Learn about the Study eBinder, where documents are organized by study and document type.
eBinder Overview
The Study eBinder organizes documents by study, offering helpful views for internal and external users focusing specifically on study document progress. The Study eBinder is the equivalent of pulling your eRegulatory binder or ISF off the shelf. Each folder represents a set of documents, and upon expanding the folder, you can find each document type available for upload.
Finding Documents
Use the tools below to easily locate and file documents in the eBinder.
- To review a study in the eBinder, select the Documents > eBinder tab, then select a study from the Study Selector in the upper-left corner.
- The document folders on the left side of the screen provide easy navigation.
- Hierarchical folder structure is grouped by Document Type.
- View documents of a specific type or related to a specific section of a study.
- Folder descriptions of the expected contents are visible on hover or once a folder has been selected.
- Document indicators and counts provide at-a-glance folder activity.
- Descriptions are displayed for all folders and documents as they are selected.
- In addition to selecting folders, filters are provided to assist in locating documents.
- The eBinder Search bar (located above eBinder table) is available to locate documents in the currently selected folder.
- Use the Participant filter to locate documents related to a specific study participant.
- The Show Drafts toggle button provides the option to include draft versions for users with the appropriate permissions.
- Documents are listed in the table on the right side of the screen.
- Selecting a document will open the Library view of the document in a new browser window.
- The Document Actions menu provides tasks (for example, change status, download, etc.) that are available based on document type and status. To review, select the ellipses menu (…) to the right of the Document Name.
- A caret is displayed (>) for documents with previous versions available to expand or collapse the view as needed. This viewing option is only available for documents to which the user has access.
- Select Edit Columns from the table-level ellipses menu (…) to add or remove columns.
- The Upload button initiates the eBinder document creation process.
Document States in eBinder
- Document states (Status column) convey a document’s lifecycle progress.
- The eBinder default view (“inspection view”) displays only steady state or major versions (Approved for Use, Current, Superseded, etc.).
- The Show Drafts toggle button provides the option to include Draft or minor versions.
- User permissions determine the Show Drafts toggle button visibility:
- Site staff can use the Show Drafts toggle button as they often prefer the “working view” of eBinder, which includes document versions in the Draft state. This view helps them to identify needed actions or tasks.
- External users are limited to the “inspection view”, displaying only the approved and effective documents for the selected study.
eBinder Quick Reference Card
The eBinder Quick Reference Card lists all Document Types and their related eBinder section.
Available Tasks
The tasks below can be completed from the Study eBinder.
Upload Documents
- Documents uploaded to the eBinder are also present in the Documents Library.
Complete the following steps to upload documents directly to the Study eBinder:
Note The fields that are displayed in the Details section mostly depend on the Document Type selected in Step 2.
- Access the Study eBinder.
- Select one of the upload methods below:
- Upload (select the Upload button)
- Select the locally saved documents.
- Select Open.
- Drag and Drop
- With eBinder open, select the locally saved documents on your computer.
- Use your cursor to drag and drop documents from a local folder to an eBinder folder or the eBinder table.
- For each document:
- Select the Document Type.
- Select the upload state:
- Draft: The document requires additional processing/review (updates, signatures, etc.).
- Final State: (state label depends on Document Type chosen in the previous step): Document is complete with no further processing needed.
- If Copy Certification is needed, select Additional Actions > Perform Copy Certification.
- If the document is a Source document, verify whether the document is an exact or redacted copy.
- Enter a description of the document. Include details not captured in other document fields.
- Complete the Document Date field with the most meaningful date to uniquely identify this document version (for example, Version date, approval date, log end date, meeting date, etc.).
- If available, complete the optional Start Date field. This date should reflect the earliest date of recording or capturing in this document. The latest date of data recording in this document should be added in the Document Date or End Date fields.
- If available, the Expiration Date field with the date on which the document is due to expire.
- Populate the remaining fields.
- Select Save to complete the process.
See the Uploading Documents to the Study eBinder training video for more information.
Bulk Upload Source Documents
The standard eBinder upload allows you to upload up to 20 documents at a time including source; the Bulk Upload Source Docs feature allows up to 100 source documents at a time. For these steps and more about Source Documents, see Managing Source Documents.
View Previous Versions
Internal users can view previous versions of a document in the eBinder. You can also view all document versions in the Library.
Complete the following steps to view previous versions of a document in eBinder:
- Locate the document in the eBinder.
- Use the caret (>) to expand or collapse previous document versions.
The tasks below can be completed from the eBinder Document Actions menu.
This action is available on documents of most document types in the Draft state.
Complete the following steps to move a document to its final state and if needed, perform copy certification.
- Locate the document in the eBinder.
- Select the Document Actions (…) menu to the right of the document name.
- Select Change Status to {XXXX} where XXXX is the document type’s final status.
- Complete the End Date field.
- Additional Actions:
- If no further actions are required, select Save to complete the process.
- If copy certification is required, select Perform Copy Certification.
- Complete the copy certification.
- Select Save to complete the process.
Change State to Superseded
Documents that have been replaced by a new version or archived can be moved to a superseded state. The action is only available on the current major version of a document. If the action is not displayed or is displayed but unavailable, your current system role doesn’t include permissions to supersede a document.
Complete the following steps to move a document to the Superseded state:
- Locate the document in the eBinder.
- Select the Document Actions (…) menu to the right of the document name.
- Select Change State to Superseded.
- Select Yes to confirm your intent.
Create Draft from Original Document
If you need to update a document that is in its final state or is a major version (ex., adding a new version of a site staff member’s CV), you can create a draft of the document to start a new drafting cycle. SiteVault stacks the new version on the original document as a new Draft version.
Complete the following steps to create a new draft version of a document.
- Locate the document in the eBinder.
- Select the Document Actions (…) menu to the right of the document name.
- Select Create Draft from Original Document.
- Complete the optional Version Description field (visible in the document’s version history).
- Select Create to complete the process.
Share Document with Participants
You can share specific documents with study participants and their signatories through the MyVeeva for Patients app.
Complete the following steps to move a document to its final state, and if needed, perform copy certification.
- Locate the document in the eBinder.
- Select the Document Actions (…) menu to the right of the document name.
- Select Share with Participants.
Download Document
Complete the following steps to download a document from the eBinder.
- Locate the document in the eBinder.
- Select the Document Actions (…) menu to the right of the document name.
- Select the preferred download option:
- Source File: The original document uploaded to Vault
- Viewable Rendition: A PDF rendition of the document
Delete Annotations
Completing this action will permanently delete all annotations on all versions of a document.
Complete the following steps to delete all annotations on all versions of a document.
- Locate the document in the eBinder
- Select the Document Actions (…) menu to the right of the document name.
- Select Delete Annotations.
- Select Start to confirm your intent.
- Complete the process.