On This Page
- Creating Documents Using the Create Button
- Creating Documents Using the Document Inbox
- Completing Unclassified Documents Using the Document Inbox
- Editing Documents
- Creating New Draft Versions
- Making a Copy of a Document
- Re-Rendering Documents
- Comparing Documents
- Deleting Documents
- Viewing Deleted Document Records and Audit Trails
- Using Cart
Creating Documents Using the Create Button
Note The steps in this section are for uploading study regulatory documents and profile documents (such as CVs and Licenses) to SiteVault. For participant source documents, see the Managing Source Documents & Monitor Reviews page.
Complete the following steps to create one or more SiteVault documents using files on your computer or local file server as source files:
- Complete one of the following actions:
- From the Documents > Library tab, select Create, select Upload in the Create Document dialog, then select Continue.
- Select Document from the Create list, select Upload, then select Continue.
- To select files, drag and drop them into the blue area or select Choose. Uploading multiple files creates multiple documents.
- Complete the following steps to classify the documents now:
- Select Classify documents now, then search for and select the document type. This selection determines the relevant document fields, lifecycles, and workflows.
- Select Next. SiteVault begins uploading the files and shows the progress on the page.
- Complete the fields. An asterisk (*) indicates required fields. You can complete these fields before the upload completes. If you’re adding multiple documents at once, you’ll see a grid of documents in Step 2 of adding content. To complete the fields, select one or more documents using the checkboxes, and enter or choose fields in the right panel. Select Apply when you’re finished populating the fields for the selected documents.
- Select Save. If the Save button is disabled, the upload is not complete or required fields are blank.
- The uploaded document is now available in the Library. Depending on the file size, the thumbnail and viewable rendition can take several minutes to appear.
- To classify the documents later, select Classify documents later and select Upload. The documents are placed in your Document Inbox.
Note You will need to complete (classify) the documents to move them to another state, for example, Approved or Final.
Creating Placeholder Documents
Complete the following steps to create a place for a file that you expect to upload at a later time:
- From the Documents > Library tab, select Create then select Placeholder.
- Search for and select a document type, then select Next.
- Complete the fields. An asterisk (*) indicates required fields.
- Select Save.
Creating Documents Using the Document Inbox
Uploading Unclassified Documents
The Document Inbox displays unclassified documents to which you have access. These are documents that do not yet have an assigned document type.
To upload unclassified documents using the Document Inbox, drag and drop the files from your computer directly into your Document Inbox. You can drag and drop up to 250 files at a time. Optionally, apply fields such as Study, Organization, and Person for the documents in bulk using the Bulk Apply Fields dialog.
Note If the Bulk Apply Fields dialog is not displayed when uploading files to the Document Inbox, you can re-enable it by selecting Enable Bulk Update on Upload from the Document Inbox’s Actions menu.
When SiteVault begins to upload files that you’ve dropped into your Document Inbox, you’ll see a dialog in the bottom-right corner that lists the status of all files you are uploading. While SiteVault is uploading your files, you can drag and drop additional files or navigate to other pages in SiteVault while monitoring the progress in the status dialog. Select Navigate to Inbox on the collapsible dialog to navigate back to the Document Inbox from anywhere in SiteVault.
The color of the arrow icon on the status dialog indicates the status of the upload. Selecting the X icon after all uploads are complete removes the status dialog from your view. If necessary, refresh your browser window to view the uploaded files once the upload is complete. Note that closing your browser, browser tab, or refreshing your page before the file upload is complete cancels all remaining uploads.
Completing Unclassified Documents Using the Document Inbox
Complete the following steps to complete (or classify) one or more documents in the Document Inbox:
- Select one or more documents, then select the Complete button or select Complete from the Actions menu.
- Search for and select a document type in the Classify Document dialog, then select OK.
- If you selected just one document, complete the fields. An asterisk (*) indicates required fields.
- If you selected more than one document, select one or more documents using the checkboxes, and enter or choose fields in the right panel. Select Apply when you’re finished completing the fields for the selected documents.
- Select Save. The document or documents are moved to the Library.
To edit document fields, select any document from the Library and select Edit Fields on the Doc Info page.
Creating New Draft Versions
You can create a draft of an existing document that is currently in a major version to start a new drafting cycle.
Complete the following steps to create a new draft version of a document:
- Select Create Draft from the Actions menu.
- Upload the new version’s source file, or copy and reuse the current source file.
- Enter a description of the new version. Other users can view this description in the document’s version history.
After uploading the document, SiteVault creates a new minor version and sets the document status to the starting state for the associated lifecycle, typically Draft. When creating a new draft version, SiteVault increments the version number by 0.1. For example, if the document is version 1.0, the new draft is version 1.1.
Making a Copy of a Document
You can reuse documents in SiteVault by using the Make a Copy action. Complete the following steps to copy a document:
- From the document’s Actions menu, select Make a Copy.
