archived several times (to add additional documents). However, a study cannot be reversed out of the Archived state.

Is there a clear cut way to tell which studies are archived (gone through the process) vs just studies that are currently listed as archived in our vault?

You can create a report to pull all archive Note to File documents. If you need assistance with this, you can reach out to Site Success.

Can you change the retention period?

You can request a change of retention period through Site Support.

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