Documents FAQs

Answers to some of the most frequently asked questions (FAQs) about working with documents in SiteVault.


General

  • Why should I manage all document versions, including previous versions, in SiteVault?

    SiteVault automatically maintains version control so that teams can be confident that they’re working and collaborating on the current version of a document, while also maintaining access to previous versions.

    Document versioning is useful in a number of ways, for example, when a document requires changes or when you need to resolve monitor feedback. SiteVault stacks the new version of the document on top of the previous version so that you can easily view all versions in one place. You can even compare the versions to see the differences.

    When you create a new approved version of a previously approved document (such as updating a 1.0 document to a 2.0 version), SiteVault automatically updates the status of the previously approved version to Superseded. Although the older version remains in the system, you can no longer edit the document.

  • What's the difference between the Library and eBinder?

    The Documents > Library tab displays all documents that you have access to in SiteVault regardless of lifecycle state, for example, Draft, Current, or Superseded. When you upload a document, the document is uploaded to the document library rather than to an eBinder folder. Once you move the document to its steady state (such as Current or Final), the document is automatically filed to your study eBinder.

    The Documents > eBinder tab only displays steady-state documents such as Current or Final for the currently selected study. Where the document is filed in the eBinder is determined by the document type.

    See the Study eBinder & Document Library page for more information.

  • How do I send training logs to a sponsor?

    Complete the following steps to send training logs to a sponsor:

    1. Navigate to the Reporting > Reports tab, and open the Training Material Report by Study (Training Log) report.
    2. Select the study in the dialog box, then select Continue.
    3. Select Export to PDF from the actions menu (...) of the report.
    4. Upload the exported report as a document of type Training Evidence (study-specific), and change the state of the document to Final.
    5. Send the report to your sponsor. If your study is a Connected Study, see the Sending Documents to Sponsor/CRO page for information on sending the document directly to the sponsor or CRO from SiteVault.
  • Why is my document not displayed in the eBinder?

    If your document isn’t displayed in the study eBinder, you can use the following list to troubleshoot any possible issues:

  • Why can't I edit the document types or eBinder structure?

    Sites from all over the world use SiteVault, so standardization ensures that all sites can use SiteVault efficiently and effectively. At your site, this standardization provides consistent eBinder structure and study documents across all your studies, regardless of the sponsor. Using a standard folder structure helps all SiteVault users quickly find documents and identify any missing documents. The standard structure also facilitates the automatic filing of documents in SiteVault, which greatly decreases your administrative burden.

    If you have questions about where a document is filed in the eBinder, use the eBinder Quick Reference Card. This resource shows where particular document types are filed in the eBinder. You can also use the Document Types Reference Spreadsheet. This resource covers all of the document types available in SiteVault and includes descriptions and other important information for each document type.

    We’re always looking for feedback and recommend letting our product team know whether additional eBinder folders or document types are needed. The more feedback you provide, the greater likelihood of us adopting the feedback, especially when the same feedback comes from multiple sites.

  • Why can't I redact documents in SiteVault?

    SiteVault is HIPAA-compliant and capable of storing unredacted documents. For source documents, SiteVault does prompt you to select whether the uploaded document has redactions.

    Our sponsor partners prefer that documents remain unredacted to perform source document verification effectively. When documents are redacted, it’s more difficult to perform source data verification or monitor review. Note that external users such as monitors or CRAs cannot download source documents.

    We encourage you to follow your site’s SOPs regarding redactions in SiteVault while also consulting the trial agreements with the sponsor or CRO for any study-specific requirements.

Creating Documents

Finalizing Documents

Editing and Deleting Documents

  • How do I edit documents in SiteVault?

    SiteVault has several features that enable you to edit documents and facilitate real-time collaboration. The following features a few for you to consider:

    • The annotate tool enables you to leave a comment on a document that other users can see.
    • You can check out documents to make edits. The checked out document is downloaded to your computer where you can make edits and check back in when finished. SiteVault automatically upversions the document for you.
    • With the version compare feature, you can compare versions of a document to see what changes were made between the two versions.
  • How do I delete documents?

    See the following help for information on how to delete documents:

    • Deleting Draft Documents: Learn how to delete documents that are in the Draft state.
    • Deleting Steady-State Documents: For Site Administrator users, learn how to delete all versions of a steady-state or major version document, for example, a Current, Final, or Approved for Use document.

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