- In the Make a Copy dialog box, enter a name for the document, select whether to copy the document’s content or fields or both, then select Continue. The Doc Info page for the copy is displayed.
- Optionally, update the document fields in the General section as needed.
- Select Save.
In rare circumstances, SiteVault may not successfully generate a viewable rendition of your document. Re-rendering the document may solve issues that you’re having and will replace the current viewable rendition for the document version with a new rendition.
Complete the following steps to re-render a document:
- From the document’s action menu, select Re-Render Document.
- If applicable, select an option or options in the Re-Render dialog, then select OK.
During a document’s complete lifecycle, it can undergo many changes. SiteVault enables you to compare two versions of a document to see what has changed between them. Note that you must have View Content and View Document permissions on both versions.
If a document has more than one version, the Version History section is displayed in the Doc Info page. To compare the current version with a past version, select Compare Versions from the Actions menu. You can also access this option from the Version History dialog box.
When you compare two versions, SiteVault opens the document in comparison mode. In this mode, inserted text is highlighted in purple and deleted text is marked with a note. You can close comparison mode using the Back to previous page link.
The following limitations apply to document comparison:
- SiteVault only detects changes to the text, not images, formatting, page additions or removals, or other structural changes.
- SiteVault cannot detect changes in text that is not searchable, for example, text in image files.
- When large portions of a document change, or when a document changes structurally, the number of changes can be so large as to make document comparison unhelpful.
- When SiteVault detects more than 5,000 distinct changes between versions, it does not display any changes.
- SiteVault does not add a note for text deleted from the end of a document. To see content removed from the end of a document, you must compare a previous version that has the removed text with a newer version that does not have the text. The missing text is considered an addition and is highlighted in purple.
- In rare cases, SiteVault detects extra spaces that do not exist. This causes unchanged text to be highlighted as changed.
Deleting Draft Documents
Study Team users can delete versions of documents that they created as long as the document is still in the Draft state (a document version such as 0.1 or 1.1). Regulatory users can delete any draft document, regardless of who created it.
Complete one of the following actions to delete a draft document:
- Documents that have never had a major version (for example, version 0.1): Select Delete from the Actions menu of the document that you want to delete, then select Delete in the dialog box. This action also deletes all versions (if they exist) of the document. If you only need to delete a specific version of the document, expand the Version History section of the document’s Information panel, and select Delete from the Actions menu for that version.
- Documents that have a major version (for example, version 1.1): Expand the Version History section of the document’s Information panel, select Delete from the Actions menu for that version, then select Delete in the dialog box. This action removes the specific version but leaves all other versions of the document. If you need to delete all versions, a Regulatory user can use the Delete All Versions action below.
Deleting Steady-State Documents
Regulatory users can delete documents that are in a steady state, for example, Final or Current. Doing so permanently deletes all versions of the document, including any draft and superseded versions. When you delete all versions of a steady-state document, SiteVault retains an audit trail of the document but you cannot access or recover the document’s file or content.
Complete the following steps to delete all versions of a steady-state document:
- From the document’s Actions menu, select Delete All Versions.
- In the dialog box, select a reason for the deletion, enter any optional comments, then select Continue. SiteVault closes the dialog box and removes all versions of the document while retaining the document’s audit trail for compliance purposes.
Viewing Deleted Document Records and Audit Trails
Regulatory users can view and export a list of deleted document records along with an audit trail. Study Team & External users do not have access to this information.
Complete the following steps to view deleted document records and audit trails:
- To view deleted document records, navigate to Reporting > Deleted Document Records.
- If you want to view additional details and access the audit trail for a record, select the link in the Details & Audit Trail column.
- If you want to view the audit trail, expand the Full Document Audit History section and select the link for the audit trail.
With Cart, you can quickly create an ad hoc group of documents from multiple filter sets and Library views. From your cart, you can download source files or viewable renditions or initiate bulk document actions like Edit Fields and Change State. After performing your actions, there’s a quick option for emptying your cart, leaving it ready for the next time you need it.
Your cart serves a different purpose than Favorites, which are more useful for storing a list of documents that you reference frequently. Like Favorites, your cart is specific to you. No other user can see your cart.
If there are documents in your cart that you can no longer view, SiteVault displays a warning and automatically removes them when you next access your cart.
To access your cart, select Cart [Number] on the primary navigation bar. The number that is displayed above the button indicates the number of documents currently in your cart. If more than 99 documents are in your cart, 99+ is displayed.
How to Add and Remove Individual Documents
The Cart [Number] button is available in the Library, all document tabs, and the Doc Info page.
A green plus (+) symbol on the button indicates that you can add the document to your cart. If the button is unavailable, your cart contains the maximum number of documents allowed.
A red minus (–) symbol on the button indicates that the document is already in your cart. Selecting removes the document.