Site eBinder

Use the Site eBinder to store and manage your non-study-specific documents, such as medical licenses, work instructions, or IRB documentation.


Site eBinder Overview

The Site eBinder organizes your site documents, or documents that provide evidence of your site’s internal processes and operations. Within the Site eBinder, you can filter for helpful views, upload documents, or initiate state changes and workflows.

Site Documents

While a sponsor or monitor may request to review these documents for your site to participate in a study, they are not related to any specific study. Some Site Documents may be filed to a study in the Study eBinder, but remain visible in the Site eBinder.

Document Types

  • Visible only in Site eBinder
    • SOPs & Policies Folder
      • Policy Memo
      • Standard Operating Procedures (SOP)
      • Work Instructions
  • Visible in Site and Study eBinders
    • Staff Folder
      • CV
      • Medical License
      • Signature & Initials
      • Training Evidence
    • Partner Organizations Folder
      • IRBs/IECs Folder
        • IRB/IEC Compliance
        • IRB/IEC Composition
      • Labs Folder
        • Lab Certification
        • Lab Director Qualifications
        • Lab Normal Ranges

Permissions

  • External users cannot access the Site eBinder; any sharing of Policy Memo, SOP, and Work Instruction document types would occur outside of SiteVault.
  • Documents cannot be uploaded in the Research Organization context.
  • Admin and Staff users can upload to the Site eBinder
  • Only Admin users can upload or view draft versions of Policy Memo, Standard Operating Procedures, and Work Instruction document types.

Finding Documents

Use the tools below to easily locate and file documents in the Site eBinder.

  1. To review documents in the Site eBinder, select the Documents > Site eBinder tab, if needed, select a site from the Site Selector.
  2. The document folders on the left side of the screen provide easy navigation.
    • Hierarchical folder structure is grouped by Document Type.
    • 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.
  3. Descriptions are displayed for all folders and documents as they are selected.
  4. In addition to selecting folders, filters are provided to assist in locating documents.
    • The Site eBinder Search bar (located above eBinder table) is available to locate documents in the currently selected folder.
    • Use filters to locate documents related to a specific organization or person.
    • The Show Drafts toggle button provides the option to include draft versions for users with the appropriate permissions.
  5. Documents are listed in the table on the right side of the screen. Table columns update based on folder selection.
    • Selecting a document will open the Library view of the document in a new browser window.
    • The Document Actions menu provides tasks (ex. 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.
    • Documents with previous versions available display a caret (>) 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. Your folder level preferences are retained for future ease of use.
  6. The Upload button initiates the Site eBinder document creation process.
eBinder Navigation



Site eBinder Tasks

Uploading Documents

Upload Documents The Site eBinder upload process includes the option to move documents to their steady state and/or initiate a workflow. Documents uploaded to the eBinder are also present in the Document Library.

Complete the following steps to upload documents directly to the Site eBinder:

  1. Access the Site eBinder.
  2. Select one of the following upload methods:
    • Upload (select the Upload button):
      • Select the locally saved documents.
      • Select Open.
    • Drag and Drop:
      • With Site 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.
  3. 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.
    • Additional Actions:
      • To perform Copy Certification, select Additional Actions > Perform Copy Certification.
        • If the document is a Source document, verify if the document is an exact or redacted copy.
      • To initiate a workflow, select the appropriate workflow from Additional Actions.
        • Complete the required fields in the Start Workflow dialogue.
    • 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 (ex., Version date, approval date, log end date, meeting date, etc.).
    • Complete the optional Start Date field. This date should reflect the earliest date of recording/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 applicable, complete the Expiration Date field with the date on which the document is due to expire.
    • Populate the remaining fields.
  4. Select Save to complete the process.

Bulk Upload Profile and Organization Documents

Complete the following steps to bulk upload documents directly to the Site eBinder:

  1. Navigate to the Documents > Site eBinder tab.
  2. Expand the Upload dropdown menu to select one of the bulk upload options.
  3. Select one of the upload methods below:
    • Browse your local folders
      • Select the locally saved documents.
      • Select Open.
    • Drag and Drop
      • With the upload dialog open, select the locally saved documents on your computer.
      • Use your cursor to drag the documents from the local folder into the blue area of the dialog.
  4. Complete the required and any additional optional fields as needed. Note: You can apply the same content to all fields in a column by populating the header row field. Individual fields can be adjusted at the row level, as needed.
  5. Select Save to complete the process.



Tasks Available from the Document Actions Menu

Finalize a Document and Perform Copy Certification

Complete the following steps to move a document to its final state and if needed, perform copy certification:

  1. Locate the document in the Site eBinder.
  2. Select the Document Actions menu (…) to the right of the document name.
  3. Select Change Status to XXXX where “XXXX” is the document type’s final status.
  4. Complete the Document Date field.
  5. 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.

Initiate Workflow

You can initiate workflows from the Document Actions menu. These options are available based on the document type and status.

  1. Locate the document in the Site eBinder.
  2. Select the Document Actions menu (…) to the right of the document name.
  3. Select the appropriate workflow.
  4. Complete the required fields in the Start Workflow dialogue.
  5. Select Start to begin the workflow.

Download Document

Complete the following steps to download a document from the Site eBinder:

  1. Locate the document in the Site eBinder.
  2. Select the Document Actions menu ellipses (…) to the right of the document name.
  3. Select the preferred download option:
    • Source File: The original document uploaded to Vault
    • Viewable Rendition: A PDF rendition of the document

Study eBinder
Creating & Finalizing Documents

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